Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-27 @ 9:15 PM
Study NCT ID:
NCT04678661
Status:
TERMINATED
Last Update Posted:
2024-02-14
First Post:
2020-12-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
My Dose Coach Mobile App to Support Insulin Titration and Maintenance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'similx@upmc.edu', 'phone': '412-559-0359', 'title': 'Dr. Linda Siminerio', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The trial was implemented during the COVID-19 pandemic and there were restrictions and challenges with meeting enrollment goals. Early on in the study, a technical issue with the intervention app was discovered and required that the study be paused while the issue was addressed, further impacting enrollment goals. Also, the study design included a historic control group to make best use of available resources, which limited comparisons among study groups.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 15, 'seriousNumAtRisk': 60, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild Hypoglycemic Event', 'notes': 'Mild/asymptomatic hypoglycemia - blood glucose \\<70 mg/dl and no symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycemic Control at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.207', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Propensity score matching was used to form pairs of intervention and control participants. Specifically, a greedy matching procedure with a matching caliper of 0.2 of the standard deviation of the logit of the propensity score was used.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for covariates of age, race, baseline BMI, and baseline hemoglobin A1c.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Average change in hemoglobin A1c from baseline to 3 months', 'unitOfMeasure': '% glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Using propensity score matching, 33 intervention participants were paired with 33 usual care participants to compare changes in hemoglobin A1c from baseline to 3 months.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Blood Glucose at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.4', 'spread': '68.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.011', 'groupIds': ['OG000'], 'groupDescription': 'Independent t-test', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Change in fasting blood glucose from baseline to 3 months for the intervention group.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes all intervention participants who completed the study and had fasting blood glucose values at both baseline and 3 month timepoints. Fasting blood glucose values were not collected for the historic usual care group so they were not included for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Blood Glucose at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.3', 'spread': '79.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.024', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Change in fasting blood glucose from baseline to 6 months for the intervention group.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intervention group who completed the study and had fasting blood glucose values recorded at time points of comparison. Data were not collected for the historic usual care group so they were not included for analysis of this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From 3 Months in Fasting Blood Glucose at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '42.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.579', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Months 3 to 6', 'description': 'Chang in fasting blood glucose from month 3 to 6 for the intervention group.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intervention group who completed the study and had fasting blood glucose values recorded at time points of comparison. Data were not collected for the historic usual care group so they were not included for analysis of this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin A1c at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'pValueComment': 'Reported p-value was calculated.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Average change in hemoglobin A1c from baseline to 6 months for the intervention group.', 'unitOfMeasure': '% glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the intervention group with available hemoglobin A1 data at the specified time points were included. Data were not collected for the historic usual care group so they were not included for analysis of this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From 3 Months in Hemoglobin A1c at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.16', 'spread': '.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.269', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Months 3 to 6', 'description': 'Average change in hemoglobin A1c from 3 months to 6 months for the intervention group.', 'unitOfMeasure': '% glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the intervention group who had hemoglobin A1c values available at time points of comparison were included. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Achieve Glycemic Targets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '.31', 'groupId': 'OG000'}, {'value': '.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Achieving glycemic target defined as reduction in hemoglobin A1c \\<7% by 3 months after baseline', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention group includes those participants who completed the study and had 3 month hemoglobin A1c values. Usual care is a historical comparative group.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Maintain Glycemic Targets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Maintaining glycemic target defined as maintaining a hemoglobin A1c \\<7% at 6 months for those who achieved this target at 3 months in the intervention group.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the intervention group who reached their target glycemic goal (hemoglobin A1c \\<7%) at 3 months and had hemoglobin A1c values available at 6 months. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diabetes Distress at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.47', 'spread': '.55', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'pValueComment': 'Reported p-value was calculated.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the intervention group who completed the study. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diabetes Distress at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.49', 'spread': '.57', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'pValueComment': 'Reported p-value was calculated.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All intervention participants who completed the study. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From 3 Months in Diabetes Distress at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.02', 'spread': '.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.647', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 to month 6', 'description': 'Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the intervention. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.'}, {'type': 'SECONDARY', 'title': 'Participant Acceptability of Insulin Dosing Support System for Insulin Titration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Participants rated their acceptability of My Dose Coach using a study-specific survey. Individual items are scored from 1 to 5; total scores are the average of all individual item scores; . Possible score range 1 to 5. The higher the score, the better the rating or acceptability of the insulin dosing support system.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the intervention who completed the study.'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction With Insulin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.6', 'spread': '10.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Diabetes Medication Systems Rating Questionnaire-Short Form, was also be used to inform patient acceptability and satisfaction with insulin. This questionnaire includes 20 items to assess convenience, negative events, interference, self-monitoring of blood glucose burden, efficacy, social burden, psychological well-being, treatment satisfaction and treatment preference. All items are scored 0 to 100. Composite score is calculated as means of completed items. Possible score range is 0 to 100. The higher the score, the higher the level of satisfaction.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the intervention. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Total number of hypoglycemic events where blood glucose \\<70mg/dl.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the intervention who completed the study. Did not collect on historic control group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Severe Hypoglycemic Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Severe hypoglycemic events were defined a hypoglycemic events that required assistance of another person to resuscitate because blood glucoses are too low to maintain consciousness.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the intervention who completed the study. Did not collect on historic control group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participant Use of My Dose Coach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'As reported across study period, up to 6 months', 'description': "Patient use of My Dose Coach app was track through the app's data analytics software platform. High app use was defined as logging in app \\>3days per week.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All intervention participants who completed the study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Technical Complaints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Number of technical complaints made by participants about My Dose Coach app', 'unitOfMeasure': 'Number of complaints', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in intervention.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Frequency of Escalation of Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Frequency of endocrinology and other medical visits beyond protocol will be used to assess escalation of care', 'unitOfMeasure': 'Number of visits', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the intervention. Data were not collected for the historic usual care group so they were not included for analysis for this outcome.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Type of Technical Complaints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Type of technical complaints made by participants about My Dose Coach app', 'unitOfMeasure': 'Type of complaints', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in intervention'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Type of Escalation of Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Type of endocrinology and other medical visits beyond protocol were used to assess escalation of care', 'unitOfMeasure': 'Type of escalation of care', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients enrolled in the intervention. Did not collect on historic control group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'My Dose Coach (Insulin Dosing Support App)', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}, {'id': 'FG001', 'title': 'Usual Care Group', 'description': 'A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Study paused to address technical issues related to the app. Participants removed from study .', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were identified at participating community-based primary care practices, diabetes outpatient clinics and hospital inpatient units.', 'preAssignmentDetails': 'Usual care is a historical comparison group, therefore usual care participants were not considered to be enrolled into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo.\n\nPatients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '9.7', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '9.8', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% glycated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Usual care participants were identified through retrospective chart review; they were not formally enrolled in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-29', 'size': 596112, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-19T14:13', 'hasProtocol': True}, {'date': '2021-08-26', 'size': 856430, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-19T14:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'Technical issues with app and prolonged recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2020-12-08', 'resultsFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-22', 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participant Use of My Dose Coach', 'timeFrame': 'As reported across study period, up to 6 months', 'description': "Patient use of My Dose Coach app was track through the app's data analytics software platform. High app use was defined as logging in app \\>3days per week."}, {'measure': 'Number of Technical Complaints', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Number of technical complaints made by participants about My Dose Coach app'}, {'measure': 'Frequency of Escalation of Care', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Frequency of endocrinology and other medical visits beyond protocol will be used to assess escalation of care'}, {'measure': 'Type of Technical Complaints', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Type of technical complaints made by participants about My Dose Coach app'}, {'measure': 'Type of Escalation of Care', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Type of endocrinology and other medical visits beyond protocol were used to assess escalation of care'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Glycemic Control at 3 Months', 'timeFrame': 'Baseline to 3 months', 'description': 'Average change in hemoglobin A1c from baseline to 3 months'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Blood Glucose at 3 Months', 'timeFrame': 'Baseline to 3 months', 'description': 'Change in fasting blood glucose from baseline to 3 months for the intervention group.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose at 6 Months', 'timeFrame': 'Baseline to 6 months', 'description': 'Change in fasting blood glucose from baseline to 6 months for the intervention group.'}, {'measure': 'Change From 3 Months in Fasting Blood Glucose at 6 Months', 'timeFrame': 'Months 3 to 6', 'description': 'Chang in fasting blood glucose from month 3 to 6 for the intervention group.'}, {'measure': 'Change From Baseline in Hemoglobin A1c at 6 Months', 'timeFrame': 'Baseline to 6 months', 'description': 'Average change in hemoglobin A1c from baseline to 6 months for the intervention group.'}, {'measure': 'Change From 3 Months in Hemoglobin A1c at 6 Months', 'timeFrame': 'Months 3 to 6', 'description': 'Average change in hemoglobin A1c from 3 months to 6 months for the intervention group.'}, {'measure': 'Proportion of Patients Who Achieve Glycemic Targets', 'timeFrame': '3 months', 'description': 'Achieving glycemic target defined as reduction in hemoglobin A1c \\<7% by 3 months after baseline'}, {'measure': 'Proportion of Patients Who Maintain Glycemic Targets', 'timeFrame': '6 months', 'description': 'Maintaining glycemic target defined as maintaining a hemoglobin A1c \\<7% at 6 months for those who achieved this target at 3 months in the intervention group.'}, {'measure': 'Change From Baseline in Diabetes Distress at 3 Months', 'timeFrame': 'Baseline to 3 months', 'description': 'Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.'}, {'measure': 'Change From Baseline in Diabetes Distress at 6 Months', 'timeFrame': 'Baseline to 6 months', 'description': 'Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.'}, {'measure': 'Change From 3 Months in Diabetes Distress at 6 Months', 'timeFrame': 'Month 3 to month 6', 'description': 'Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.'}, {'measure': 'Participant Acceptability of Insulin Dosing Support System for Insulin Titration', 'timeFrame': '3 months', 'description': 'Participants rated their acceptability of My Dose Coach using a study-specific survey. Individual items are scored from 1 to 5; total scores are the average of all individual item scores; . Possible score range 1 to 5. The higher the score, the better the rating or acceptability of the insulin dosing support system.'}, {'measure': 'Participant Satisfaction With Insulin Treatment', 'timeFrame': '6 months', 'description': 'The Diabetes Medication Systems Rating Questionnaire-Short Form, was also be used to inform patient acceptability and satisfaction with insulin. This questionnaire includes 20 items to assess convenience, negative events, interference, self-monitoring of blood glucose burden, efficacy, social burden, psychological well-being, treatment satisfaction and treatment preference. All items are scored 0 to 100. Composite score is calculated as means of completed items. Possible score range is 0 to 100. The higher the score, the higher the level of satisfaction.'}, {'measure': 'Number of Hypoglycemic Events', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Total number of hypoglycemic events where blood glucose \\<70mg/dl.'}, {'measure': 'Number of Participants Who Experienced Severe Hypoglycemic Events.', 'timeFrame': 'As reported across study period, up to 6 months', 'description': 'Severe hypoglycemic events were defined a hypoglycemic events that required assistance of another person to resuscitate because blood glucoses are too low to maintain consciousness.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Mobile application', 'Digital titration'], 'conditions': ['Diabetes Mellitus Type 2 - Insulin-Treated']}, 'referencesModule': {'references': [{'pmid': '15735199', 'type': 'RESULT', 'citation': 'Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.'}, {'pmid': '22228744', 'type': 'RESULT', 'citation': 'Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6.'}, {'pmid': '24673614', 'type': 'RESULT', 'citation': 'Peyrot M, Xu Y, Rubin RR. Development and validation of the Diabetes Medication System Rating Questionnaire-Short Form. Diabet Med. 2014 Oct;31(10):1237-44. doi: 10.1111/dme.12453. Epub 2014 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate an electronic application (app) designed to help people with type 2 diabetes (T2DM) adjust their insulin doses. The app is called My Dose Coach. This research study is being done in 2 phases. Specifically in Phase 1, the study is assessing the role of the My Dose Coach app in helping participants make insulin adjustments to get their blood glucoses to the target level that is planned for with the diabetes team, called the dosing or titration phase, when first starting insulin. In Phase 2, the study is assessing the role of the My Dose Coach app in helping participants keep blood glucoses in the target range, called the maintenance phase.', 'detailedDescription': 'Despite the increasing body of knowledge of diabetes treatment strategies, a majority of patients with T2DM are still in a persistent state of poor glycemic control and unable to meet target goals. Inertia surrounding insulin initiation and titration is a specific problem. Various approaches have been proposed to help overcome clinical inertia, including support of patient self-management, and education for both physicians and people with diabetes. Presently, paper-based guides are available in which clinicians/educators rely on to help their patients in determining and recording appropriate insulin doses. Unfortunately, this process often sets the stage for reluctance and fear of insulin initiation and delays titration with implications for long-term poor self-management and adherence. Therefore, Sanofi developed the My Dose Coach electronic app to assist with optimizing titration of basal insulins and supporting proper insulin maintenance. The primary objective of this two phase study is to demonstrate that patients who are trained on the My Dose Coach app to titrate insulin will have greater improvements in hemoglobin A1c and will be more likely to achieve glycemic control at three months as compared to usual care practice, and, for the intervention group only, those who do attain glycemic goals will be able to maintain glycemic control for an additional three months. The secondary objective of this study is to examine the feasibility of integrating digital solutions into clinical workflow and user acceptability of My Dose Coach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIntervention Group\n\n* Patient receiving care at a UPMC Diabetes Outpatient and/or Inpatient settings\n* Adult male and female patients 18 to 75 years old\n* HbA1c \\> 7.5%\n* Recommended to start self titration of basal insulin\n* Access to and able to use an iOS (Apple phone operating system) or Android enabled device and have reliable internet access\n* Willing and able to use the MDC app\n* Able to comprehend basic diabetes survival skills, signs and symptoms of hypoglycemia and treatment of BG\n\nUsual Care Group\n\n* Adult male and female patients 18 to 75 years old\n* HbA1c \\> 7.5%\n* Started on basal insulin in a UPMC Diabetes Outpatient facility within the past three years of study start\n* Has blood glucose data available in electronic medical records (EMR) (At least two HbA1c measurements corresponding to baseline and a subsequent time point after insulin titration)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Patients unwilling to use MDC app'}, 'identificationModule': {'nctId': 'NCT04678661', 'briefTitle': 'My Dose Coach Mobile App to Support Insulin Titration and Maintenance', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'My Dose Coach Titration and Maintenance in Patients With Type 2 Diabetes Mellitus on Basal Insulin', 'orgStudyIdInfo': {'id': 'STUDY20040308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'My Dose Coach (Insulin Dosing Support App)', 'description': 'Phase 1 Titration: Patients receive insulin therapy education from diabetes educator (DE). Plus, DE trains patients to use My Dose Coach (MDC) for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients are asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reach glycemic target are invited to Phase 2. Other patients are invited to continue titrating for another 3 months.\n\nPhase 2 Maintenance: At 3-mo clinic visit, an EP or DE trains patients the MDC Maintenance Module to support proper insulin dosing. Patients are asked to return for follow-up clinic visits at mo 6.\n\nPatients are surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.', 'interventionNames': ['Device: Smartphone application and web portal', 'Behavioral: Standard Insulin Therapy Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Group', 'description': 'A retrospective comparative group will be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group will be identified using data available in the electronic medical record system. Propensity score matching will be used to pair intervention and usual care participants during phase 1 of the study (baseline to 3 months).', 'interventionNames': ['Behavioral: Standard Insulin Therapy Education']}], 'interventions': [{'name': 'Smartphone application and web portal', 'type': 'DEVICE', 'otherNames': ['My Dose Coach'], 'description': "My Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. MDC is intended as an aid to the patient to provide dose suggestions based upon the HCP's independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient Instructions. The application uses the dose plan instructions provided by the patient's HCP to provide dose suggestions of once-daily long-acting basal insulin (i.e. basal insulin titration) that are based on the patient's Fasting Blood Glucose (FBG) as well as hypoglycemia occurrence.\n\nMDC includes a Maintenance Module designed to support patients in maintaining proper insulin dosingby enabling logging of administered doses of prescribed diabetes medications and BGM and providing dosing and measurement reminders.", 'armGroupLabels': ['My Dose Coach (Insulin Dosing Support App)']}, {'name': 'Standard Insulin Therapy Education', 'type': 'BEHAVIORAL', 'description': "Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.", 'armGroupLabels': ['My Dose Coach (Insulin Dosing Support App)', 'Usual Care Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Linda Siminerio, RN, PhD, CDE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'timeFrame': 'After the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.', 'ipdSharing': 'YES', 'description': 'A consent form used in enrolling participants will be posted.', 'accessCriteria': 'ICF will be added to Clinicaltrials.gov record.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linda Siminerio', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Linda Siminerio', 'investigatorAffiliation': 'University of Pittsburgh'}}}}