Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-02-26 @ 11:15 AM
Study NCT ID:
NCT03224234
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2017-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'geumpie@emory.edu', 'phone': '404-251-8957', 'title': 'Dr. Umpierrez', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 8, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 13, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Pilot: Insulclock With Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Pilot: Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglicemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toe injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain of muscular etiology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non serious work related muscular injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CHF shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure Readmission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical Procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Insulin Injection Irregularities.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'OG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}, {'id': 'OG002', 'title': 'Pilot: Insulclock With Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'OG003', 'title': 'Pilot: Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.22', 'spread': '25.12', 'groupId': 'OG000'}, {'value': '23.10', 'spread': '26.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 through week 24.', 'description': 'Number of insulin injection irregularities (omission, mistiming and dosing) will be registered on the Insulclock device, and data will be retrieved during each clinic visit to monitor treatment adherence.', 'unitOfMeasure': 'irregularities', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were collected as a part of main phase of the study only.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Insulclock Device Malfunctions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'OG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}, {'id': 'OG002', 'title': 'Pilot: Insulclock With Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'OG003', 'title': 'Pilot:Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 weeks', 'description': 'Number of participants experiencing Insulclock device malfunctions are reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were collected as a part the pilot phase. Data on Insulclock device malfunctions were collected, it was planned to improve all issues by the time the main phase of the study started.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'OG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}, {'id': 'OG002', 'title': 'Pilot: Insulclock Without Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'OG003', 'title': 'Pilot: Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.45', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '15.18', 'spread': '3.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The amplitude of the score on the DTSQc gives the degree of change in satisfaction while the direction (positive or negative) will provide guidance on the preference of one device over the other. DTSQc contains eight items scored on 7-point scales; scores range from +3 = much more satisfied now to -3 = much less satisfied now, with 0 (midpoint), representing no change.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were collected as a part of main phase of the study only.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Related Quality of Life (DRQoL) Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'OG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}, {'id': 'OG002', 'title': 'Pilot: Insulclock Without Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'OG003', 'title': 'Pilot: Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}], 'timeFrame': 'Baseline, 24 weeks', 'description': 'DRQoL is a composite score, consisting of a standardized and unweighted Insulin Treatment Experience Questionnaire Score (ITEQ), and Problem Areas in Diabetes (PAID) questionnaire score. ITEQ includes 7 domains: leisure activities (4 items), psychological barriers (2 items), handling (5 items), diabetes control (6 items), dependence (5 items), weight control (3 items), sleep (2 items); + 1 additional item assigned to assess overall satisfaction with current insulin therapy regimen. The PAID contains 20 items that describe negative emotions related to diabetes commonly experienced by patients with diabetes. Each question has five possible answers with a value from 0 to 4, with 0 representing "no problem" and 4 "a serious problem". The scores are added up and multiplied by 1.25, generating a total score between 0 - 100.', 'reportingStatus': 'POSTED', 'populationDescription': 'The questionnaire was considered originally for use in the study, but no replies were received in a timely manner from the companies in charge of providing licensing for it. Therefore, data was not collected.'}, {'type': 'SECONDARY', 'title': 'Change in Mean HbA1c.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'OG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}, {'id': 'OG002', 'title': 'Pilot: Insulclock Without Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'OG003', 'title': 'Pilot: Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The test is limited to a three-month average because the lifespan of a red blood cell is four months (120 days). Change in mean HbA1cas will be measure and recorded to monitor glycemic control.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were collected as a part of main phase of the study only.'}, {'type': 'SECONDARY', 'title': 'Number of Episodes of Hypoglycemia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'OG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}, {'id': 'OG002', 'title': 'Pilot: Insulclock Without Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'OG003', 'title': 'Pilot: Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 through week 24.', 'description': 'Number of episodes of hypoglycemia will be recorded. For this study, symptomatic hypoglycemia is defined as an event with typical symptoms (i.e., sweating, palpitation, and feeling of hunger) with or without confirmation by plasma glucose \\<54 mg/dl (3.9 mmol/L).', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were collected as a part of main phase of the study only.'}, {'type': 'SECONDARY', 'title': 'Number of Episodes of Severe Hypoglycemia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'OG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}, {'id': 'OG002', 'title': 'Pilot: Insulclock Without Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'OG003', 'title': 'Pilot: Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 through week 24.', 'description': 'Number of episodes of severe hypoglycemia will be recorded.Severe hypoglycemia is defined as episodes necessitating assistance and associated with measured plasma glucose \\< 40 mg/dl (2.2 mmol/L), or with prompt recovery after administration of carbohydrates, glucagon, or other resuscitative actions.', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were collected as a part of main phase of the study only.'}, {'type': 'SECONDARY', 'title': 'Change in Daily Fasting Glucose Profile Averages.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'OG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}, {'id': 'OG002', 'title': 'Pilot: Insulclock Without Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'OG003', 'title': 'Pilot: Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}], 'classes': [{'categories': [{'measurements': [{'value': '142.24', 'spread': '32', 'groupId': 'OG000'}, {'value': '146.54', 'spread': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 through week 24.', 'description': 'Daily fasting glucose profile averages will be recorded to monitor glycemic control.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were collected as a part of main phase of the study only.'}, {'type': 'SECONDARY', 'title': 'Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'OG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}, {'id': 'OG002', 'title': 'Pilot: Insulclock Without Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'OG003', 'title': 'Pilot: Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}], 'timeFrame': '3 to 5 days prior to randomization, up to 24 weeks.', 'description': 'SMBG refers to home blood glucose testing for people with diabetes. 7-point SMBG profile include fasting, before meals, 2 hours after meals, and bedtime.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was only collected at baseline, but not at other visits, therefore it was not possible to assess any change, and it was excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'OG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}, {'id': 'OG002', 'title': 'Pilot: Insulclock Without Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'OG003', 'title': 'Pilot: Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}], 'timeFrame': 'Baseline, 24 weeks.', 'description': 'The DQLCTQ-R is a 57-item scale that comprises 8 dimensions: physical function, energy/fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility, and frequency of symptoms.', 'reportingStatus': 'POSTED', 'populationDescription': 'The questionnaire was considered originally, but no replies were received in a timely manner from the company in charge of providing licensing for it. Therefore, data were not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'FG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}], 'periods': [{'title': 'Main Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': 'Pilot', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study consented 121 participants. The study team realized that changes needed to be done for the protocol to be efficient. The first 28 candidates were consented for "pilot" data, ten of them were screen failures, 18 were randomized. Data on Insulclock device malfunctions were collected, it was planned to improve all issues by the time the main phase of the study started. 93 subjects were consented for the main study, 13 were screen failures, and 80 subjects were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulclock With Feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.'}, {'id': 'BG001', 'title': 'Insulclock Without Feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.\n\nInsulclock without feedback: Not feedback on insulin administration.'}, {'id': 'BG002', 'title': 'Pilot: Insulclock With Feedback (Group A)', 'description': 'Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'BG003', 'title': 'Pilot:Insulclock Without Feedback (Group B)', 'description': 'Participants use the Insulclock, but will not receive feedback on insulin administration.\n\nDuring the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device.'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Main study phase', 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-01', 'size': 1267492, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-18T15:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2017-07-19', 'resultsFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-04', 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Insulin Injection Irregularities.', 'timeFrame': 'Week 0 through week 24.', 'description': 'Number of insulin injection irregularities (omission, mistiming and dosing) will be registered on the Insulclock device, and data will be retrieved during each clinic visit to monitor treatment adherence.'}, {'measure': 'Number of Participants Experiencing Insulclock Device Malfunctions', 'timeFrame': 'Up to 12 weeks', 'description': 'Number of participants experiencing Insulclock device malfunctions are reported'}], 'secondaryOutcomes': [{'measure': 'Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The amplitude of the score on the DTSQc gives the degree of change in satisfaction while the direction (positive or negative) will provide guidance on the preference of one device over the other. DTSQc contains eight items scored on 7-point scales; scores range from +3 = much more satisfied now to -3 = much less satisfied now, with 0 (midpoint), representing no change.'}, {'measure': 'Change in Diabetes Related Quality of Life (DRQoL) Scores.', 'timeFrame': 'Baseline, 24 weeks', 'description': 'DRQoL is a composite score, consisting of a standardized and unweighted Insulin Treatment Experience Questionnaire Score (ITEQ), and Problem Areas in Diabetes (PAID) questionnaire score. ITEQ includes 7 domains: leisure activities (4 items), psychological barriers (2 items), handling (5 items), diabetes control (6 items), dependence (5 items), weight control (3 items), sleep (2 items); + 1 additional item assigned to assess overall satisfaction with current insulin therapy regimen. The PAID contains 20 items that describe negative emotions related to diabetes commonly experienced by patients with diabetes. Each question has five possible answers with a value from 0 to 4, with 0 representing "no problem" and 4 "a serious problem". The scores are added up and multiplied by 1.25, generating a total score between 0 - 100.'}, {'measure': 'Change in Mean HbA1c.', 'timeFrame': 'Baseline, 24 weeks', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The test is limited to a three-month average because the lifespan of a red blood cell is four months (120 days). Change in mean HbA1cas will be measure and recorded to monitor glycemic control.'}, {'measure': 'Number of Episodes of Hypoglycemia.', 'timeFrame': 'Week 0 through week 24.', 'description': 'Number of episodes of hypoglycemia will be recorded. For this study, symptomatic hypoglycemia is defined as an event with typical symptoms (i.e., sweating, palpitation, and feeling of hunger) with or without confirmation by plasma glucose \\<54 mg/dl (3.9 mmol/L).'}, {'measure': 'Number of Episodes of Severe Hypoglycemia.', 'timeFrame': 'Week 0 through week 24.', 'description': 'Number of episodes of severe hypoglycemia will be recorded.Severe hypoglycemia is defined as episodes necessitating assistance and associated with measured plasma glucose \\< 40 mg/dl (2.2 mmol/L), or with prompt recovery after administration of carbohydrates, glucagon, or other resuscitative actions.'}, {'measure': 'Change in Daily Fasting Glucose Profile Averages.', 'timeFrame': 'Week 0 through week 24.', 'description': 'Daily fasting glucose profile averages will be recorded to monitor glycemic control.'}, {'measure': 'Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile.', 'timeFrame': '3 to 5 days prior to randomization, up to 24 weeks.', 'description': 'SMBG refers to home blood glucose testing for people with diabetes. 7-point SMBG profile include fasting, before meals, 2 hours after meals, and bedtime.'}, {'measure': 'Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score', 'timeFrame': 'Baseline, 24 weeks.', 'description': 'The DQLCTQ-R is a 57-item scale that comprises 8 dimensions: physical function, energy/fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility, and frequency of symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Uncontrolled Type 2 Diabetes', 'Insulclock', 'Electronic device', 'Alarm system'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming.', 'detailedDescription': "Diabetes is arguably the most urgent healthcare challenge of the 21st century. Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming. The Insulclock's real time memory and alert system are likely to improve treatment adherence, patient's satisfaction, and quality of life measures, which may improve glycemic control in insulin treated patients with Type 2 Diabetes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 18 to 80 years\n* Diagnosis of T2D\n* Screening HbA1c ≥ 7.5% to ≤ 11%\n* Continuous treatment with one or more oral antidiabetic agents, for at least 2 months\n* Continuous treatment with daily basal insulin (NPH, glargine U100 or detemir), for at least 2 months, (insulin dose ≤0.5U/Kg/day)\n* If patients are on combination therapy of basal insulin and GLP1-RA, the dose of GLP-1 RA should be stable for the past three months.\n* Owns a smartphone - Apple iPhone, Samsung Galaxy models\n* Signed, informed consent and HIPAA documentation\n* Subjects' ability to self-administer insulin, use the device and complete subject reported outcomes instruments\n* Subjects' ability \\& willingness to adhere to and be compliant with study protocol\n\nExclusion Criteria:\n\n* Refusal or inability to give informed consent to participate in the study\n* Subject is currently taking or was treated with glargine U300 insulin, degludec, insulin dose greater than 0.5 U/kg/day during the previous three months\n* Subject treated with prandial insulin or premixed formulations during the previous three months\n* Impaired renal function as shown by, but not limited to, eGFR \\< 30 ml/min.\n* Muscle weakness or hemiparesis related to previous stroke or myelopathy resulting in incoordination, muscle weakness and inability to use pen device for insulin administration\n* History of diabetic ketoacidosis during the previous 6 months\n* Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times the upper limit of the normal range\n* History of hypoglycemia unawareness\n* Pregnancy or lactation\n* Known hypersensitivity to insulin glargine or any of the components\n* Any malignancy within the last 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ\n* Current drug addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years\n* Diagnosis of dementia\n* Severe gastrointestinal diseases including gastroparesis\n* Cardiac status NYHA III-IV\n* Acute infection\n* Patients on or planning to receive long term oral or injectable steroid treatment for greater than 10 days\n* Patient schedule to undergo general surgery during the next 6 months\n* Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study"}, 'identificationModule': {'nctId': 'NCT03224234', 'briefTitle': 'A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'IRB00094393'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulclock with feedback (Group A)', 'description': 'Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm.', 'interventionNames': ['Device: Insulclock with feedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulclock without feedback (Group B)', 'description': 'Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm.', 'interventionNames': ['Device: Insulclock without feedback']}], 'interventions': [{'name': 'Insulclock with feedback', 'type': 'DEVICE', 'description': 'Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.', 'armGroupLabels': ['Insulclock with feedback (Group A)']}, {'name': 'Insulclock without feedback', 'type': 'DEVICE', 'description': 'Not feedback on insulin administration.', 'armGroupLabels': ['Insulclock without feedback (Group B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Clinic, Emory University Hospital (non-CRN), Emory University Hospital Clinical Research Network, Emory University Hospital Midtown, Grady Health System (non-CRN)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Guillermo Umpierrez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Insulcloud S.L.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Guillermo Umpierrez, MD', 'investigatorAffiliation': 'Emory University'}}}}