Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-01-03 @ 12:42 AM
Study NCT ID:
NCT03809858
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2019-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects will be randomized to the sequence of completion in a 1:1 ratio. All subject will collect data throughout the study with half of them using the Klue App during the first 6 weeks and half using the Klue App during the second 6 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-18', 'studyFirstSubmitDate': '2019-01-11', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of missed meal boluses', 'timeFrame': 'During the two weeks prior to each visit', 'description': 'The change in the number of missed meal boluses'}], 'secondaryOutcomes': [{'measure': 'Number of missed meal boluses as a measure of attenuation to the alerts', 'timeFrame': '6 weeks', 'description': 'The change in the number of missed meal boluses as a measure of attenuation to the alerts'}, {'measure': 'Number of missed meal boluses as a measure of attenuation to the alerts', 'timeFrame': '12 weeks', 'description': 'The change in the number of missed meal boluses as a measure of attenuation to the alerts'}, {'measure': 'Change in Hemoglobin A1c Levels', 'timeFrame': '3 months', 'description': 'Change in Hemoglobin A1c Levels'}, {'measure': 'Time in range 70-180 mg/dL', 'timeFrame': '6 weeks', 'description': 'Time in range 70-180 mg/dL as measured by CGM'}, {'measure': 'Time in range 70-180 mg/dL', 'timeFrame': '12 weeks', 'description': 'Time in range 70-180 mg/dL as measured by CGM'}, {'measure': 'Percent time <70 mg/dL mean glucose', 'timeFrame': '6 weeks', 'description': 'Percent time \\<70 mg/dL mean glucose as measured by CGM'}, {'measure': 'Percent time <70 mg/dL mean glucose', 'timeFrame': '12 weeks', 'description': 'Percent time \\<70 mg/dL mean glucose as measured by CGM'}, {'measure': 'Glucose Coefficient of Variation', 'timeFrame': '6 weeks', 'description': 'Glucose (as measured by CGM) Coefficient of Variation'}, {'measure': 'Glucose Coefficient of Variation', 'timeFrame': '12 weeks', 'description': 'Glucose (as measured by CGM) Coefficient of Variation'}, {'measure': 'Total daily insulin dose', 'timeFrame': '6 weeks', 'description': 'Total daily insulin dose'}, {'measure': 'Total daily insulin dose', 'timeFrame': '12 weeks', 'description': 'Total daily insulin dose'}, {'measure': 'Number of meal bolus injections each day', 'timeFrame': '6 weeks', 'description': 'Number of meal bolus injections each day'}, {'measure': 'Number of meal bolus injections each day', 'timeFrame': '12 weeks', 'description': 'Number of meal bolus injections each day'}, {'measure': 'Number of total bolus injections each day', 'timeFrame': '6 weeks', 'description': 'Number of total bolus injections each day'}, {'measure': 'Number of total bolus injections each day', 'timeFrame': '12 weeks', 'description': 'Number of total bolus injections each day'}, {'measure': 'Total daily basal insulin', 'timeFrame': '6 weeks', 'description': 'Total daily basal insulin'}, {'measure': 'Total daily basal insulin', 'timeFrame': '12 weeks', 'description': 'Total daily basal insulin'}, {'measure': 'Accuracy of Klue in detecting meals', 'timeFrame': '3 months', 'description': 'Accuracy of Klue in detecting meals (true positive and false positive rates)'}, {'measure': 'User satisfaction of Klue', 'timeFrame': '3 months', 'description': 'User satisfaction of Klue'}, {'measure': 'Diabetes-Specific Attitudes about Technology (DSAT) Scores', 'timeFrame': '3 months', 'description': 'DSAT Scores (Scaled from "Strongly Disagree" to "Strongly Agree" in relation to attitudes related to technology in diabetes treatment)'}, {'measure': 'Diabetes Distress Scale (DDS) Scores', 'timeFrame': '3 months', 'description': 'DDS Scores (Scaled from "Not a Problem" to "A Very Serious Problem" in relation to feelings/mood related to diabetes)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Klue', 'Meal bolus', 'Bolus reminder'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '14993580', 'type': 'BACKGROUND', 'citation': 'Burdick J, Chase HP, Slover RH, Knievel K, Scrimgeour L, Maniatis AK, Klingensmith GJ. Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy. Pediatrics. 2004 Mar;113(3 Pt 1):e221-4. doi: 10.1542/peds.113.3.e221.'}, {'pmid': '19175898', 'type': 'BACKGROUND', 'citation': 'Olinder AL, Kernell A, Smide B. Missed bolus doses: devastating for metabolic control in CSII-treated adolescents with type 1 diabetes. Pediatr Diabetes. 2009 Apr;10(2):142-8. doi: 10.1111/j.1399-5448.2008.00462.x. Epub 2008 Oct 24.'}, {'pmid': '21466646', 'type': 'BACKGROUND', 'citation': "O'Connell MA, Donath S, Cameron FJ. Poor adherence to integral daily tasks limits the efficacy of CSII in youth. Pediatr Diabetes. 2011 Sep;12(6):556-9. doi: 10.1111/j.1399-5448.2010.00740.x. Epub 2011 Apr 6."}, {'pmid': '27234809', 'type': 'BACKGROUND', 'citation': 'Naranjo D, Tanenbaum ML, Iturralde E, Hood KK. Diabetes Technology: Uptake, Outcomes, Barriers, and the Intersection With Distress. J Diabetes Sci Technol. 2016 Jun 28;10(4):852-8. doi: 10.1177/1932296816650900. Print 2016 Jul.'}]}, 'descriptionModule': {'briefSummary': 'This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and over\n* Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM\n* Willing to wear a CGM at least 70% of the time while in the study\n* Willing to wear an Apple watch on their dominant hand while awake\n* Missing or late in giving at least four food boluses in the previous 2 weeks\n* Understanding and willingness to follow the protocol and sign informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.\n* Current treatment for a seizure disorder\n* Inpatient psychiatric treatment in the past 6 months\n\nSubject may participate in another trial if it is approved by the investigators of both trials.'}, 'identificationModule': {'nctId': 'NCT03809858', 'briefTitle': 'Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses', 'orgStudyIdInfo': {'id': '180034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Klue App Use then Usual Care', 'description': 'Subjects will use the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will discontinue Klue App use and will continue the final 6 weeks without the product.', 'interventionNames': ['Other: Klue App']}, {'type': 'EXPERIMENTAL', 'label': 'Usual Care then Klue App Use', 'description': 'Subjects will begin the study without using the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will begin the use of the Klue App and will continue the final 6 weeks with the product.', 'interventionNames': ['Other: Klue App']}], 'interventions': [{'name': 'Klue App', 'type': 'OTHER', 'description': 'The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.', 'armGroupLabels': ['Klue App Use then Usual Care', 'Usual Care then Klue App Use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Marc Breton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no current plan to share individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Klue, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marc Breton', 'investigatorAffiliation': 'University of Virginia'}}}}