Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT05854069
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-29
First Post:
2023-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-05-09', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Data sharing during the intervention period', 'timeFrame': '6 months post-baseline', 'description': 'Number of data sharing relationships, between groups; more is better'}, {'measure': 'Satisfaction with data-sharing relationships', 'timeFrame': '6 months post-baseline', 'description': 'Satisfaction with data-sharing relationships assessed by CGM-Satisfaction Scale; higher scores are better'}], 'primaryOutcomes': [{'measure': 'CGM frequency of use during the intervention period', 'timeFrame': 'Baseline and 6 months post-baseline', 'description': 'Change in CGM frequency of use assessed by self-report on questionnaire; more frequent use/higher is better'}, {'measure': 'CGM frequency of use during the intervention period', 'timeFrame': 'Baseline and 6 months post-baseline', 'description': 'Change in CGM frequency of use assessed by objective CGM data (% of time; higher is better)'}, {'measure': 'Gaps in CGM use', 'timeFrame': '6 months post-baseline', 'description': 'Length of gaps in CGM use as assessed by objective CGM data (measured in number of consecutive days without CGM data; higher is worse)'}], 'secondaryOutcomes': [{'measure': 'CGM behavioral responses during the intervention period', 'timeFrame': 'Baseline and 6 months post-baseline', 'description': 'Change in frequency of making behavioral changes in response to CGM data assessed by self-report; higher scores indicate more frequent response (better)'}, {'measure': 'Barriers to CGM use during the intervention period', 'timeFrame': 'Baseline and 6 months post-baseline', 'description': 'Change in perceived influence of CGM on glycemic control scale assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse)'}, {'measure': 'Barriers to CGM use during the intervention period', 'timeFrame': 'Baseline and 6 months post-baseline', 'description': 'Change in perceived influence of CGM on social complications assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse)'}, {'measure': 'CGM satisfaction during the intervention period', 'timeFrame': 'Baseline and 6 months post-baseline', 'description': 'Change in CGM satisfaction assessed by Benefits of CGM scale; higher scores indicate more perceived benefits of CGM use (better)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Continuous glucose monitor', 'Social support', 'Goal setting', 'Diabetes distress', 'Hemoglobin A1c', 'Time in range', 'Emerging adults', 'Family support', 'Text message', 'Mobile health'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.', 'detailedDescription': 'FAMS (Family/friend Activation to Motivate Self-care) is a mobile phone-delivered intervention, based on Family Systems Theory, which helps adults with diabetes set behavioral goals and improve support received from friends and family for goal success. FAMS includes monthly phone coaching and text message support by FAMS coaches for the person with diabetes (PWD) and the option to enroll a support person (SP) to receive automated texts tailored to the self-care goals the person with T1D sets in coaching sessions. Adaptations specific to CGM include the option to set CGM use goals in coaching (and receive associated text support) and skill-building exercises during coaching to support data sharing relationships (e.g., establishing, setting and adjusting ground rules about communication).\n\nWithin the FAMS-T1D RCT (NCT05820477), we will test effects of FAMS-T1D on CGM use use relative to enhanced treatment as usual. We will evaluate effects on CGM use from baseline to post-intervention (6 months) as the primary endpoint. Study start date for the nested trial (NCT05854069) is the enrollment date of the first participant using a CGM. Since the goal of this trial is to assess effects of the adapted FAMS intervention on CGM use, the date participant CGM usage was confirmed is considered the enrollment date.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPERSONS WITH DIABETES\n\n* Ages 18-24\n* Have a diagnosis of T1D and has been taking insulin for at least one year\n* Comfortable sending and receiving texts\n* Can speak, read, and write in English\n* Meets one of the following two criteria: 1) has a most recent A1c value in the EHR that is 7.5% or higher (or missing) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2)\n* Using a continuous glucose monitor (CGM)\n\nSUPPORT PERSONS\n\n* Age 18 or older\n* Can speak, read, and write in English or Spanish\n* Comfortable sending and receiving texts\n\nExclusion Criteria:\n\nPERSONS WITH DIABETES\n\n* Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness)\n* Plans to live outside the country during the study period\n\nSUPPORT PERSONS\n\n* Shares a phone with the person with diabetes\n* Plans to live outside of the country during the study period'}, 'identificationModule': {'nctId': 'NCT05854069', 'briefTitle': 'Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '220847'}, 'secondaryIdInfos': [{'id': 'G-2203-05822', 'type': 'OTHER_GRANT', 'domain': 'The Leona M. and Harry B. Helmsley Charitable Trust'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FAMS-T1D', 'description': 'Participants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support persons will receive text messages that are tailored to the goal set by the person with type 1 diabetes.\n\nAll persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes.', 'interventionNames': ['Behavioral: FAMS-T1D', 'Behavioral: Digital resources for diabetes']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Digital resources for diabetes', 'description': 'All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes.', 'interventionNames': ['Behavioral: Digital resources for diabetes']}], 'interventions': [{'name': 'FAMS-T1D', 'type': 'BEHAVIORAL', 'otherNames': ['Family/friend Activation to Motivate Self-Care for those with Type 1 Diabetes'], 'description': 'FAMS-T1D involves monthly phone coaching that assists individuals in setting specific and time bound diabetes goals with automated text message support to the patient participant and less frequent automated text messages to their support person, if one is enrolled.\n\nBehavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly.', 'armGroupLabels': ['FAMS-T1D']}, {'name': 'Digital resources for diabetes', 'type': 'BEHAVIORAL', 'description': 'Quality digital resources about diabetes management provided upon enrollment and during the study.', 'armGroupLabels': ['Digital resources for diabetes', 'FAMS-T1D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later.', 'ipdSharing': 'YES', 'description': 'After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.', 'accessCriteria': 'Contact the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Leona M. and Harry B. Helmsley Charitable Trust', 'class': 'OTHER'}, {'name': 'University of Utah', 'class': 'OTHER'}, {'name': 'University of California, Merced', 'class': 'OTHER'}, {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Lindsay Mayberry', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}