An interventional study of Integrated Digital Health (IDH) platform and Provider engagement in Diabetes and Diabetes Type 2, sponsored by Yale University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Yale University · Not applicable, Interventional, and Supportive care
The purpose of this study is to evaluate whether an Integrated Digital Health (IDH) intervention with and without healthcare provider engagement, improves glycemic control and diabetes-related outcomes among adults with Type 2 diabetes. The study will also assess the feasibility of integrating this approach into routine primary care to support personalized, data-informed diabetes management.
Participants will complete a total of three study visits: a baseline visit (which includes consent, screening, and enrollment procedures), a 16-week follow-up visit, and a 32-week follow-up visit. Each study visit is expected to last approximately 30 minutes. In addition, participants will complete study surveys throughout the study period, which are expected to require approximately 30-40 minutes per survey. Depending on study group assignment, participants may also use study devices and mobile applications to track health behaviors and/or participate in telehealth visits with a healthcare provider. The frequency and duration of these activities will vary by study group.
Exclusion Criteria:
In addition to the self-report of the HbA1c within the past 3 months, potential participants will be screened with a point-of-care (POC) HbA1c (A1CNow®+).
Continuous Glucose Monitoring (CGM)-only
IDH without provider engagement
Behavioral: Integrated Digital Health (IDH) platform
IDH with provider engagement
Behavioral: Integrated Digital Health (IDH) platform · Behavioral: Provider engagement
CGM, wearable for physical activity and sleep, food scan/log
Weekly feedback through the IDH platform plus monthly video calls
Mean Hemoglobin A1c (HbA1c)
HbA1c in milligrams per deciliter (mg/dL) will be measured using blood testing conducted according to the standardized procedures of the National Glycohemoglobin Standardization Program (NGSP).
Time frame: Baseline, 16 weeks and 32 weeks
Mean Glucose Variability (Coefficient of Variation [%CV])
Glucose variability will be derived from continuous glucose monitoring (CGM) data and calculated as the coefficient of variation (CV = standard deviation/mean glucose × 100). This measure reflects intra- and inter-day fluctuations in glucose levels. Consistent with consensus recommendations, a CV ≤36% is considered stable glucose variability.
Time frame: Baseline, 16 weeks and 32 weeks
Percentage of glucose readings with Time in Range (TIR)
TIR will be derived from CGM data and calculated as the percentage of glucose readings and time per day within the target glucose range of 70-180 mg/dL (3.9-10.0 mmol/L). Consistent with consensus recommendations, a TIR ≥70% is considered an indicator of optimal glycemic management.
Time frame: Baseline, 16 weeks and 32 weeks
Mean score Revised Summary of Diabetes Self-Care Activities (SDSCA)
12-item validated measure evaluating adherence to diabetes self-care behaviors, including diet, physical activity, blood glucose monitoring, and medication adherence. Total score range 0-7 with higher scores indicating more adherence.
Time frame: Baseline, 16 weeks and 32 weeks
Mean score Diabetes Management Self-Efficacy Scale
20-item validated instrument measuring participants' confidence in their ability to manage diabetes-related tasks and challenges. Total score range 1-5 with higher scores indicating a greater level of self-efficacy.
Time frame: Baseline, 16 weeks and 32 weeks
Mean score Diabetes Distress Scale
17-item scale which assesses distress associated with diabetes management, healthcare providers, emotional burden, and interpersonal concerns. Total score range 1-6 with higher scores indicating more distress.
Time frame: Baseline, 16 weeks and 32 weeks
Mean score Diabetes Quality of Life Brief Clinical Inventory
15-item validated instrument evaluating the impact of diabetes on physical, emotional, and social well-being. Total score range 1-5 with higher scores indicating a more negative perspective of the condition.
Time frame: Baseline, 16 weeks and 32 weeks
Plan to share: Yes — De-identified study data will be shared per NIH data sharing policy.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Yale University