Diabetes, Diabetes Type 2
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALIntegrated Digital Health (IDH) platform
CGM, wearable for physical activity and sleep, food scan/log
BEHAVIORALProvider engagement
Weekly feedback through the IDH platform plus monthly video calls
Sponsors
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of T2D for at least one year * recent 3 month-HbA1c, 8-11% * ownership of a smartphone * English or Spanish speaking.
Exclusion criteria
* pregnant * not available or willing to use CGM or study device/platform * serious medical conditions or active thought disorders (e.g., terminal cancer, schizophrenia) 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®+).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Hemoglobin A1c (HbA1c) | Baseline, 16 weeks and 32 weeks | 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). |
| Mean Glucose Variability (Coefficient of Variation [%CV]) | Baseline, 16 weeks and 32 weeks | 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. |
| Percentage of glucose readings with Time in Range (TIR) | Baseline, 16 weeks and 32 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean score Revised Summary of Diabetes Self-Care Activities (SDSCA) | Baseline, 16 weeks and 32 weeks | 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. |
| Mean score Diabetes Management Self-Efficacy Scale | Baseline, 16 weeks and 32 weeks | 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. |
| Mean score Diabetes Distress Scale | Baseline, 16 weeks and 32 weeks | 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. |
| Mean score Diabetes Quality of Life Brief Clinical Inventory | Baseline, 16 weeks and 32 weeks | 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. |
Countries
United States
Contacts
CONTACTSoohyun Nam, PhD
PRINCIPAL_INVESTIGATORSoohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN
Yale University School of Nursing
Outcome results
None listed