Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK149276-01 | Other Grant/Funding Number | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Continuous Glucose Monitoring (CGM)-only | No Intervention | Continuous Glucose Monitoring (CGM)-only | |
| Group B: Integrated Digital Health (IDH) platform without provider engagement | Experimental | IDH without provider engagement |
|
| Group C: Integrated Digital Health (IDH) platform with provider engagement | Experimental | IDH with provider engagement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated Digital Health (IDH) platform | Behavioral | CGM, wearable for physical activity and sleep, food scan/log |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | Baseline, 16 weeks and 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 16 weeks and 32 weeks |
Not provided
Inclusion Criteria:
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®+).
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soohyun Nam, PhD | Contact | 203-737-2822 | soohyun.nam@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN | Yale University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Nursing | New Haven | Connecticut | 06477 | United States |
De-identified study data will be shared per NIH data sharing policy.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Provider engagement | Behavioral | Weekly feedback through the IDH platform plus monthly video calls |
|
| 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. |
| 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. | 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. | Baseline, 16 weeks and 32 weeks |