Glucose, Understanding, Integrated Digital Health, and Engagement (GUIDE) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Integrated Digital Health (IDH) platform, Provider engagement.
- Who it may be relevant to
- Registry conditions: Diabetes, Diabetes Type 2. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Behavioral Integrated Digital Health (IDH) platform
CGM, wearable for physical activity and sleep, food scan/log - Behavioral Provider engagement
Weekly feedback through the IDH platform plus monthly video calls
Primary outcome measures
- Mean Hemoglobin A1c (HbA1c) [Time frame: Baseline, 16 weeks and 32 weeks]
- Mean Glucose Variability (Coefficient of Variation [%CV]) [Time frame: Baseline, 16 weeks and 32 weeks]
- Percentage of glucose readings with Time in Range (TIR) [Time frame: Baseline, 16 weeks and 32 weeks]
Secondary outcome measures (4)
- Mean score Revised Summary of Diabetes Self-Care Activities (SDSCA) [Time frame: Baseline, 16 weeks and 32 weeks]
- Mean score Diabetes Management Self-Efficacy Scale [Time frame: Baseline, 16 weeks and 32 weeks]
- Mean score Diabetes Distress Scale [Time frame: Baseline, 16 weeks and 32 weeks]
- Mean score Diabetes Quality of Life Brief Clinical Inventory [Time frame: Baseline, 16 weeks and 32 weeks]
Eligibility criteria
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®+).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Yale School of Nursing — New Haven
Identifiers
NCT: NCT07689877 · 2000043169 · 1R01DK149276-01