Glucose, Understanding, Integrated Digital Health, and Engagement (GUIDE) Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of T2D for at least one year
recent 3 month-HbA1c, 8-11%
ownership of a smartphone
English or Spanish speaking.
Disqualifiers
pregnant
not available or willing to use CGM or study device/platform
serious medical conditions or active thought disorders (e.g., terminal cancer, schizophrenia)
Trial design
Design model
Parallel
Treatments tested in this trial
Integrated Digital Health (IDH) platform
BehavioralCGM, wearable for physical activity and sleep, food scan/log
Provider engagement
BehavioralWeekly feedback through the IDH platform plus monthly video calls
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Group A: Continuous Glucose Monitoring (CGM)-onlyNo intervention 0 interventions
Group B: Group B: Integrated Digital Health (IDH) platform without provider engagementExperimental treatment 1 intervention
Group C: Group C: Integrated Digital Health (IDH) platform with provider engagementExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeks3
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov
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