Glucose, Understanding, Integrated Digital Health, and Engagement (GUIDE) Study

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07689877
Status
Not Yet Recruiting

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Conditions

  • Diabetes
  • Diabetes Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Integrated Digital Health (IDH) platform — BEHAVIORAL
    CGM, wearable for physical activity and sleep, food scan/log
  • Provider engagement — BEHAVIORAL
    Weekly feedback through the IDH platform plus monthly video calls

Study Details

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.

Key Dates

First listed
Jul 8, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Group A: Continuous Glucose Monitoring (CGM)-only
    Continuous Glucose Monitoring (CGM)-only
  • Experimental: Group B: Integrated Digital Health (IDH) platform without provider engagement
    IDH without provider engagement
  • Experimental: Group C: Integrated Digital Health (IDH) platform with provider engagement
    IDH with provider engagement

Primary Outcome Measure

Mean Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 16 weeks and 32 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale School of NursingNew HavenConnecticut06477-

Find similar trials in New Haven, CT

By research site
Yale School of Nursing· New Haven, CT

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