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

July 1, 2026 updated by: Yale University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06477
        • Yale School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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®+).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Behavioral: Integrated Digital Health (IDH) platform
CGM, wearable for physical activity and sleep, food scan/log
Experimental: Group C: Integrated Digital Health (IDH) platform with provider engagement
IDH with provider engagement
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Hemoglobin A1c (HbA1c)
Time Frame: 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).
Baseline, 16 weeks and 32 weeks
Mean Glucose Variability (Coefficient of Variation [%CV])
Time Frame: 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.
Baseline, 16 weeks and 32 weeks
Percentage of glucose readings with Time in Range (TIR)
Time Frame: 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.
Baseline, 16 weeks and 32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean score Revised Summary of Diabetes Self-Care Activities (SDSCA)
Time Frame: 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.
Baseline, 16 weeks and 32 weeks
Mean score Diabetes Management Self-Efficacy Scale
Time Frame: 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.
Baseline, 16 weeks and 32 weeks
Mean score Diabetes Distress Scale
Time Frame: 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.
Baseline, 16 weeks and 32 weeks
Mean score Diabetes Quality of Life Brief Clinical Inventory
Time Frame: 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.
Baseline, 16 weeks and 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN, Yale University School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000043169
  • 1R01DK149276-01 (Other Grant/Funding Number: NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified study data will be shared per NIH data sharing policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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