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NCT Number: NCT07689877

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Nursing

New Haven, Connecticut, 06477, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®+).

Treatment and study plan

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

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Soohyun Nam, PhD

CONTACT

[email protected]

203-737-2822

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Acronym: GUIDE

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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