NCT07689877

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
56mo left

Started Aug 2026

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

4.6 years

First QC Date

July 1, 2026

Last Update Submit

July 1, 2026

Conditions

DiabetesDiabetes Type 2

Outcome Measures

Primary Outcomes (3)

  • 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).

    Baseline, 16 weeks and 32 weeks

  • 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.

    Baseline, 16 weeks and 32 weeks

  • 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.

    Baseline, 16 weeks and 32 weeks

Secondary Outcomes (4)

  • Mean score Revised Summary of Diabetes Self-Care Activities (SDSCA)

    Baseline, 16 weeks and 32 weeks

  • Mean score Diabetes Management Self-Efficacy Scale

    Baseline, 16 weeks and 32 weeks

  • Mean score Diabetes Distress Scale

    Baseline, 16 weeks and 32 weeks

  • Mean score Diabetes Quality of Life Brief Clinical Inventory

    Baseline, 16 weeks and 32 weeks

Study Arms (3)

Group A: Continuous Glucose Monitoring (CGM)-only

NO INTERVENTION

Continuous Glucose Monitoring (CGM)-only

Group B: Integrated Digital Health (IDH) platform without provider engagement

EXPERIMENTAL

IDH without provider engagement

Behavioral: Integrated Digital Health (IDH) platform

Group C: Integrated Digital Health (IDH) platform with provider engagement

EXPERIMENTAL

IDH with provider engagement

Behavioral: Integrated Digital Health (IDH) platformBehavioral: Provider engagement

Interventions

Integrated Digital Health (IDH) platformBEHAVIORAL

CGM, wearable for physical activity and sleep, food scan/log

Group B: Integrated Digital Health (IDH) platform without provider engagementGroup C: Integrated Digital Health (IDH) platform with provider engagement
Provider engagementBEHAVIORAL

Weekly feedback through the IDH platform plus monthly video calls

Group C: Integrated Digital Health (IDH) platform with provider engagement

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of T2D for at least one year
  • recent 3 month-HbA1c, 8-11%
  • ownership of a smartphone
  • English or Spanish speaking.

You may not qualify if:

  • 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®+).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Nursing

New Haven, Connecticut, 06477, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN

    Yale University School of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soohyun Nam, PhD

CONTACT

203-737-2822soohyun.nam@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 8, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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

Locations

US(1)