Virtual Diabetes Care for Adults With Type 2 Diabetes on Medicaid and Insulin Therapy

NCT06814184 | Recruiting

• 1 other identifier: Pro2025000096
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This 12-month pilot tests a nurse-led, app-based intervention to improve diabetes self-management for Medicaid patients. It includes MyChart messaging to give education, phone help on problem-solving with clinicians, and using a diabetes app to track data. The study aims to enhance self-management behaviors through health technology.

Conditions

Type 2 Diabetes

Keywords

diabetes app; behavioral intervention; self-management; diabetes

Outcome Measures

Primary Outcomes (3)

• Glycemic control: glycated hemoglobin AIC

  Electronic health record extracted lab test drawn at baseline, 3, 6, 9, and 12 months

  baseline, 3, 6, 9, and 12 months

• Glycemic control - the rate of pre-prandial blood glucose readings in target range

  Home monitoring glucometer at baseline and diabetes app report containing blood glucose readings at home for 3, 6, 9, and 12 months. It is calculated from the number of BG that met the target divided by the total number of BG tested.

  baseline, 3, 6, 9, and 12 months

• Glycemic control - the rate of peak postprandial blood glucose reading in target range

  Blood glucose reading obtained from patient's home monitoring glucometer at baseline and diabetes app report containing blood glucose readings at home for 3, 6, 9, and 12 months. It is calculated from the number of BG that met the target divided by the total number of BG tested.

  baseline, 3, 6, 9, and 12 months

Secondary Outcomes (8)

• Diabetes Knowledge Test 2 (23 iems) for knowledge change

  baseline, 3, 6, 9, and 12 months

• Diabetes Empowerment Scale Short 28 items for self-efficacy change

  baseline, 3, 6, 9, and 12 months

• AHC Health-Related Social Needs Screening Tool (10 items) for Social Determinants of Health Change

  baseline, 3, 6, 9, and 12 months

• Brief Cope Inventory (28 items) for effective and ineffective ways to cope with stressful life events.

  baseline, 3, 6, 9, and 12 months

• Diabetes Distress Scale (17 items) for quality of life change

  baseline, 3, 6, 9, and 12 months

Study Arms (2)

Experimental with intervention

EXPERIMENTAL

Intervention starts at enrollment

Behavioral: app-based nurse-led virtual diabetes care

Delayed Intervention

OTHER

Intervention delivery 3 months after enrollment

Behavioral: app-based nurse-led virtual diabetes care

Interventions

app-based nurse-led virtual diabetes care BEHAVIORAL

A nurse-led, app-based behavioral intervention consisting of (1) education via MyChart messaging, (2) problem solving with an action plan via phone, and (3) remote patient monitoring via mySugr app to identify the need to adjust treatment

Delayed Intervention; Experimental with intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A1C \>7 for age 18-64, A1C\>8 for age 65 or older within 12 months prior baseline
• A1C\>7 for age 18-64, A1c\>8 for age 65 or older at baseline
• Medicaid recipient or dual Medicaid and Medicare recipient
• Age 18 or older
• Type 2 diabetes
• On insulin therapy
• Owning and using Android or iOS smartphone for at least 6 months
• English proficiency
• Adequate vision to read text messages on their current smartphone
• Smartphone use proficiency. Smartphone proficiency will be self-reported and determined by telephone as the ability to use a smartphone in ways other than emailing, texting, and making phone calls.

You may not qualify if:

• Pregnancy
• Patients with cognitive impairment who will be screened with the Six-Item Screener to Identify Cognitive Impairment Among Potential Research Subjects.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Rutgers Health Family Medicine at Monument Square

New Brunswick, New Jersey, 08901, United States

RECRUITING

University Medical Group General Internal Medicine

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Helen NC Chen, PhD

  Rutgers School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen NC Chen, PhD

CONTACT

(908) 466-3953; helen.nc.chen@rutgers.edu

Toya Williams, MPH

CONTACT

‭(732) 235-7380‬; toya.williams@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Both clinics collect baseline at the same time for both clinics. Masking participants that we tell participants that we will reach out to when intervention rolls out. Clinic 2 will roll out 3 months later than Clinic 1.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD RN CRNP

Model Details: Clinic 1 starts enrollment and intervention on 4/1/2026, while Clinic 2 starts enrollment but intervention starts on 7/1/2026. We cannot deliver intervention the same time parallel step-wedge, give two clinics intervention can't deliver intervention same time

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 7, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)