Virtual Diabetes Care for Adults With Type 2 Diabetes on Medicaid and Insulin Therapy (virtual care)

Nurse-led App Intervention to Improve Glycemic Control in Patients With Insulin-treated Type 2 Diabetes on Medicaid

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: app-based nurse-led virtual diabetes care

Detailed Description

Guided by the Self- and Family Management Framework, which specifies facilitators and barriers to self- management behaviors, this project tests strategies for delivering virtual diabetes care to help Medicaid patients and clinicians use health information technology to support self-management behaviors. It is a 12-month pilot nurse-led, app-based behavioral intervention consisting of three evidence-based interventions: (1) education on A1C results and goal-setting via MyChart, the Epic electronic health record's patient portal; (2) a problem-solving action plan developed collaboratively by clinicians and patients; and (3) remote monitoring via mySugr, a top- rated diabetes app, to track blood glucose and identify the need for treatment adjustments.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen NC Chen, PhD; Phone Number: (908) 466-3953; Email: helen.nc.chen@rutgers.edu
• Study Contact Backup: Name: Toya Williams, MPH; Phone Number: ‭(732) 235-7380‬; Email: toya.williams@rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Health Family Medicine at Monument Square
      • Contact: Medical Director; Phone Number: 732-235-8993; Email: clarkec@rwjms.rutgers.edu
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • University Medical Group General Internal Medicine
      • Contact: Shirin Hastings; Phone Number: 732-908-1437; Email: hastinse@rwjms.rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental with intervention; Intervention starts at enrollment	Behavioral: app-based nurse-led virtual diabetes care; 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
Other: Delayed Intervention; Intervention delivery 3 months after enrollment	Behavioral: app-based nurse-led virtual diabetes care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Knowledge Test 2 (23 iems) for knowledge change	This scale assesses the knowledge of individuals regarding diabetes management and self-care. 0 is minimal and 23 is maximal. Higher is better outcome reflecting high knowledge.	baseline, 3, 6, 9, and 12 months
Diabetes Empowerment Scale Short 28 items for self-efficacy change	The DES-28 has been validated and is considered a reliable tool for assessing the psychosocial aspects of diabetes management, making it useful for various educational and psychosocial interventions related to diabetes. 28 is minimal, 140 is max. Higher is better outcome, reflecting greater empowerment and self-efficacy in managing diabetes.	baseline, 3, 6, 9, and 12 months
AHC Health-Related Social Needs Screening Tool (10 items) for Social Determinants of Health Change	It help healthcare providers identifies the social needs of their patients, which can inform interventions and resource allocation. 0 is minimal, 10 is max. Higher score is greater number of identified health-related social needs, which may suggest worse outcomes in terms of social determinants of health.	baseline, 3, 6, 9, and 12 months
Summary of Diabetes Self-Care Activities Measure (11 items) for Self-management activity changes	It is a reliable and valid tool for evaluating diabetes self-management behaviors and is useful in both research and clinical settings. 0 is minimal indicating no self-care activities performed, 11 is max indicating all self-care activities performed. Higher score indicate Measure consists of 11 items that assess various aspects of diabetes self-management.	baseline, 3, 6, 9, and 12 months
Diabetes Numeracy Test short (15 items) for knowledge change	This test assesses diabetes-related numeracy skills that are essential for effective self-management of diabetes, such as interpreting blood glucose readings and calculating carbohydrate intake. 0-15, 0 is minimal with no correct answer, 15 is max. Higher is better outcome reflecting higher numeracy.	baseline, 3, 6, 9, and 12 months
Brief Cope Inventory (28 items) for effective and ineffective ways to cope with stressful life events.	The Brief Coping Inventory is a 28-item measure that assesses 14 distinct coping strategies, with two items representing each strategy. It provides insight into how individuals manage challenges related to diabetes and general life stressors. Each item is rated on a 4-point scale ranging from 1 ("not at all") to 4 ("a lot"). Scores for each coping strategy range from 2 to 8, with higher scores indicating greater use of that specific coping style. The total score for the full inventory ranges from 28 to 112, with higher overall scores reflecting a greater reliance on coping strategies across domains.	baseline, 3, 6, 9, and 12 months
Diabetes Distress Scale (17 items) for quality of life change	Measures emotional distress related to managing diabetes, with scores for each item ranging from 1 ("not a problem") to 6 ("a very serious problem"). It is a valuable tool for identifying patients who may need additional support in managing the emotional burdens associated with diabetes. 17 is minimal, 102 is max. Higher scores indicate greater diabetes-related distress, which is generally considered worse for overall well-being and diabetes management. Scores are typically categorized as little/no distress, moderate distress, or high distress to guide interventions.	baseline, 3, 6, 9, and 12 months
Blood Glucose (BG) testing frequency change	The number of blood glucose readings obtained from patient's home monitoring glucometer at baseline and the number of blood glucose readings listed in the diabetes app report at home for 3, 6, 9, and 12 months.	baseline, 3, 6, 9, and 12 months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Helen NC Chen, PhD, Rutgers School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 1, 2025
• First Submitted That Met QC Criteria: February 1, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; behavioral intervention; self-management; diabetes app
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: Pro2025000096; K99NR020377 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared. Each participant will be given a unique study identification number that will be used on all study forms and data files. Each participant's identifying data will be separated from the study data. All data will be de-identified with a participant code number. The code linking a participant to their code number will be maintained in a separate file on a secure server at Rutgers (e.g., Microsoft Teams, Box).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No