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NCT Number: NCT06814184

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Health Family Medicine at Monument Square, New Brunswick, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Primary outcomes

  1. Glycemic control: glycated hemoglobin AIC

    Time frame: baseline, 3, 6, 9, and 12 months

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

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

    Time frame: baseline, 3, 6, 9, and 12 months

    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.

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

    Time frame: baseline, 3, 6, 9, and 12 months

    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.

Secondary outcomes

  1. Diabetes Knowledge Test 2 (23 iems) for knowledge change

    Time frame: baseline, 3, 6, 9, and 12 months

    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.

  2. Diabetes Empowerment Scale Short 28 items for self-efficacy change

    Time frame: baseline, 3, 6, 9, and 12 months

    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.

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

    Time frame: baseline, 3, 6, 9, and 12 months

    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.

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

    Time frame: baseline, 3, 6, 9, and 12 months

    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.

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

    Time frame: baseline, 3, 6, 9, and 12 months

    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.

  6. Summary of Diabetes Self-Care Activities Measure (11 items) for Self-management activity changes

    Time frame: baseline, 3, 6, 9, and 12 months

    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.

  7. Blood Glucose (BG) testing frequency change

    Time frame: baseline, 3, 6, 9, and 12 months

    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.

  8. Diabetes Numeracy Test short (15 items) for knowledge change

    Time frame: baseline, 3, 6, 9, and 12 months

    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.

Study contacts

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

Helen NC Chen, PhD

CONTACT

[email protected]

(908) 466-3953

Toya Williams, MPH

CONTACT

[email protected]

‭(732) 235-7380‬

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Acronym: virtual care

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 7, 2025
Registry last updated
Jul 2, 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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