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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorRutgers, The State University of New Jersey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental with interventionExperimental treatment 1 intervention
Group B: Delayed InterventionOther 1 intervention

Trial outcomes

Primary outcomes

1

Glycemic control: glycated hemoglobin AIC

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

Time frame
baseline, 3, 6, 9, and 12 months
2

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.

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

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.

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

Secondary outcomes

1

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.

Time frame
baseline, 3, 6, 9, and 12 months
2

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.

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

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.

Time frame
baseline, 3, 6, 9, and 12 months
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator