Virtual Diabetes Care for Low Socioeconomic Status Adults With Type 2 Diabetes on Insulin Therapy

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT06814184
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

This 12-month pilot tests a nurse-led, app-based intervention to improve diabetes self-management for low-socioeconomic status patients. It includes MyChart messing 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.

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 low-socioeconomic status 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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-01
• Study First Submitted QC: 2025-02-01
• Study First Posted: 2025-02-07
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Study Start: 2026-01-02
• Primary Completion: 2028-01-03
• Study Completion: 2028-04-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• A1C>8% within 12 months prior baseline
• A1C>8% at baseline
• Low-SES (defined as a Medicaid recipient or dual Medicaid and Medicare recipient or self-reported low income based on National Poverty Guidelines)
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycemic control: glycated hemoglobin AIC	baseline, 3, 6, 9, and 12 months	Electronic health record extracted lab test drawn at baseline, 3, 6, 9, and 12 months
Glycemic control - the rate of pre-prandial blood glucose readings in target range	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.
Glycemic control - the rate of peak postprandial blood glucose reading in target range	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 Outcome Measures

Name	Time	Method
Diabetes Knowledge Test 2 (23 iems) for knowledge change	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.
Diabetes Empowerment Scale Short 28 items for self-efficacy change	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.
AHC Health-Related Social Needs Screening Tool (10 items) for Social Determinants of Health Change	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.
Jalowiec Coping Scale 40 items for coping style and effectiveness change	baseline, 3, 6, 9, and 12 months	The scale evaluates both problem-oriented and affective-oriented coping strategies, providing insights into how individuals manage the challenges associated with diabetes. 40 is minimal, 200 is max. Higher score indicate a greater use of coping strategies, which generally suggests better coping and potentially better outcomes in managing diabetes.
Diabetes Distress Scale (17 items) for quality of life change	baseline, 3, 6, 9, and 12 months	It measures the emotional stress specific to diabetes management. 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 score indicates greater levels of diabetes distress, which generally suggests worse outcomes in terms of emotional well-being and diabetes management.
Summary of Diabetes Self-Care Activities Measure (11 items) for Self-management activity changes	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.
BG testing frequency change	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.
Diabetes Numeracy Test short (15 items) for knowledge change	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.