Clinical trial NCT06814184: Virtual Diabetes Care for Low Socioeconomic Status Adults With Type 2 Diabetes on Insulin Therapy
Official title: Improving Glycemic Control Among Underserved Patients With Insulin-treated Type 2 Diabetes Through Nurse-led, App-based Behavioral Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes app
behavioral intervention
self-management
diabetes
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2025-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinic 1 starts enrollment and intervention on 1/2/2026, while Clinic 2 starts enrollment but intervention starts on 4/1/2026. We cannot deliver intervention the same time rallel step-wedge, give two clinics intervention can't deliver intervention same time
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycemic control: glycated hemoglobin AIC
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Glycemic control - the rate of pre-prandial blood glucose readings in target range
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Glycemic control - the rate of peak postprandial blood glucose reading in target range
timeFrame: baseline, 3, 6, 9, and 12 months
Secondary outcomes:
measure: Diabetes Knowledge Test 2 (23 iems) for knowledge change
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Diabetes Empowerment Scale Short 28 items for self-efficacy change
timeFrame: baseline, 3, 6, 9, and 12 months
measure: AHC Health-Related Social Needs Screening Tool (10 items) for Social Determinants of Health Change
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Jalowiec Coping Scale 40 items for coping style and effectiveness change
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Diabetes Distress Scale (17 items) for quality of life change
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Summary of Diabetes Self-Care Activities Measure (11 items) for Self-management activity changes
timeFrame: baseline, 3, 6, 9, and 12 months
measure: BG testing frequency change
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Diabetes Numeracy Test short (15 items) for knowledge change
timeFrame: baseline, 3, 6, 9, and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Rutgers School of Nursing
name: Helen NC Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: