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

NCT ID: NCT06814184

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-02

Study Completion Date

2028-04-03

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
Both clinics collect baseline at the same time for both clinics. Masking participants that we tell participants that we will reach out to when intervention rolls out. Clinic 2 will roll out 3 months later than Clinic 1.

Study Groups

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Experimental with intervention

Intervention starts at enrollment

Group Type EXPERIMENTAL

app-based nurse-led virtual diabetes care

Intervention Type 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

Delayed Intervention

Intervention delivery 3 months after enrollment

Group Type OTHER

app-based nurse-led virtual diabetes care

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Helen NC Chen PhD, FNP

PHD RN CRNP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helen NC Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers School of Nursing

Central Contacts

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Helen NC Chen, PhD

Role: CONTACT

(908) 466-3953

Olga Jarrin Montaner, PhD

Role: CONTACT

(860) 455-6372

Other Identifiers

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K99NR020377

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2025000096

Identifier Type: -

Identifier Source: org_study_id

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