Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes

NCT07181304 | Not Yet Recruiting

• 2 other identifiers: IRB-3000153277-25-ICTSPC-410
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will include a type 1 hybrid effectiveness implementation study to evaluate the effectiveness of the PROMOTE (peer support plus remote patient monitoring) program among Black adults with uncontrolled type 2 diabetes recruited from local primary care practices in Jefferson County, Alabama. Additionally, a mixed methods evaluation to characterize the contextual factors relevant to implementation of PROMOTE using Practical Robust Implementation Science Model (PRISM) will be conducted.

Conditions

Type 2 Diabetes

Keywords

Peer support; Remote patient monitoring

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c (A1C)

  Change in A1C value at 6-months compared to baseline. Lab values will be extracted from electronic health record. Per the American Diabetes Association (ADA) Standards of Care, A1C is recommended to be checked quarterly for patients with type 2 diabetes, whose A1C is not at target level (i.e. the eligibility criteria for this study sample).

  Baseline, 6-months

Secondary Outcomes (3)

• Change in blood pressure

  Baseline, 6-months

• Change in Low Density Lipoprotein (LDL)

  Baseline, 6-months

• Change in Body Mass Index (BMI)

  Baseline, 6-months

Study Arms (2)

PROMOTE

EXPERIMENTAL

Behavioral: PROMOTE; Behavioral: DSMES

Control

ACTIVE COMPARATOR

Behavioral: DSMES

Interventions

PROMOTE BEHAVIORAL

PROMOTE components includes 1) peer support, 2) remote patient monitoring of blood glucose (RPM), and 3) integration with clinical care. 1. Peer support delivered by community health workers focused on -- assistance in applying diabetes self-management in daily life, emotional and social support, linkage to clinical care, and ongoing, as-needed support. CHWs visits will include: one-on-one in-person visit, then weekly phone calls for 3 months, then monthly calls for 3 months. 2. RPM team will supply the device and supplies to participants. Data is transmitted electronically to the RPM team through broadband connectivity. Protocols have been developed for research projects; participants will be instructed to monitor blood glucose up to four times a day, based on medication regimen. Levels will be monitored 8 a.m. to 5 p.m. M-F. 3. A monthly report of peer support activities and RPM data will be sent to participants' primary care providers.

PROMOTE

DSMES BEHAVIORAL

Diabetes Self-Management Education and Support delivered virtually.

Control; PROMOTE

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 years or older
• Black race (self-reported)
• Diagnosis of type 2 diabetes
• Uncontrolled A1C \>8%
• Receipt of care at one of the study sites
• Speaks and reads in English

You may not qualify if:

• Limited English proficiency
• Currently pregnancy
• Non-community dwelling.
• Speaks and reads in English

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Diabetes Association: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Caroline Presley, MD

CONTACT

12059347609; capresley@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL