Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes

NCT05912647 | Recruiting DMC

• 4 other identifiers: 2023-07801R01DK136690-01PHARM/PHARMACYProtocol Version 5/23/25
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to learn about the best way to enhance pharmacy-related care for diabetes self-management. This research is being done because we want to improve use of medicines and diabetes management among adults with type 2 diabetes and find out which of type of support may improve diabetes self-management for adults. Participants will be assigned to one of 4 groups, and will either:

• receive care as usual; or,
• receive added medicine management support from a pharmacist; or,
• receive support from a Community Health Worker (CHW) to address life challenges; or,
• receive both the pharmacist medicine management and the CHW support

Conditions

Diabetes; Diabetes Type 2

Outcome Measures

Primary Outcomes (2)

• Change in mean hemoglobin A1c score

  HbA1c will be measured, and the mean change will be compared across arms

  Baseline to 6 months

• Change in mean hemoglobin A1c score

  HbA1c will be measured, and the mean change will be compared across arms

  Baseline to 12 months

Secondary Outcomes (2)

• Change in medication adherence - medication refill

  6 months and 12 months

• Mean scores on the Adherence to Refills and Medications Scale for Diabetes

  6 months and 12 months

Study Arms (4)

Usual Care

NO INTERVENTION

Medication Therapy Management (MTM)

EXPERIMENTAL

Behavioral: MTM

Community Health Worker (CHW)

EXPERIMENTAL

Behavioral: CHW

MTM + CHW

EXPERIMENTAL

Behavioral: MTM; Behavioral: CHW

Interventions

CHW BEHAVIORAL

Participants will receive support from a Community Health Worker (CHW) to address life challenges that might be affecting their health and diabetes and to discuss diabetes beliefs and concerns. This will involve one \~30-minute phone call with the CHW to discuss needs and a 2-hour session with the CHW in-person for a comprehensive assessment. Participants will also receive \~10, 15 to 30-minute calls from the CHW to discuss diabetes beliefs and concerns.

Community Health Worker (CHW); MTM + CHW

MTM BEHAVIORAL

Participants will receive added medicine management support from a pharmacist. This will involve one 60-minute session with the pharmacist either in-person or over the phone and at least four 30-minute follow-up sessions with the pharmacist over the phone.

MTM + CHW; Medication Therapy Management (MTM)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ages 18-90 with diagnosed type 2 diabetes who speak and understand English or Spanish.
• Taking at least one oral or injectable diabetes medication
• HbA1c ≥ 7.5% based on point of care test.
• Will reside in the geographical area throughout the study period.
• Have access to a phone during the study period.
• Willing to attend all orientation/training sessions.

You may not qualify if:

• Having a caregiver who is the main decision maker in self-management.
• Participating in another lifestyle, or medication adherence program.
• Participated in standard MTM/MTM-related intervention in the last 6 months.
• Women who are pregnant or plan to get pregnant in the next 6 months.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Michelle Chui, PharmD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha Maurer

CONTACT

608-265-2662; mamaurer@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: February 3, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)