Recruiting

Diabetes Management

Sponsor:

University of Wisconsin, Madison

Code:

NCT05912647

Conditions

Diabetes

Diabetes Type 2

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MTM

CHW

Study Details

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

Study ID

NCT05912647

Start date

Feb 3, 2024

Status verified date

May, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

376 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Usual Care

experimental: Medication Therapy Management (MTM)

experimental: Community Health Worker (CHW)

experimental: MTM + CHW

Interventions

MTM

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.

CHW

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.

Primary outcome measure

  • Change in mean hemoglobin A1c score [ Time Frame: Baseline to 6 months ]
  • Change in mean hemoglobin A1c score [ Time Frame: Baseline to 12 months ]

Central Contacts and Locations

Central contacts

Martha Maurer

608-265-2662mamaurer@wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Martha Maurer

608-265-2662mamaurer@wisc.edu

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jul 23, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-07-23.