Actively Recruiting
A Multiphase Optimization Strategy to Enhance Diabetes Management Interventions for Patients With Uncontrolled Diabetes
Led by University of Wisconsin, Madison · Updated on 2026-06-01
376
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying ways to improve pharmacy-related care for adults with type 2 diabetes who have uncontrolled blood sugar. The goal is to find out which type of support can best help people manage their diabetes and use their medicines more effectively. This study is focused on adults aged 18 to 90 who are currently taking at least one diabetes medication and have elevated hemoglobin A1c levels. Participants will be randomly assigned to one of four groups for six months: usual care, added medicine management support from a pharmacist, support from a Community Health Worker (CHW) addressing life challenges and diabetes beliefs, or both the pharmacist and CHW support together. Those in the pharmacist groups will have a series of medication therapy sessions totaling five meetings over six months, while those in the CHW groups will receive an initial comprehensive assessment and ongoing phone support to address social challenges and diabetes concerns. During the study, participants will attend orientation and training sessions and have access to a phone for ongoing communication. Researchers will monitor changes in hemoglobin A1c at six and twelve months to see how well blood sugar is controlled. They will also track medication adherence through refill records and patient questionnaires. The study will last long enough to observe these outcomes and understand how different support approaches affect diabetes management.
CONDITIONS
Brief Title
Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women ages 18 to 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% or higher 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 and training sessions
You will not qualify if you...
- Having a caregiver who is the main decision maker in self-management
- Participating in another lifestyle or medication adherence program
- Participated in standard MTM or MTM-related intervention in the last 6 months
- Women who are pregnant or plan to get pregnant in the next 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or phone)
Duration - 6 months
Participants receive usual care for diabetes management. Depending on randomization, participants may receive Medication Therapy Management (MTM) involving sessions with a pharmacist and/or support from a Community Health Worker (CHW) to address social determinants of health and diabetes beliefs.
At least five MTM sessions and multiple CHW phone calls over 6 months
Duration - 6 months
Participants are monitored for changes in diabetes management and medication adherence after the treatment period ends.
Assessments at 12 months post-baseline
Trial Site Locations
Total: 1 location
1
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
M
Martha Maurer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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