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Led by University of Wisconsin, Madison · Updated on 2026-07-23
376
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to find the best ways to improve pharmacy-related care for adults with type 2 diabetes who have uncontrolled blood sugar levels. The study evaluates different types of support, including usual care, pharmacist-led medication management, support from community health workers, and a combination of both, to see which approach helps people better manage their diabetes and use their medicines effectively. Participants will be randomly assigned to one of four groups for six months usual care only medication therapy management MTM with a pharmacist, which includes at least five sessions over six months community health worker CHW support involving a detailed assessment of social challenges and multiple phone calls to address diabetes beliefs or both MTM and CHW support combined. The CHW sessions include a comprehensive two-hour in-person assessment and ongoing phone support. During the study, participants will be monitored for changes in their hemoglobin A1c levels at six and twelve months to assess blood sugar control. Medication adherence will also be measured by refill data and adherence scales at these time points. Participants will attend scheduled sessions with pharmacists and community health workers, and researchers will track their progress through phone calls, assessments, and questionnaires throughout the study period.
CONDITIONS
Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes
M
Martha Maurer
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University of Wisconsin, Madison
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Medication Therapy Management support | Usual Care (no intervention) | Community Health Worker support | Combined MTM and CHW support | Pharmacist or CHW‑led community care |
|---|---|---|---|---|---|
| What it is | Pharmacist‑led medication therapy management including one 60‑minute session plus four 30‑minute follow‑ups | The usual diabetes management without added MTM or CHW support | Community health worker support with one ~30‑minute phone call, one in‑person 2‑hour visit, and multiple 10–30‑minute follow‑up calls | Combined MTM plus CHW sessions as per the MTM and CHW schedules | Community‑based diabetes self‑management models using pharmacists or CHWs to support glucose control |
| Role in trial | Assigned to pharmacist MTM intervention | Control arm receiving standard diabetes care | Assigned to CHW behavioral support intervention | Assigned to both MTM and CHW support | Reflects non‑trial community support strategies participants might access outside the study |
| Primary use | Improve medication use and glucose control via structured pharmacist support | Manage diabetes without study‑provided behavioral support | Provide behavioral support and address life‑barriers to diabetes self‑care via CHWs | Combine medication management and behavioral support for better glycemic control | Support self‑management in community settings via pharmacist or CHW programs |
| How it is given or performed | One 60‑minute pharmacist session initially (in person or phone), plus four 30‑minute follow‑up calls | Participants receive their usual diabetes care with no additional study sessions | One ~30‑minute call, one in‑person 2‑hour assessment, plus multiple 10–30‑minute CHW follow‑up calls | Participants receive both MTM sessions and CHW contacts as specified above | Community programs deliver pharmacist or CHW support via tailored sessions over time |
| Evidence status | Pharmacist‑led MTM has been shown to improve adherence and lower HbA1c in people with diabetes | Used as reference standard within the trial; no external evidence | CHW interventions reduce HbA1c by about 0.5 percentage points versus usual care in type 2 diabetes | Combination may offer added benefit beyond single‑agent support although evidence is limited | Community‑based pharmacist or CHW programs broadly improve glycemic control and self‑management |
| Important risks | No notable risks reported for pharmacist MTM interventions | No additional risk evidence beyond standard care | No significant risks reported for CHW behavioral support | Likely low risk combining MTM and CHW, but lacking specific safety data | Community support models are generally safe and non‑invasive |
| Important limitations | Focuses only on medication adherence, may not address broader self‑management challenges | Does not include added behavioral or medication support | May not affect medication adherence directly; focuses on behavioral and social support | Combination complexity may affect scalability and added benefit is unproven | Program models vary by setting and resources, outcomes may differ across communities |
| Patient impact | Pharmacist MTM improves medication adherence and may lead to HbA1c reduction based on existing evidence | Baseline management without added support—no measured change yet | CHW support leads to meaningful reductions in HbA1c (around 0.5%) and boosts self‑management | Combination may offer enhanced impact but evidence is not yet established | Community models show improved self‑care behaviors and glycemic control in real‑world settings |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive usual care or are assigned to receive medication therapy management with a pharmacist, community health worker support, or both for six months.
Multiple sessions with pharmacists and community health workers over six months
Duration - Up to 12 months
Researchers assess changes in blood sugar control and medication adherence at 6 and 12 months after starting the study.
Assessments at 6 and 12 months
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
4
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Olayinka O Shiyanbola, Martha A Maurer, Megan E Piper...
https://pubmed.ncbi.nlm.nih.gov/39761827/University of Wisconsin, Madison
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
