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Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes

A Multiphase Optimization Strategy to Enhance Diabetes Management Interventions for Patients With Uncontrolled Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Community Health Worker (CHW) addressing social determinants of health (SDOH) and diabetes and medicine misperceptions (ON), or 4. both MTM Optimizing Medication Therapy and CHW Addressing SDOH and diabetes and medicine misperceptions for 6 months."
  • "CHW support will also address diabetes and medicine misperceptions by completing a series of phone calls with the subject to provide information about managing diabetes and medicines, discuss cultural health misperceptions, share medication adherence experiences, and provide social support over the phone."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ways to help adults with type 2 diabetes manage their medicines and diabetes. Participants will get usual care, extra medicine support from a pharmacist, help with life challenges from a community health worker, or both types of support.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18–90 years old and have type 2 diabetes.
  • Speak and understand English or Spanish.
  • Take at least one diabetes medicine by mouth or by injection.
  • Have an HbA1c of 7.5% or higher on a test done at the visit. This test measures average blood sugar.
  • Will live in the study area for the whole study.
  • Have access to a phone during the study.
  • Are willing to attend all introduction and training sessions.

Who can't join

  • Have a caregiver who makes most decisions about your diabetes self-care.
  • Are in another program that helps with lifestyle changes or taking medicines as directed.
  • Received medication therapy management (MTM), or similar help managing medicines, in the past 6 months.
  • Are pregnant or plan to become pregnant in the next 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

WI