A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia

April 5, 2026 updated by: Rozalina G. McCoy, Mayo Clinic

Community Paramedicine Program to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia

This pilot study will assess the feasibility, preliminary efficacy, and acceptability of the Diabetes-REM (Rescue, Engagement, and Management), a comprehensive patient-centered intervention delivered by community paramedics in the community setting to improve diabetes self-management, prevent recurrent hypoglycemia, reduce diabetes distress, and improve quality of life among adults in southeast Minnesota who have experienced severe hypoglycemia.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Severe hypoglycemia in the management of diabetes is associated with high morbidity, mortality, psychological distress, and impaired quality of life. Recognizing, actively engaging, and providing comprehensive care to at-risk patients to address hypoglycemia risk factors and enhance diabetes self-management skills may help reduce the frequency/severity of hypoglycemic events, alleviate diabetes distress, and improve quality of life.

This study will assess the feasibility, preliminary efficacy, and acceptability of Diabetes-REM (Rescue, Engagement, and Management) to improve diabetes self-management among adults in southeast Minnesota who have experienced severe hypoglycemia. The D-REM program is a one month long intervention delivered by community paramedics at the patient's home. Community paramedics are trained in disease prevention, management, and wellness in addition to emergency response.

Using a two-group parallel design, 150 adults will be randomly assigned to 1 month of Diabetes-REM or usual care. Both groups will receive education materials on hypoglycemia/diabetes and clinical/community resources. One group, comprised of 75 patients, will also be cared for by community paramedics at no cost to them. Study measures will include surveys (completed by participants in both arms) and an interview (completed by a subset of participants in the arm receiving community paramedic support).

Eligible individuals who decline participation in the D-REM trial will then be offered participation in a one-time interview conducted via audio technology to understand their experiences with hypoglycemia and its prevention.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 18 years of age or older.
  • Experience of level 3 hypoglycemia
  • Type 1 or type 2 diabetes.
  • Paneled to a Mayo Clinic or Mayo Clinic Health System practice.
  • Able to provide informed consent.
  • Community-dwelling in either Freeborn, Mower, Olmsted, Steele, or Wabasha county.

Identifying patients who experienced level 3 hypoglycemia:

  1. Treated by Mayo Clinic Ambulance for hypoglycemia
  2. Treated in Mayo Clinic ED or hospital for hypoglycemia.
  3. Patients who have a diagnosis of hypoglycemia on their electronic health record problem list.
  4. Patients who experienced level 3 hypoglycemia and are referred to the community paramedic service by their healthcare provider.

Exclusion Criteria:

  • Under 18 years of age.
  • Cognitive impairment precluding informed consent.
  • Lack of conversational English skills.
  • Residency in a long-term care facility.
  • Enrolled in hospice.
  • Enrolled in a care coordination or disease management program.
  • Advanced or terminal illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community Paramedic (CP) program and Education Materials
Subjects will receive CP home visits and telephone calls for 1 month, along with printed diabetes education materials and a resource guide for contacting their diabetes care team in addition to usual care.
Other: Community Paramedic Program
Patients will be seen for a 1-hr in person evaluation and follow-up will be determined on an individual basis based on patient need. During each visit, CPs will perform health status and social determinants of health assessments, physical exam, medication review/counseling, and goal setting/review.
Other: Education Material
Participants will be provided with a diabetes resource card, which will provide a list of clinic and community-based diabetes resources, along with a diabetes education packet, which will include information on diabetes self-management, healthy diet, physical activity, glucose self-monitoring, and hypoglycemia.
Active Comparator: Usual Care and Education Materials
Subjects will receive printed diabetes education materials and a resource guide for contacting their diabetes care team in addition to usual care.
Other: Education Material
Participants will be provided with a diabetes resource card, which will provide a list of clinic and community-based diabetes resources, along with a diabetes education packet, which will include information on diabetes self-management, healthy diet, physical activity, glucose self-monitoring, and hypoglycemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Self-Management
Time Frame: Baseline, 1 month, 4 months
Change in Diabetes Self-Management Questionnaire (DSMQ) score
Baseline, 1 month, 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported hypoglycemia
Time Frame: Baseline, 1 month, 4 months
Self-reported level 1 and level 2 hypoglycemia
Baseline, 1 month, 4 months
Health-related Quality of life (EQ-5D)
Time Frame: Baseline, 1 month, 4 months
Change in EQ-5D score
Baseline, 1 month, 4 months
Diabetes distress
Time Frame: Baseline, 1 month, 4 months
Change in the Diabetes Distress Scale
Baseline, 1 month, 4 months
Glycemic control
Time Frame: Baseline, 4 months
Hemoglobin A1c level
Baseline, 4 months
Qualitative experience with hypoglycemia and its prevention
Time Frame: Baseline (one-time interview only)
Eligible individuals who decline participation in the D-REM trial will be offered participation in a one-time interview conducted via audio technology to understand their experiences with hypoglycemia and its prevention. These interviews will be qualitatively analyzed.
Baseline (one-time interview only)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Rozalina G McCoy, MD, MS, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-006799
  • R03DK127010 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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