A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia

NCT04874532 | Suspended

• 2 other identifiers: 20-006799R03DK127010
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoglycemia; Diabetes; Diabetes Type 1; Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

• Diabetes Self-Management

  Change in Diabetes Self-Management Questionnaire (DSMQ) score

  Baseline, 1 month, 4 months

Secondary Outcomes (5)

• Self-reported hypoglycemia

  Baseline, 1 month, 4 months

• Health-related Quality of life (EQ-5D)

  Baseline, 1 month, 4 months

• Diabetes distress

  Baseline, 1 month, 4 months

• Glycemic control

  Baseline, 4 months

• Qualitative experience with hypoglycemia and its prevention

  Baseline (one-time interview only)

Study Arms (2)

Community Paramedic (CP) program and Education Materials

EXPERIMENTAL

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; Other: Education Material

Usual Care and Education Materials

ACTIVE COMPARATOR

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

Interventions

Community Paramedic Program OTHER

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.

Community Paramedic (CP) program and Education Materials

Education Material OTHER

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.

Community Paramedic (CP) program and Education Materials; Usual Care and Education Materials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Bhagra S, Ducharme-Smith AL, Juntunen MB, Liedl CP, Golembiewski EH, Sundt WJ, Krpata TS, Lampman MA, Espinoza AL, McCoy RR. Diabetes rescue, engagement, and management (D-REM) for hypoglycemia: Clinical trial protocol of a community paramedic program to improve diabetes management among adults with severe hypoglycemia. PLoS One. 2025 Jun 9;20(6):e0322177. doi: 10.1371/journal.pone.0322177. eCollection 2025.

  PMID: 40489473 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rozalina G McCoy, MD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 5, 2021
• Study Start: June 4, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)