A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia

Not Applicable

Suspended

• Conditions: Hypoglycemia; Diabetes; Diabetes Type 1; Diabetes Type 2
• Interventions: Other: Community Paramedic Program; Other: Education Material

• Registration Number: NCT04874532
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-05
• Study Start: 2021-06-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Paramedic (CP) program and Education Materials	Community Paramedic Program	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.
Community Paramedic (CP) program and Education Materials	Education Material	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.
Usual Care and Education Materials	Education Material	Subjects will receive printed diabetes education materials and a resource guide for contacting their diabetes care team in addition to usual care.

Primary Outcome Measures

Name	Time	Method
Diabetes Self-Management	Baseline, 1 month, 4 months	Change in Diabetes Self-Management Questionnaire (DSMQ) score

Secondary Outcome Measures

Name	Time	Method
Diabetes distress	Baseline, 1 month, 4 months	Change in the Diabetes Distress Scale
Glycemic control	Baseline, 4 months	Hemoglobin A1c level
Self-reported hypoglycemia	Baseline, 1 month, 4 months	Self-reported level 1 and level 2 hypoglycemia
Health-related Quality of life (EQ-5D)	Baseline, 1 month, 4 months	Change in EQ-5D score
Qualitative experience with hypoglycemia and its prevention	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States