A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-04

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Hypoglycemia Diabetes Type 1 Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Community Paramedic Program

Intervention Type 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.

Education Material

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Education Material

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No