Clinical trial NCT04874532: A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia
Official title: Community Paramedicine Program to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Diabetes
Hypoglycemia
Diabetes Type 1
Diabetes Type 2
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-05-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diabetes Self-Management
timeFrame: Baseline, 1 month, 4 months
Secondary outcomes:
measure: Self-reported hypoglycemia
timeFrame: Baseline, 1 month, 4 months
measure: Health-related Quality of life (EQ-5D)
timeFrame: Baseline, 1 month, 4 months
measure: Diabetes distress
timeFrame: Baseline, 1 month, 4 months
measure: Glycemic control
timeFrame: Baseline, 4 months
measure: Qualitative experience with hypoglycemia and its prevention
timeFrame: Baseline (one-time interview only)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rozalina G McCoy, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: