Diabetes, Diabetes Type 1, Diabetes Type 2, Hypoglycemia
Conditions
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.
Interventions
OTHEREducation 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.
OTHERCommunity 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.
Sponsors
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Self-Management | Baseline, 1 month, 4 months | Change in Diabetes Self-Management Questionnaire (DSMQ) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Diabetes distress | Baseline, 1 month, 4 months | Change in the Diabetes Distress Scale |
| Glycemic control | Baseline, 4 months | Hemoglobin A1c level |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRozalina G McCoy, MD, MS
Mayo Clinic
Outcome results
None listed