Status:
SUSPENDED
A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes
Hypoglycemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 comp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04874532
Start Date
June 4 2021
End Date
December 31 2025
Last Update
April 4 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905