A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia

Diabetes Clinical Trial

Official title:

Community Paramedicine Program to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04874532
• Other study ID #: 20-006799
• Secondary ID: R03DK127010
• Status: Suspended
• Phase: N/A
• Start date: June 4, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetes Type 1
• Diabetes Type 2
• Hypoglycemia

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes Self-Management	Change in Diabetes Self-Management Questionnaire (DSMQ) score	Baseline, 1 month, 4 months
Secondary	Self-reported hypoglycemia	Self-reported level 1 and level 2 hypoglycemia	Baseline, 1 month, 4 months
Secondary	Health-related Quality of life (EQ-5D)	Change in EQ-5D score	Baseline, 1 month, 4 months
Secondary	Diabetes distress	Change in the Diabetes Distress Scale	Baseline, 1 month, 4 months
Secondary	Glycemic control	Hemoglobin A1c level	Baseline, 4 months
Secondary	Qualitative experience with hypoglycemia and its prevention	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.	Baseline (one-time interview only)