A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia
Primary Purpose
Diabetes, Hypoglycemia, Diabetes Type 1
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Paramedic Program
Education Material
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes
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:
- Treated by Mayo Clinic Ambulance for hypoglycemia
- Treated in Mayo Clinic ED or hospital for hypoglycemia.
- Patients who self-report experiencing level 3 hypoglycemia. These patients will be identified through: (1) recruitment letters mailed via patient portal or postal mail to patients at risk for hypoglycemia based on validated hypoglycemia risk score (for type 2 diabetes), insulin therapy, or diagnosis of type 1 diabetes, telling them about the study and offering enrollment if they had experienced level 3 (severe) hypoglycemia; (2) dissemination of information about the study to primary care clinicians, endocrinologists, certified diabetes care and education specialists (CDCES), medication therapy management pharmacists, dieticians, and primary care team nurses (who support primary care clinicians with diabetes management) to tell patients about the trial if patients self-report severe hypoglycemia; (3) patients with hypoglycemia-related ambulatory visits or documentation of hypoglycemia on their problem list.
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Community Paramedic (CP) program and Education Materials
Usual Care and Education Materials
Arm Description
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.
Subjects will receive printed diabetes education materials and a resource guide for contacting their diabetes care team in addition to usual care.
Outcomes
Primary Outcome Measures
Diabetes Self-Management
Change in Diabetes Self-Management Questionnaire (DSMQ) score
Secondary Outcome Measures
Self-reported hypoglycemia
Self-reported level 1 and level 2 hypoglycemia
Health-related Quality of life (EQ-5D)
Change in EQ-5D score
Diabetes distress
Change in the Diabetes Distress Scale
Glycemic control
Hemoglobin A1c level
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.
Full Information
NCT ID
NCT04874532
First Posted
May 3, 2021
Last Updated
July 20, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04874532
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 4, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypoglycemia, Diabetes Type 1, Diabetes Type 2
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Community Paramedic (CP) program and Education Materials
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care and Education Materials
Arm Type
Active Comparator
Arm Description
Subjects will receive printed diabetes education materials and a resource guide for contacting their diabetes care team in addition to usual care.
Intervention Type
Other
Intervention Name(s)
Community Paramedic Program
Intervention Description
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
Intervention Name(s)
Education Material
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diabetes Self-Management
Description
Change in Diabetes Self-Management Questionnaire (DSMQ) score
Time Frame
Baseline, 1 month, 4 months
Secondary Outcome Measure Information:
Title
Self-reported hypoglycemia
Description
Self-reported level 1 and level 2 hypoglycemia
Time Frame
Baseline, 1 month, 4 months
Title
Health-related Quality of life (EQ-5D)
Description
Change in EQ-5D score
Time Frame
Baseline, 1 month, 4 months
Title
Diabetes distress
Description
Change in the Diabetes Distress Scale
Time Frame
Baseline, 1 month, 4 months
Title
Glycemic control
Description
Hemoglobin A1c level
Time Frame
Baseline, 4 months
Title
Qualitative experience with hypoglycemia and its prevention
Description
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.
Time Frame
Baseline (one-time interview only)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rozalina G McCoy, MD, MS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia
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