A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04874532
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
150
1
2
32.8
4.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Community Paramedic Program
  • Other: Education Material
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Community Paramedicine Program to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia
Actual Study Start Date :
Jun 4, 2021
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Community Paramedic (CP) program and Education Materials

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.

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.

Other: 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.

Active Comparator: Usual Care and Education Materials

Subjects will receive printed diabetes education materials and a resource guide for contacting their diabetes care team in addition to usual care.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Diabetes Self-Management [Baseline, 1 month, 4 months]

    Change in Diabetes Self-Management Questionnaire (DSMQ) score

Secondary Outcome Measures

  1. Self-reported hypoglycemia [Baseline, 1 month, 4 months]

    Self-reported level 1 and level 2 hypoglycemia

  2. Health-related Quality of life (EQ-5D) [Baseline, 1 month, 4 months]

    Change in EQ-5D score

  3. Diabetes distress [Baseline, 1 month, 4 months]

    Change in the Diabetes Distress Scale

  4. Glycemic control [Baseline, 4 months]

    Hemoglobin A1c level

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Rozalina G McCoy, MD, MS, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Rozalina G. McCoy, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04874532
Other Study ID Numbers:
  • 20-006799
  • K23DK114497
First Posted:
May 5, 2021
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2022