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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK127010 | U.S. NIH Grant/Contract | View source |
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Unable to deliver the intervention due to program staffing.
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community Paramedic (CP) program and Education Materials | Experimental | 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. |
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| Usual Care and Education Materials | Active Comparator | Subjects will receive printed diabetes education materials and a resource guide for contacting their diabetes care team in addition to usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Paramedic Program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Self-Management | Change in Diabetes Self-Management Questionnaire (DSMQ) score | Baseline, 1 month, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported hypoglycemia | Self-reported level 1 and level 2 hypoglycemia | Baseline, 1 month, 4 months |
| Health-related Quality of life (EQ-5D) | Change in EQ-5D score |
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Inclusion Criteria:
Identifying patients who experienced level 3 hypoglycemia:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rozalina G McCoy, MD, MS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40489473 | Derived | Bhagra S, Ducharme-Smith AL, Juntunen MB, Liedl CP, Golembiewski EH, Sundt WJ, Krpata TS, Lampman MA, Espinoza AL, McCoy RR. Diabetes rescue, engagement, and management (D-REM) for hypoglycemia: Clinical trial protocol of a community paramedic program to improve diabetes management among adults with severe hypoglycemia. PLoS One. 2025 Jun 9;20(6):e0322177. doi: 10.1371/journal.pone.0322177. eCollection 2025. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2021 | Apr 16, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007003 | Hypoglycemia |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Education Material | Other | 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. |
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| Baseline, 1 month, 4 months |
| Diabetes distress | Change in the Diabetes Distress Scale | Baseline, 1 month, 4 months |
| Glycemic control | Hemoglobin A1c level | Baseline, 4 months |
| 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) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |