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Community Paramedic Intervention for Diabetes Management

N/A
Waitlist Available
Led By Rozalina G McCoy, MD, MS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Experience of level 3 hypoglycemia
Type 1 or type 2 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 4 months
Awards & highlights

Study Summary

This trial will study a new intervention delivered by community paramedics to improve diabetes self-management and reduce diabetes distress.

Who is the study for?
Adults over 18 living in specific counties of southeast Minnesota with Type 1 or Type 2 diabetes who have had a severe low blood sugar event and can give informed consent. They must not be in long-term care, terminally ill, lack English skills, enrolled in certain programs, under hospice care, or have cognitive issues preventing consent.Check my eligibility
What is being tested?
The trial is testing Diabetes-REM intervention by community paramedics to improve self-care for diabetes patients who've had serious hypoglycemia. It aims to prevent further episodes, reduce stress related to diabetes management and enhance life quality.See study design
What are the potential side effects?
Since the interventions involve education and support rather than medications, there are no direct side effects like those from drugs. However, participants may experience varying levels of stress or anxiety as they adjust their lifestyle and habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had severe low blood sugar that needed help from another person.
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I have diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diabetes Self-Management
Secondary outcome measures
Diabetes distress
Glycemic control
Health-related Quality of life (EQ-5D)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Community Paramedic (CP) program and Education MaterialsExperimental Treatment2 Interventions
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.
Group II: Usual Care and Education MaterialsActive Control1 Intervention
Subjects will receive printed diabetes education materials and a resource guide for contacting their diabetes care team in addition to usual care.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,242 Previous Clinical Trials
3,773,334 Total Patients Enrolled
22 Trials studying Diabetes
6,713 Patients Enrolled for Diabetes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,377 Previous Clinical Trials
4,315,661 Total Patients Enrolled
106 Trials studying Diabetes
138,638 Patients Enrolled for Diabetes
Rozalina G McCoy, MD, MSPrincipal InvestigatorMayo Clinic

Media Library

Community Paramedic Program Clinical Trial Eligibility Overview. Trial Name: NCT04874532 — N/A
Diabetes Research Study Groups: Community Paramedic (CP) program and Education Materials, Usual Care and Education Materials
Diabetes Clinical Trial 2023: Community Paramedic Program Highlights & Side Effects. Trial Name: NCT04874532 — N/A
Community Paramedic Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04874532 — N/A
~21 spots leftby Dec 2024
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