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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

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I have had severe low blood sugar that needed help from another person.

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I have diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 4 months

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,634 Total Patients Enrolled

21 Trials studying Diabetes

6,653 Patients Enrolled for Diabetes

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,356 Previous Clinical Trials

4,314,916 Total Patients Enrolled

106 Trials studying Diabetes

138,513 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this clinical trial?

"The records on clinicaltrials.gov make clear that this experiment has terminated its recruitment process, having been first posted on June 4th 2021 and last updated November 28th 2022. Fortunately, there are a plethora of other trials currently recruiting new patients to participate in the interim."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia

Rozalina G. McCoy 2021. "A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04874532.

All > Hypoglycemia