DiabetesNCT04874532
A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia
A study testing Community Paramedic Program and Education Material in people with Diabetes and Hypoglycemia, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hypoglycemia, Diabetes Type 1
- What is being tested?
- Community Paramedic Program and Education Material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Community Paramedicine Program to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia
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.
Read the 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.
- Conditions
- Diabetes, Hypoglycemia, Diabetes Type 1, Diabetes Type 2
- Being tested
- Community Paramedic Program, Education Material
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Paramedic ProgramOther
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.
Education MaterialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Community Paramedic Program; Other: Education Material |
| 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. Receives: Other: Education Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Self-Management
Change in Diabetes Self-Management Questionnaire (DSMQ) score
Measured: Baseline, 1 month, 4 months
Secondary outcomes (5)
Self-reported hypoglycemia
Self-reported level 1 and level 2 hypoglycemia
Measured: Baseline, 1 month, 4 months
Health-related Quality of life (EQ-5D)
Change in EQ-5D score
Measured: Baseline, 1 month, 4 months
Diabetes distress
Change in the Diabetes Distress Scale
Measured: Baseline, 1 month, 4 months
Glycemic control
Hemoglobin A1c level
Measured: 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.
Measured: Baseline (one-time interview only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start4 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Unable to deliver the intervention due to program staffing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rozalina G. McCoy, Mayo Clinic
- Investigators
- Rozalina G McCoy, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874532
- Sponsor's protocol ID
- 20-006799
- Other IDs
- R03DK127010
- Status last verified
- Apr 2026
- First submitted
- 3 May 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40489473
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Paramedicine Program to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia
- ClinicalTrials.gov ID
- NCT04874532
- Acronym / sponsor ID
- 20-006799
- Conditions
- Diabetes, Hypoglycemia, Diabetes Type 1, Diabetes Type 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Unable to deliver the intervention due to program staffing.
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Paramedic (CP) program and Education Materials | Experimental | Other: Community Paramedic Program, Other: Education MaterialSubjects 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. |
| Usual Care and Education Materials | Active comparator | Other: Education MaterialSubjects will receive printed diabetes education materials and a resource guide for contacting their diabetes care team in addition to usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Paramedic ProgramPatients 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 | Community Paramedic (CP) program and Education Materials |
| Education MaterialParticipants 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. | Other | Community Paramedic (CP) program and Education Materials, Usual Care and Education Materials |
Primary outcome
Diabetes Self-Management
Time frame: Baseline, 1 month, 4 months
Change in Diabetes Self-Management Questionnaire (DSMQ) score
5 secondary outcomes
Self-reported hypoglycemia
Time frame: Baseline, 1 month, 4 months
Health-related Quality of life (EQ-5D)
Time frame: Baseline, 1 month, 4 months
Diabetes distress
Time frame: Baseline, 1 month, 4 months
Glycemic control
Time frame: Baseline, 4 months
Qualitative experience with hypoglycemia and its prevention
Time frame: Baseline (one-time interview only)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Derived from this study: PubMed 40489473Bhagra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rozalina G McCoy, MD, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Paramedic Program and Education Material in people with Diabetes and Hypoglycemia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-Management (time frame: Baseline, 1 month, 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04874532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.