DiabetesNCT04385758
Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes
A study testing Diabetes-REM Program in people with Diabetes and Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is evaluate the effectiveness of Diabetes-REM (Rescue, Engagement, and Management), a comprehensive community paramedic (CP) program to support adults in Southeast Minnesota (Mower, Freeborn, and Olmsted counties) and Northwest Wisconsin (Barron, Rusk, and Dunn) who have uncontrolled diabetes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus
- What is being tested?
- Diabetes-REM Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to 10 Feb 2022
- 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
- Most recent hemoglobin A1c ≥ 9% within the last 2 years.
- Age ≥ 18 years old.
- Type 1 or type 2 diabetes.
- Paneled to a Mayo Clinic or Mayo Clinic Health System practice.
- Able to provide informed consent.
- Proficient in English.
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- Community-dwelling.
- Live in Southeast Minnesota (Mower, Freeborn, or Olmsted counties) or Northwest Wisconsin (Barron, Rusk, or Dunn counties).
- •Community Paramedics who delivered the Diabetes-REM intervention.
Who cannot join
- Cognitive impairment precluding informed consent.
- Lack of conversational English skills.
- Resident of 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.
About this study
The purpose of this study is evaluate the effectiveness of Diabetes-REM (Rescue, Engagement, and Management), a comprehensive community paramedic (CP) program to support adults in Southeast Minnesota (Mower, Freeborn, and Olmsted counties) and Northwest Wisconsin (Barron, Rusk, and Dunn) who have uncontrolled diabetes (HbA1c ≥ 9%) and have experienced an emergency department (ED) visit or hospitalization for any cause in the prior 6 months.
- Conditions
- Diabetes, Diabetes Mellitus
- Being tested
- Diabetes-REM Program
- Keywords
- Community paramedicine, Diabetes mellitus, Diabetes distress
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes-REM ProgramOther
A comprehensive community paramedicine management program designed to support adults with uncontrolled diabetes and a recent emergency department visit or hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Diabetes-REM Program | Experimental | Not described Receives: Other: Diabetes-REM Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress (using DDS)
The level of diabetes-related distress that is expressed by patient participants using the Diabetes Distress Scale (the DDS contains 17 questions, with responses ranging from "Not a Problem" (1) to "A Very Serious Problem" (6). Total scores use the sum of all responses divided by 17, with a mean item score of 3 or higher (moderate distress) indicating distress worthy of clinical attention.)
Measured: 1 month
Secondary outcomes (4)
Diabetes Distress (using DDS)
The level of diabetes-related distress that is expressed by patient participants using the Diabetes Distress Scale (the DDS contains 17 questions, with responses ranging from "Not a Problem" (1) to "A Very Serious Problem" (6). Total scores use the sum of all responses divided by 17, with a mean item score of 3 or higher (moderate distress) indicating distress worthy of clinical attention.)
Measured: 4 months
Confidence in Diabetes Self-Management (using DSMQ)
The level of confidence patient participants express in managing their diabetes using the Diabetes Self-Management Questionnaire (DSMQ)
Measured: 1 and 4 months
Health-Related Quality of Life (using EQ-5D)
Patients participants' self-reported health-related quality of life using the EuroQol 5-D (also known as EQ-5D; an instrument for measuring quality of life)
Measured: 1 and 4 months
Self-Reported Hypoglycemia and Hyperglycemia
Incidences of hypoglycemia (blood glucose <70 mg/dL and <54 mg/dL) and hyperglycemia (blood glucose ≥250 mg/dL) as reported by patient participants
Measured: 1 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start13 Jul 2020
- Primary completion23 Nov 2021
- Study completion10 Feb 2022
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rozalina G. McCoy, Mayo Clinic
- Investigators
- Rozalina McCoy, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385758
- Sponsor's protocol ID
- 20-001011
- Status last verified
- Oct 2022
- First submitted
- 7 May 2020
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Juntunen MB, Liedl CP, Carlson PN, Myers LA, Stickler ZR, Ryan Schultz JA, Meilander AK, Behnken E, Lampman MA, Rogerson MC, Fischer KM, McCoy RG. Diabetes Rescue, Engagement and Management (D-REM): rationale and design of a pragmatic clinical trial of a community paramedicine programme to improve diabetes care. BMJ Open. 2022 Apr 21;12(4):e057224. doi: 10.1136/bmjopen-2021-057224.
PubMed 35450906
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes
- ClinicalTrials.gov ID
- NCT04385758
- Acronym / sponsor ID
- 20-001011
- Conditions
- Diabetes, Diabetes Mellitus
- Keywords
- Community paramedicine, Diabetes mellitus, Diabetes distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 13 May 2020 (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.
The purpose of this study is evaluate the effectiveness of Diabetes-REM (Rescue, Engagement, and Management), a comprehensive community paramedic (CP) program to support adults in Southeast Minnesota (Mower, Freeborn, and Olmsted counties) and Northwest Wisconsin (Barron, Rusk, and Dunn) who have uncontrolled diabetes (HbA1c ≥ 9%) and have experienced an emergency department (ED) visit or hospitalization for any cause in the prior 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes-REM Program | Experimental | Other: Diabetes-REM Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Most recent hemoglobin A1c ≥ 9% within the last 2 years.
- Age ≥ 18 years old.
- 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 (6 listed)
- Cognitive impairment precluding informed consent.
- Lack of conversational English skills.
- Resident of a long-term care facility.
- Enrolled in hospice.
- Enrolled in a care coordination or disease management program.
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 |
|---|---|---|
| Diabetes-REM ProgramA comprehensive community paramedicine management program designed to support adults with uncontrolled diabetes and a recent emergency department visit or hospitalization | Other | Diabetes-REM Program |
Primary outcome
Diabetes Distress (using DDS)
Time frame: 1 month
The level of diabetes-related distress that is expressed by patient participants using the Diabetes Distress Scale (the DDS contains 17 questions, with responses ranging from "Not a Problem" (1) to "A Very Serious Problem" (6). Total scores use the sum of all responses divided by 17, with a mean item score of 3 or higher (moderate distress) indicating distress worthy of clinical attention.)
4 secondary outcomes
Diabetes Distress (using DDS)
Time frame: 4 months
Confidence in Diabetes Self-Management (using DSMQ)
Time frame: 1 and 4 months
Health-Related Quality of Life (using EQ-5D)
Time frame: 1 and 4 months
Self-Reported Hypoglycemia and Hyperglycemia
Time frame: 1 and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Derived from this study: PubMed 35450906Juntunen MB, Liedl CP, Carlson PN, Myers LA, Stickler ZR, Ryan Schultz JA, Meilander AK, Behnken E, Lampman MA, Rogerson MC, Fischer KM, McCoy RG. Diabetes Rescue, Engagement and Management (D-REM): rationale and design of a pragmatic clinical trial of a community paramedicine programme to improve diabetes care. BMJ Open. 2022 Apr 21;12(4):e057224. doi: 10.1136/bmjopen-2021-057224.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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 McCoy, MD 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 Diabetes-REM Program in people with Diabetes and Diabetes Mellitus, 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 7 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Distress (using DDS) (time frame: 1 month). 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 NCT04385758, 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 7 Oct 2022.