PreDiabetesNCT05265312
Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care
A study testing START diabetes prevention clinical pathway in people with PreDiabetes and Prediabetic State, run by Johns Hopkins University at 1 site in United States.
Trial summary
Prediabetes is a significant public health problem affecting 88 million U.S. adults. Evidence suggest that the vast majority of people with prediabetes are unaware of having this condition and many are not receiving appropriate care for prediabetes, including referral to evidence-based programs like the Diabetes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes, Prediabetic State
- What is being tested?
- START diabetes prevention clinical pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,910 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2022to 2 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Prediabetes based on prediabetes registry
- Age ≥ 18 years
- PCP visit during intervention period
- Patient of Johns Hopkins Green Spring Station (GSS) General Internal Medicine or Johns Hopkins Community Physicians (JHCP) Internal Medicine clinic.
Who cannot join
- Visit with clinician who's not their Primary Care Physician (PCP)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins General Internal Medicine clinic at Green Spring Station
Lutherville, Maryland, 21204
About this study
Prediabetes is a significant public health problem affecting 88 million U.S. adults. Evidence suggest that the vast majority of people with prediabetes are unaware of having this condition and many are not receiving appropriate care for prediabetes, including referral to evidence-based programs like the Diabetes Prevention Programs (DPP). In the investigator's retrospective cohort study of patients with prediabetes from Johns Hopkins Health Systems, the investigators found that the rates of prediabetes clinical care activities are low. In the investigators' qualitative studies, the investigators found that primary care physician (PCP) barriers include low knowledge about Diabetes Prevention Programs and misperceptions of insurance coverage of these programs and inadequate clinical staff to address prediabetes. Common patient barriers to taking action to prevent diabetes include lack of motivation, time and resources.
Based on prior research, comprehensive strategies are urgently needed to improve prediabetes care. Using these findings, the investigators have designed and plan to implement a diabetes prevention clinical pathway which seeks to address some of these common clinician and patient barriers. The investigators hypothesize that the clinical pathway will result in increased clinician screening and intervention and improve patient engagement in diabetes prevention. The investigators will compare results from the intervention clinic compared to a control clinic. If successful, the investigators plan to implement and test the effectiveness of this clinical pathway across the entire health system.
- Conditions
- PreDiabetes, Prediabetic State
- Being tested
- START diabetes prevention clinical pathway
- Keywords
- Diabetes prevention, Primary care, Clinical pathway, Pragmatic intervention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
START diabetes prevention clinical pathwayOther
The diabetes prevention clinical pathway will focus on the following steps:
- Screen/test - testing of eligible patients for prediabetes/diabetes
- Education - PCPs will be encouraged to take an online learning module and in-person group training on prediabetes management and patients with prediabetes will receive a handout about prediabetes prior to their upcoming PCP visit
- Action - PCPs will use a shared decision-making guide and treatment algorithm to discuss options with patients at their visit
- Referral - patients may be referred to DPPs and/or medical nutrition therapy (MNT)
- Treat - patients will be scheduled for a follow-up visit within 3-9 months with their PCP or care team to continue addressing prediabetes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention clinic | Active comparator | Patients with prediabetes seen for routine care at intervention clinic Receives: Other: START diabetes prevention clinical pathway |
| Control clinic | No intervention | Patients with prediabetes seen for routine care at control clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit
Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period
Measured: 12 months
Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days
Measured: 12 months
Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days
Measured: 12 months
Secondary outcomes (2)
Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period
Fasting glucose or Hemoglobin A1c
Measured: 12 months
Achieve 5% or Greater Reduction in Weight Compared to Baseline
Proportion achieving 5% or greater weight reduction
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start31 May 2022
- Primary completion2 Jun 2023
- Study completion2 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,910 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Tseng, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265312
- Sponsor's protocol ID
- IRB00313490
- Other IDs
- K23DK118205
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2022
- Last updated
- 5 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care
- ClinicalTrials.gov ID
- NCT05265312
- Acronym / sponsor ID
- IRB00313490
- Conditions
- PreDiabetes, Prediabetic State
- Keywords
- Diabetes prevention, Primary care, Clinical pathway, Pragmatic intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,910 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 31 May 2022 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jul 2023 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Posted 25 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prediabetes is a significant public health problem affecting 88 million U.S. adults. Evidence suggest that the vast majority of people with prediabetes are unaware of having this condition and many are not receiving appropriate care for prediabetes, including referral to evidence-based programs like the Diabetes Prevention Programs (DPP). In the investigator's retrospective cohort study of patients with prediabetes from Johns Hopkins Health Systems, the investigators found that the rates of prediabetes clinical care activities are low. In the investigators' qualitative studies, the investigators found that primary care physician (PCP) barriers include low knowledge about Diabetes Prevention Programs and misperceptions of insurance coverage of these programs and inadequate clinical staff to address prediabetes. Common patient barriers to taking action to prevent diabetes include lack of motivation, time and resources.
Based on prior research, comprehensive strategies are urgently needed to improve prediabetes care. Using these findings, the investigators have designed and plan to implement a diabetes prevention clinical pathway which seeks to address some of these common clinician and patient barriers. The investigators hypothesize that the clinical pathway will result in increased clinician screening and intervention and improve patient engagement in diabetes prevention. The investigators will compare results from the intervention clinic compared to a control clinic. If successful, the investigators plan to implement and test the effectiveness of this clinical pathway across the entire health system.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention clinic | Active comparator | Other: START diabetes prevention clinical pathwayPatients with prediabetes seen for routine care at intervention clinic |
| Control clinic | No intervention | –Patients with prediabetes seen for routine care at control clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prediabetes based on prediabetes registry
- Age ≥ 18 years
- PCP visit during intervention period
- Patient of Johns Hopkins Green Spring Station (GSS) General Internal Medicine or Johns Hopkins Community Physicians (JHCP) Internal Medicine clinic.
Key exclusion criteria (1 listed)
- Visit with clinician who's not their Primary Care Physician (PCP)
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 |
|---|---|---|
| START diabetes prevention clinical pathwayThe diabetes prevention clinical pathway will focus on the following steps: 1. Screen/test - testing of eligible patients for prediabetes/diabetes 2. Education - PCPs will be encouraged to take an online learning module and in-person group training on prediabetes management and patients with prediabetes will receive a handout about prediabetes prior to their upcoming PCP visit 3. Action - PCPs will use a shared decision-making guide and treatment algorithm to discuss options with patients at their visit 4. Referral - patients may be referred to DPPs and/or medical nutrition therapy (MNT) 5. Treat - patients will be scheduled for a follow-up visit within 3-9 months with their PCP or care team to continue addressing prediabetes. | Other | Intervention clinic |
Primary outcome
Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit
Time frame: 12 months
Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period
Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days
Time frame: 12 months
Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days
Time frame: 12 months
2 secondary outcomes
Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period
Time frame: 12 months
Achieve 5% or Greater Reduction in Weight Compared to Baseline
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Eva Tseng, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing START diabetes prevention clinical pathway in people with PreDiabetes and Prediabetic State, run by Johns Hopkins University 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 4 inclusion and 1 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 5 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 25 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2025.