PrediabetesRISENCT07553325
Risk-informed Shared-decision Making Engagement Strategy for Patients With Prediabetes
A study testing Risk Informed Shared Decision-Making Strategy (RISE) and Low Touch Messaging Strategy (LTM) in people with Prediabetes and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if knowing risk for diabetes can help adult patients with prediabetes take steps to get care and prevent diabetes. The main questions it aims to answer are: Does a shared-decision making visit with a health care team member to talk about the participant's diabetes risk… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
- What is being tested?
- Risk Informed Shared Decision-Making Strategy (RISE) and Low Touch Messaging Strategy (LTM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2026to 1 Apr 2028
- Phase
- Interventional
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prediabetes based on most recent HbA1c (5.7-6.4%) or fasting plasma glucose (100-125 mg/dL) in prior 12 months
- active patient portal account (MyChart)
- patient receiving primary care at Johns Hopkins Community Physicians in Frederick
- have overweight or obesity (BMI ≥ 25 kg/m2)
Who cannot join
- have diabetes (HbA1c > 6.4% in prior 6 months or on diabetes registry)
- have dementia
- previously participated in the Diabetes Prevention Program (DPP)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eva Tseng, MD, MPH contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Community Physicians Frederick
Frederick, Maryland, 21702
Study Principal Investigator, 410-614-4396, preventdiabetes@jhu.edu
Eva Tseng, MD, MPH
About this study
Official title: Pilot Trial of a Risk-informed Shared-decision Engagement Strategy
The goal of this clinical trial is to learn if knowing risk for diabetes can help adult patients with prediabetes take steps to get care and prevent diabetes. The main questions it aims to answer are:
- Does a shared-decision making visit with a health care team member to talk about the participant's diabetes risk increase participants' taking steps to prevent diabetes?
- Does a simple message in the patient portal about the participant's diabetes risk increase participants' taking steps to prevent diabetes?
Read more
Researchers will compare the visit with usual care at the clinic to see if the visit increases participants' taking steps to prevent diabetes. Separately, the researchers will compare the patient message with usual care at the clinic to see if the message increases participants' taking steps to prevent diabetes.
Participants will:
- Complete surveys at the beginning of the study and up to 2 additional surveys
- If the participant falls into the shared decision-making group, the participant will have one 30-minute visit with a healthcare team member to talk about risk of diabetes and how to lower it.
- Being tested
- Risk Informed Shared Decision-Making Strategy (RISE), Low Touch Messaging Strategy (LTM)
- Keywords
- shared decision-making, diabetes risk, diabetes prevention
- Medical subject headings
- Prediabetic State, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Informed Shared Decision-Making Strategy (RISE)Other
Single visit with health care team member to discuss diabetes risk and choosing next steps
Low Touch Messaging Strategy (LTM)Other
Single message delivered via patient portal system describing diabetes risk and tips to lower risk
| Study group | Role | What they receive |
|---|---|---|
| Risk-Informed Shared Decision-Making Engagement Strategy | Active comparator | Participants will have one visit with a healthcare team member to talk about the participant's risk of diabetes and how to lower it. Receives: Other: Risk Informed Shared Decision-Making Strategy (RISE) |
| Low Touch Messaging Strategy | Active comparator | Participants receive a simple message in the patient portal describing the participant's level of risk of diabetes and tips on how to lower the risk Receives: Other: Low Touch Messaging Strategy (LTM) |
| Usual Care | No intervention | Participants will continue with usual care at the clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a DPP referral or new metformin prescription
Prediabetes treatment uptake - Presence of a DPP referral or new metformin prescription based on electronic health record data
Measured: From randomization to 3 months after randomization
Secondary outcomes (6)
Proportion of patients enrolled in the DPP
DPP enrollment- Proportion of patients enrolled in the DPP -
Measured: Referral to 6 months after DPP referral
Proportion of patients who complete ≥ 9 months of the DPP
DPP completion- Proportion of patients who complete ≥ 9 months of the DPP
Measured: From enrollment to 12 months of follow-up
Weight change (kg)
Change in body weight
Measured: From enrollment to 12 months
Metformin adherence
Proportion of participants with a new metformin prescription who have a proportion-of-days covered (PDC) value of ≥0.80 (calculated as the sum of days' supply of metformin divided by the number of days between the first fill and end of follow-up period).
Measured: From enrollment to 12 months
Hemoglobin A1c change
Absolute change in hemoglobin A1c
Measured: From enrollment to 12 months
Patient Activation Measure
Patient Activation Measure (PAM) scored as Level 1(disengaged) - 4 (proactive)
Measured: From enrollment to 3 months and from enrollment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start7 Aug 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Eva Tseng, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553325
- Sponsor's protocol ID
- IRB00538220
- Acronym
- RISE
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified IPD used in the results publication will be shared