An interventional study of Risk Informed Shared Decision-Making Strategy (RISE) and Low Touch Messaging Strategy (LTM) in Prediabetes and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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:
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:
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 120 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will have one visit with a healthcare team member to talk about the participant's risk of diabetes and how to lower it.
Other: Risk Informed Shared Decision-Making Strategy (RISE)
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
Other: Low Touch Messaging Strategy (LTM)
Participants will continue with usual care at the clinic
Single visit with health care team member to discuss diabetes risk and choosing next steps
Single message delivered via patient portal system describing diabetes risk and tips to lower risk
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
Time frame: From randomization to 3 months after randomization
Proportion of patients enrolled in the DPP
DPP enrollment- Proportion of patients enrolled in the DPP -
Time frame: 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
Time frame: From enrollment to 12 months of follow-up
Weight change (kg)
Change in body weight
Time frame: 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).
Time frame: From enrollment to 12 months
Hemoglobin A1c change
Absolute change in hemoglobin A1c
Time frame: From enrollment to 12 months
Patient Activation Measure
Patient Activation Measure (PAM) scored as Level 1(disengaged) - 4 (proactive)
Time frame: From enrollment to 3 months and from enrollment to 12 months
Plan to share: Yes — Only de-identified IPD used in the results publication will be shared
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 1 year after publication with no end date
Access criteria: All de-identified datasets that can be shared will be deposited in figshare, an open access ADA-approved repository.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 12 months is below that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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