Risk-informed Shared-decision Making Engagement Strategy for Patients With Prediabetes

NCT07553325 | Not Yet Recruiting

• 1 other identifier: IRB00538220
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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? 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.

Conditions

Prediabetes; Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Keywords

shared decision-making; diabetes risk; diabetes prevention

Outcome Measures

Primary Outcomes (1)

• 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

  From randomization to 3 months after randomization

Secondary Outcomes (6)

• Proportion of patients enrolled in the DPP

  Referral to 6 months after DPP referral

• Proportion of patients who complete ≥ 9 months of the DPP

  From enrollment to 12 months of follow-up

• Weight change (kg)

  From enrollment to 12 months

• Metformin adherence

  From enrollment to 12 months

• Hemoglobin A1c change

  From enrollment to 12 months

Study Arms (3)

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.

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

Other: Low Touch Messaging Strategy (LTM)

Usual Care

NO INTERVENTION

Participants will continue with usual care at the clinic

Interventions

Risk Informed Shared Decision-Making Strategy (RISE) OTHER

Single visit with health care team member to discuss diabetes risk and choosing next steps

Risk-Informed Shared Decision-Making Engagement Strategy

Low Touch Messaging Strategy (LTM) OTHER

Single message delivered via patient portal system describing diabetes risk and tips to lower risk

Low Touch Messaging Strategy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• have diabetes (HbA1c \> 6.4% in prior 6 months or on diabetes registry)
• have dementia
• previously participated in the Diabetes Prevention Program (DPP)

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Diabetes Association: collaborator

Study Sites (1)

Johns Hopkins Community Physicians Frederick

Frederick, Maryland, 21702, United States

Location

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Hyperglycemia

Study Officials

• Eva Tseng, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Study Coordinator

CONTACT

410-614-4396; preventdiabetes@jh.edu

Eva Tseng, MD, MPH

CONTACT

etseng3@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)