CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
ConditionPreDiabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorState University of New York at Buffalo
About this trial
Prediabetes affects over one-third of adults in the United States, placing them at a higher risk for developing type 2 diabetes and heart disease, which can lead to serious health complications and increased medical costs. Although a program called the Diabetes Prevention Program (DPP) has been shown to lower the risk of diabetes through healthy lifestyle changes, many people find it difficult to stick with these changes over the long term. This study seeks to find out if combining DPP coaching with continuous glucose monitoring (CGM) technology can help people stay on track with their health goals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults aged 18 years or older,
diagnosis of prediabetes, as defined by current clinical guidelines (HbA1c 5.7% to 6.4%, fasting plasma glucose 100-125 mg/dL, or 2-hour plasma glucose 140-199 mg/dL following a 75g oral glucose tolerance test),
body mass index (BMI) of at least 24 kg/m² (or 22 kg/m² for Asian Americans),
willingness to comply with all aspects of the study protocol, including attending coaching sessions and using CGM devices.
Disqualifiers
have a diagnosis of type 1 or type 2 diabetes,
are currently using CGMs or have medical contraindications to CGM use, such as severe skin allergies or implantable defibrillators, or
are currently enrolled in another clinical trial for prediabetes. Additionally, using validated assessments, we will exclude participants with significant dementia, alcohol or drug abuse/dependency, active psychosis, or life expectancy less than 12 months as these conditions are likely to interfere with adherence to the intervention.
Trial design
Design model
Parallel
Treatments tested in this trial
CGM-DPP
BehavioralParticipants in the DPP who receive personalized CGM coaching.
Control
BehavioralParticipants in control group will be referred to DPP.
Treatment groups
214 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Glycemic Control (HbA1c)
Blood specimens (10 cc of blood) will be obtain by trained phlebotomists or nurse for HbA1c.
Time frame
Change from baseline HbA1c at 12 months post intervention follow-upsSecondary outcomes
1
Quality of Life as measured by SF-12
The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.
Time frame
Change from baseline quality of life measure at 12 months post intervention follow-upsOther outcomes
1
Self-Care
Behavioral skills will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale (Toobert 2000), a brief, validated questionnaire of diabetes self-care.
Time frame
Change from baseline self-care at 12 months post intervention follow-upsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov