The Impact of Continuous Glucose Monitoring on Glucose Variability and Weight Loss in Individuals With Prediabetes and Obesity
NCT07423065 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2026-04-28
Summary
This randomized, crossover interventional study evaluates the effects of real-time (open) versus blinded continuous glucose monitoring (CGM) on glycemic variability, lifestyle behaviors, and metabolic outcomes in adults with prediabetes and overweight or obesity (BMI ≥ 27 kg/m²). Thirty participants will undergo both open and blinded CGM phases, separated by a washout period. The study aims to assess whether access to real-time glucose data promotes behavioral change and improves metabolic health compared with blinded CGM use.
Conditions
- Pre Diabetic
- Obesity & Overweight
Interventions
- DEVICE
-
Continuous Glucose Monitoring (CGM)
Use of a continuous glucose monitoring system to measure interstitial glucose levels. During the open CGM phase, participants have real-time access to glucose data; during the blinded CGM phase, glucose data are masked from participants.
Sponsors & Collaborators
-
Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia
collaborator UNKNOWN -
University Medical Centre Ljubljana
collaborator OTHER -
University of Primorska
lead OTHER
Principal Investigators
-
Ajda Urbas, MD · Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia
-
Mojca Jensterle Sever, PhD · University Medical Centre Ljubljana, Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana
-
Zala Jenko Pražnikar, PhD · University of Primorska, Faculty of Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2027-04-01
- Completion
- 2027-09-01
Countries
- Slovenia
Study Locations
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