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The Impact of Continuous Glucose Monitoring on Behavioral Change, Glucose Variability and Weight Loss in Individuals With Prediabetes and Obesity - a Randomized Crossover Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Adults aged 18-70 years.

• BMI ≥ 27 kg/m² (overweight or obese).

• Prediabetes, confirmed by:

⁃ Impaired fasting glucose (IFG: 5.6-6.9 mmol/L), and/or Impaired glucose tolerance (IGT: 2-hour OGTT glucose 7.8-11.0 mmol/L).

• Stable body weight (±3 kg) in the last 3 months.

• No current use of antidiabetic or weight-loss medications.

• Willingness and ability to wear a CGM device as instructed.

• Capacity to provide written informed consent.

• Recruitment from the Diabetes Outpatient Clinic, Community Health Center Koper (identified and invited from the clinic's database).

Locations
Other Locations
Slovenia
University of Primorska, Faculty of Health Sciences
RECRUITING
Izola
Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia
RECRUITING
Koper
Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
Ajda Urbas, medical doctor
ajda.urbas@gmail.com
0038631626966
Time Frame
Start Date: 2026-09-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 34
Treatments
Experimental: Open CGM
Experimental: Blinded CGM
Related Therapeutic Areas
Sponsors
Collaborators: University Medical Centre Ljubljana, Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia
Leads: University of Primorska

This content was sourced from clinicaltrials.gov