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Evaluation of the Impact of Continuous Glucose Monitoring (CGM) Systems on Glycemic Control in People With Prediabetes: Postmarketing Clinical Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This prospective, randomized controlled trial evaluates whether real-time continuous glucose monitoring (CGM) improves glycemic control and lifestyle adherence in adults with prediabetes compared to conventional self-monitoring methods over a 3-month period. By analyzing metabolic markers and behavioral data, the study aims to determine the effectiveness of 24-hour monitoring as a personalized tool that increases patient adherence to lifestyle changes compared to conventional SMBG methods.

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

• Age of 18 years and older.

• Presence of prediabetes diagnosed according to criteria of the American Diabetes Association

• Persons who treated with diet and exercise alone or metformin on a stabilized dose for at least 3 months before the study;

• Ability to comply with protocol requirements and maintain a patient diary.

• Signed informed consent.

Locations
Other Locations
Ukraine
Bogomolets National Medical University
RECRUITING
Kyiv
University Hospital of Bogomolets National Medical University
RECRUITING
Kyiv
Contact Information
Primary
Nazarii Kobyliak, Professor
nazariikobyliak@gmail.com
+380442356005
Backup
Ilona Rudneva, Dr
ilonarudneva57@gmail.com
0442356005
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 80
Treatments
Experimental: CGM group
Participants with prediabetes will be provided with a Real-Time Continuous Glucose Monitoring (RT-CGM) device to monitor their blood glucose along with educational materials to better understand and manage their prediabetes and other supporting services. Pre and post intervention surveys and investigation will be implemented. Participants will be utilizing RT-CGM device for 28 days and then followed up for 3-month participation.
Active_comparator: traditional fingerstick glucometer
Participants with prediabetes will be provided with traditional fingerstick glucometer device to self-monitor their blood glucose along with educational materials to better understand and manage their prediabetes and other supporting services. Pre and post intervention surveys and investigation will be implemented. Participants will be utilizing glucometer with at least 2-3 measurements per week for 28 days and then followed up for 3-month participation.
Related Therapeutic Areas
Sponsors
Collaborators: Iridium LLC, COR-Medical LLC
Leads: Nazarii Kobyliak

This content was sourced from clinicaltrials.gov