Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin

Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin - the Association With Metabolic Control of Diabetes and Markers of Early Vascular Changes

The aim of the study is to assess the influence of continuous glucose monitoring (CGM) systems on metabolic control and quality of life in people with type 2 diabetes and overweight/obesity who are not treated with insulin. Additionally, the study aims to assess the association between metabolic control of diabetes and markers of early cardiovascular disease, taking into account the impact of CGM use.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Continuous glucose monitoring; Device: Self-monitoring of blood glucose

Detailed Description

Pharmacological treatment of type 2 diabetes (T2DM) has advanced significantly in recent years. However, despite increasing availability of new medications, a great proportion of patients do not achieve treatment goals, which leads to an increased risk of chronic complications. Continuous glucose monitoring (CGM) systems have become standard of care in persons with diabetes treated with insulin, although they might also be a useful tool in guiding behaviour and dietary choices in patients treated with non-insulin medications. However, the data on their potential benefits in people with T2DM not using insulin are scarce. Therefore, the study aims to investigate the influence of CGM use on metabolic control and quality of life in this group of patients.

The study subjects will be randomly assigned to one of two groups: using continuous glucose monitoring systems or performing self-monitoring of blood glucose with a glucose meter. The intervention time will be 12 weeks, with control visits every 4 weeks. A post-intervention follow-up visit to assess whether the achieved results are maintained will be performed at 3 months after completing the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Krentowska, MD, PhD; Phone Number: +48858317761; Email: anna.krentowska@umb.edu.pl

Study Locations

• Poland
  • Bialystok, Poland, 15-276
    • Recruiting
    • Medical University of Bialystok, Department of Internal Medicine and Metabolic Diseases
    • Contact: Anna Krentowska, MD, PhD; Phone Number: +48858317761; Email: anna.krentowska@umb.edu.pl
    • Principal Investigator: Anna Krentowska, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 65 years (both inclusive)
• Type 2 diabetes diagnosed at least 6 months prior to entering the study
• Body mass index ≥25 kg/m2
• Diabetes treated with oral medications and/or GLP-1 receptor agonists and/or tirzepatide
• No modifications of diabetes treatment in the previous 3 months
• HbA1c between 7.5% and 10% (both inclusive)
• Oral and written informed consent for participation

Exclusion Criteria:

• Type 1 diabetes, gestational diabetes, other specific types of diabetes
• HbA1c >10.0%
• Treatment with insulin
• Previous use of any continuous glucose monitoring system
• GFR <30 ml/min
• Acute infections, acute diabetes complications and/or unplanned hospitalisations in the previous month
• Use of steroids or immunosuppressive medications in the previous 3 months
• Chemotherapy, radiotherapy, immune therapy in the previous 3 months
• Pregnancy and/or breastfeeding
• Skin lesions or dermatological conditions preventing proper sensor insertion
• Cognitive impairment and/or other conditions preventing proper use of continuous glucose monitoring system
• Lack of consent for the use of continuous glucose monitoring system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous glucose monitoring; Dexcom One+ continuous glucose monitoring system	Device: Continuous glucose monitoring; Participants will be randomized to use Dexcom One+ continuous glucose monitoring system for 12 weeks, with control visits every four weeks.
Other: Self-monitoring of blood glucose	Device: Self-monitoring of blood glucose; Participants will be randomized to continue self-monitoring of blood glucose with a glucose meter as per usual practice, with control visits every four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in time in range	Observed change in time in range (70-180 mg/dl) from baseline to week 12 in the group using CGM system compared to the group using SMBG.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Observed change in the percentage of glycated haemoglobin (HbA1c) from baseline to week 12.	Week 12
Change in TITR	Observed change in time in tight range (TITR; 70-140 mg/dl) from baseline to week 12.	Week 12
Change in TAR	Observed change in time above range (TAR; >180 mg/dl) from baseline to week 12.	Week 12
Change in TBR	Observed change in time below range (TBR; <70 mg/dl) from baseline to week 12.	Week 12
Change in CV	Observed change in glycaemic variability assessed with coefficient of variation (CV) from baseline to week 12.	Week 12
Change in body weight (kg)	Observed change in body weight from baseline to week 12.	Week 12
Change in markers of early vascular disease	Observed change in the concentrations of circulating markers of subclinical vascular disease: oxLDL, VCAM-1, ICAM-1, E-selectin, interleukin 6, interleukin 18 from baseline to week 12.	Week 12
Change in diabetes distress: DDS	Observed change in diabetes distress measured with DDS questionnaire from baseline to week 12. DDS is a 17-item questionnaire assessing diabetes distress over the previous month. Scores <2 points indicates no/little distress, 2-2.9 points - moderate distress, and ≥3 points - high distress.	Week 12
Change in PHQ-9	Observed change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to week 12. PHQ-9 is a 9-item questionnaire for screening, diagnosing, monitoring and measuring the severity of depression. Total score: 0-27 points; higher scores reflect greater severity of depressive symptoms.	Week 12
Change in quality of life: WHOQOL-BREF questionnaire	Observed change in abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire from baseline to week 12. Total score: 0-100 points; higher scores reflect higher quality of life.	Week 12
Change in sleep quality: PSQI	Observed change in sleep quality measured with Pittsburgh Sleep Quality Index (PSQI) from baseline to week 12. Total score: 0-21 points; a score greater than 5 indicates significant sleep difficulties.	Week 12
Change in TIR after completing the intervention	Observed change in time in range (TIR; 70-180 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up).	Week 24
Change in HbA1c after completing the intervention	Observed change in the percentage of glycated haemoglobin (HbA1c) from week 12 (end of intervention) to week 24 (post-intervention follow-up).	Week 24
Change in TITR after completing the intervention	Observed change in time in tight range (TITR; 70-140 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up).	Week 24
Change in TAR after completing the intervention	Observed change in time above range (TAR; >180 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up).	Week 24
Change in TBR after completing the intervention	Observed change in time below range (TBR; <70 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up).	Week 24
Change in CV after completing the intervention	Observed change in glycaemic variability assessed with coefficient of variation (CV) from week 12 (end of intervention) to week 24 (post-intervention follow-up).	Week 24
Change in markers of early vascular disease after completing the intervention	Observed change in the concentrations of circulating markers of subclinical vascular disease: oxLDL, VCAM-1, ICAM-1, E-selectin, interleukin 6, interleukin 18 from week 12 (end of intervention) to week 24 (post-intervention follow-up).	Week 24

Collaborators and Investigators

• Sponsor: Medical University of Bialystok
• Collaborators: Diabetes Poland
• Investigators: Principal Investigator: Anna Krentowska, MD, PhD, Medical University of Bialystok

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: October 30, 2026
• First Submitted That Met QC Criteria: October 30, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: October 30, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: type 2 diabetes; continuous glucose monitoring; non-insulin treated type 2 diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Continuous Glucose Monitoring; Blood Glucose Self-Monitoring
• Other Study ID Numbers: APK.002.300.2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No