Type 2 DiabetesNCT07919236
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
A study testing Continuous glucose monitoring and Self-monitoring of blood glucose in people with Type 2 Diabetes, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Continuous glucose monitoring and Self-monitoring of blood glucose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Bialystok, Department of Internal Medicine and Metabolic Diseases
Bialystok, 15-276
Anna Krentowska, MD, PhD, +48858317761, anna.krentowska@umb.edu.pl
Anna Krentowska, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Continuous glucose monitoring, Self-monitoring of blood glucose
- Keywords
- type 2 diabetes, continuous glucose monitoring, non-insulin treated type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
Participants will be randomized to use Dexcom One+ continuous glucose monitoring system for 12 weeks, with control visits every four weeks.
Self-monitoring of blood glucoseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Continuous glucose monitoring | Experimental | Dexcom One+ continuous glucose monitoring system Receives: Device: Continuous glucose monitoring |
| Self-monitoring of blood glucose | Other | Not described Receives: Device: Self-monitoring of blood glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (18)
Change in HbA1c
Observed change in the percentage of glycated haemoglobin (HbA1c) from baseline to week 12.
Measured: Week 12
Change in TITR
Observed change in time in tight range (TITR; 70-140 mg/dl) from baseline to week 12.
Measured: Week 12
Change in TAR
Observed change in time above range (TAR; >180 mg/dl) from baseline to week 12.
Measured: Week 12
Change in TBR
Observed change in time below range (TBR; <70 mg/dl) from baseline to week 12.
Measured: Week 12
Change in CV
Observed change in glycaemic variability assessed with coefficient of variation (CV) from baseline to week 12.
Measured: Week 12
Change in body weight (kg)
Observed change in body weight from baseline to week 12.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Poland
- Responsible party
- Principal investigator, Anna Krentowska, Medical University of Bialystok
- Investigators
- Anna Krentowska, MD, PhD, Principal investigator, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919236
- Sponsor's protocol ID
- APK.002.300.2025
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07919236
- Acronym / sponsor ID
- APK.002.300.2025
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, continuous glucose monitoring, non-insulin treated type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- Diabetes Poland
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring | Experimental | Device: Continuous glucose monitoringDexcom One+ continuous glucose monitoring system |
| Self-monitoring of blood glucose | Other | Device: Self-monitoring of blood glucose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoringParticipants will be randomized to use Dexcom One+ continuous glucose monitoring system for 12 weeks, with control visits every four weeks. | Device | Continuous glucose monitoring |
| Self-monitoring of blood glucoseParticipants will be randomized to continue self-monitoring of blood glucose with a glucose meter as per usual practice, with control visits every four weeks. | Device | Self-monitoring of blood glucose |
Primary outcome
Change in time in range
Time frame: Week 12
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.
18 secondary outcomes
Change in HbA1c
Time frame: Week 12
Change in TITR
Time frame: Week 12
Change in TAR
Time frame: Week 12
Change in TBR
Time frame: Week 12
Change in CV
Time frame: Week 12
Change in body weight (kg)
Time frame: Week 12
Change in markers of early vascular disease
Time frame: Week 12
Change in diabetes distress: DDS
Time frame: Week 12
Change in PHQ-9
Time frame: Week 12
Change in quality of life: WHOQOL-BREF questionnaire
Time frame: Week 12
Change in sleep quality: PSQI
Time frame: Week 12
Change in TIR after completing the intervention
Time frame: Week 24
Change in HbA1c after completing the intervention
Time frame: Week 24
Change in TITR after completing the intervention
Time frame: Week 24
Change in TAR after completing the intervention
Time frame: Week 24
Change in TBR after completing the intervention
Time frame: Week 24
Change in CV after completing the intervention
Time frame: Week 24
Change in markers of early vascular disease after completing the intervention
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Krentowska, MD, PhD principal investigator
Medical University of Bialystok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring and Self-monitoring of blood glucose in people with Type 2 Diabetes, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Krentowska, MD, PhD (+48858317761, anna.krentowska@umb.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time in range (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.