An interventional study of Continuous glucose monitoring and Self-monitoring of blood glucose in Type 2 Diabetes, sponsored by Medical University of Bialystok. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Medical University of Bialystok · Not applicable, Interventional, and Treatment
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Medical University of Bialystok is the lead sponsor of 72 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dexcom One+ continuous glucose monitoring system
Device: Continuous glucose monitoring
Device: Self-monitoring of blood glucose
Participants will be randomized to use Dexcom One+ continuous glucose monitoring system for 12 weeks, with control visits every four weeks.
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.
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.
Time frame: Week 12
Change in HbA1c
Observed change in the percentage of glycated haemoglobin (HbA1c) from baseline to week 12.
Time frame: Week 12
Change in TITR
Observed change in time in tight range (TITR; 70-140 mg/dl) from baseline to week 12.
Time frame: Week 12
Change in TAR
Observed change in time above range (TAR; \>180 mg/dl) from baseline to week 12.
Time frame: Week 12
Change in TBR
Observed change in time below range (TBR; \<70 mg/dl) from baseline to week 12.
Time frame: Week 12
Change in CV
Observed change in glycaemic variability assessed with coefficient of variation (CV) from baseline to week 12.
Time frame: Week 12
Change in body weight (kg)
Observed change in body weight from baseline to week 12.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Week 24
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Medical University of Bialystok