An interventional study of Continuous Glucose Monitoring (CGM) in Pre Diabetic and Obesity & Overweight, sponsored by University of Primorska. Suspended at 3 sites in Slovenia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University of Primorska · Not applicable, Interventional, and Prevention
The study has been temporarily suspended pending approval from the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP). The need for this additional regulatory approval was identified following communication with JAZMP.
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.
Prediabetes and obesity are major contributors to the development of type 2 diabetes and its complications. Early intervention focused on glycemic control and lifestyle modification is essential to prevent disease progression. Continuous glucose monitoring (CGM) provides real-time insight into glucose dynamics and may support behavioral change; however, evidence is limited on how access to glucose data influences sustained lifestyle modification and metabolic outcomes in individuals with prediabetes.
The primary objectives are to assess the impact of real-time (open) versus blinded CGM on (1) glycemic variability using sensitive dynamic metrics, and (2) behavioral changes, including dietary habits and physical activity, in adults with prediabetes and overweight or obesity.
Secondary objectives include evaluating the effects of CGM on anthropometric and metabolic parameters, biochemical and physiological markers of metabolic control, participant experience and acceptability of CGM, sustainability of lifestyle changes, and associations between glycemic variability and cardiometabolic risk reduction.
This prospective, randomized, open-label, blinded crossover interventional study will evaluate the effects of CGM on behavior, glycemic variability, and weight loss in adults with prediabetes and obesity (BMI ≥ 27 kg/m²). Thirty participants will be recruited from the Diabetes Outpatient Clinic of the Community Health Center Koper. After screening and a 10-day blinded CGM run-in period, participants will be randomized (1:1) to one of two sequences: (A) open CGM for 12 weeks followed by a 30-day washout and 12 weeks of blinded CGM, or (B) blinded CGM for 12 weeks followed by washout and 12 weeks of open CGM. Participants will attend baseline and follow-up visits for anthropometric, biochemical, and behavioral assessments during each study phase.
793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.
This study's planned enrollment of 34 is below the median of 56 across 661 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →University of Primorska is the lead sponsor of 56 studies on the registry; 7 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.
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).
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.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Device: Continuous Glucose Monitoring (CGM)
Device: Continuous Glucose Monitoring (CGM)
Use of a continuous glucose monitoring system to measure interstitial glucose levels. During the open CGM phase, participants have real-time access to glucose data; during the blinded CGM phase, glucose data are masked from participants.
Change in Glycemic Variability Assessed by Coefficient of Variation from CGM
Change in glucose coefficient of variation (CV%), calculated from CGM data, comparing open versus blinded CGM phases. Unit of Measure: Percentage (%)
Time frame: End of each 12-week CGM phase
Postprandial Glucose Excursions Measured by CGM
Mean postprandial glucose excursion (PPGE) following habitual meals, derived from CGM data. Unit of Measure: mmol/L
Time frame: End of each 12-week CGM phase
Change in Mean Daily Energy Intake
Change in mean daily caloric intake assessed using participant-completed food diaries. Unit of Measure: kcal/day
Time frame: End of each 12-week CGM phase
Change in Time in Tight Range (3.9-7.8 mmol/L) Measured by Continuous Glucose Monitoring
Change in percentage of time glucose values are within the tight range of 3.9-7.8 mmol/L, derived from continuous glucose monitoring (CGM) data, comparing open versus blinded CGM phases. Unit of Measure: Percentage (%)
Time frame: End of each 12-week CGM phase
Change in Glycemic Variability Assessed by Standard Deviation from CGM
Change in standard deviation of interstitial glucose values derived from CGM data, comparing open versus blinded CGM phases. Unit of Measure: mmol/L
Time frame: End of each 12-week CGM phase
Change in Continuous Overall Net Glycemic Action (CONGA) from CGM
Change in CONGA index calculated from CGM glucose profiles, reflecting short-term glycemic variability, comparing open versus blinded CGM phases. Unit of Measure: mmol/L
Time frame: End of each 12-week CGM phase
Change in Glycemic Complexity Assessed by Entropy-Based Indices from CGM
Change in glucose pattern complexity assessed using entropy-based indices derived from CGM data, comparing open versus blinded CGM phases. Unit of Measure: Unitless index
Time frame: End of each 12-week CGM phase
Postprandial Incremental Area Under the Curve (iAUC) Derived from CGM
Incremental area under the glucose curve (iAUC) following habitual meals, calculated from CGM data. Unit of Measure: mmol/L·min
Time frame: End of each 12-week CGM phase
Adherence to Continuous Glucose Monitoring
Adherence to CGM use, defined as percentage of days with valid CGM data and frequency of data uploads. Unit of Measure: Percentage (%)
Time frame: End of each 12-week CGM phase
Change in Fasting Plasma Glucose
Change in Fasting Plasma Glucose measured in mmol/L by biochemical analyzer.
Time frame: Baseline; end of each 12-week CGM phase
Change in Body Weight
Change in Body Weight (in kg) from baseline to week twelve (of each CGM phase).
Time frame: Baseline; end of each 12-week CGM phase
Change in Physical Activity Assessed by IPAQ Short Form
Physical activity assessed using the International Physical Activity Questionnaire (IPAQ) short form, reported as total MET-minutes per week.
Time frame: Baseline; end of each 12-week CGM phase
Change in Health Status Assessed by EQ-VAS
Change in Health Status Assessed by EQ-VAS index score (0-100; higher scores indicate better perceived health).
Time frame: Baseline; end of each 12-week CGM phase
Change in Glycated Hemoglobin (HbA1c)
Change in Glycated Hemoglobin (HbA1c) measured in % (according to The National Glycohemoglobin Standardization Program - NGSP)
Time frame: Baseline; end of each 12-week CGM phase
Plan to share: Undecided
No publications or documents are linked to this record.
The study has been temporarily suspended pending approval from the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP). The need for this additional regulatory approval was identified following communication with JAZMP.
The study has been temporarily suspended pending approval from the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP). The need for this additional regulatory approval was identified following communication with JAZMP.
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 ↗
This study is suspended, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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