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De impact van continue glucosemonitoring op glucosevariabiliteit en gewichtsverlies bij individuen met prediabetes en obesitas (CGM)

30 oktober 2026 bijgewerkt door: Zala Jenko Praznikar, University of Primorska

De Impact van Continue Glucose Monitoring op Gedragsverandering, Glucosevariabiliteit en Gewichtsverlies bij Personen met Prediabetes en Obesitas - een Gerandomiseerde Crossoverstudie

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.

Studie Overzicht

Toestand

Geschorst

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

34

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Slovenië
      • Izola, Slovenië, 6310
        • University of Primorska, Faculty of Health Sciences
      • Koper, Slovenië, 6000
        • Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia
      • Ljubljana, Slovenië, 1000
        • Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Adults aged 18-70 years.
  • BMI ≥ 27 kg/m² (overweight or obese).
  • Prediabetes, confirmed by:

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).

  • Stable body weight (±3 kg) in the last 3 months.
  • No current use of antidiabetic or weight-loss medications.
  • Willingness and ability to wear a CGM device as instructed.
  • Capacity to provide written informed consent.
  • Recruitment from the Diabetes Outpatient Clinic, Community Health Center Koper (identified and invited from the clinic's database).

Exclusion Criteria:

  • Diagnosis of type 1 or type 2 diabetes mellitus (fasting glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%).
  • Current or recent (within 3 months) use of:
  • Any antidiabetic medication (insulin, metformin, GLP-1RA, SGLT2i, etc.), or anti-obesity pharmacotherapy.
  • Pregnancy, breastfeeding, or planned pregnancy during the study period.
  • Severe chronic disease that could influence glucose metabolism or study participation (e.g., chronic liver disease, renal failure, active malignancy).
  • Endocrine disorders affecting metabolism (e.g., untreated thyroid disease, Cushing's syndrome).
  • Severe psychiatric illness or cognitive impairment limiting adherence or comprehension.
  • Use of medications known to affect glucose metabolism (e.g., corticosteroids, atypical antipsychotics).
  • Implanted electronic medical devices (e.g., pacemaker, defibrillator) that may interfere with CGM function.
  • Known allergy or skin reaction to CGM adhesives or device materials.
  • Participation in another interventional study within the previous 3 months.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Open CGM
Apparaat: 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.
Experimenteel: Geblindeerde CGM
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Glycemic Variability Assessed by Coefficient of Variation from CGM
Tijdsspanne: End of each 12-week CGM phase

Change in glucose coefficient of variation (CV%), calculated from CGM data, comparing open versus blinded CGM phases. Unit of Measure: Percentage (%)
End of each 12-week CGM phase
Postprandial Glucose Excursions Measured by CGM
Tijdsspanne: End of each 12-week CGM phase

Mean postprandial glucose excursion (PPGE) following habitual meals, derived from CGM data. Unit of Measure: mmol/L
End of each 12-week CGM phase
Change in Mean Daily Energy Intake
Tijdsspanne: End of each 12-week CGM phase

Change in mean daily caloric intake assessed using participant-completed food diaries. Unit of Measure: kcal/day
End of each 12-week CGM phase

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Time in Tight Range (3.9-7.8 mmol/L) Measured by Continuous Glucose Monitoring
Tijdsspanne: End of each 12-week CGM phase

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 (%)
End of each 12-week CGM phase
Change in Glycemic Variability Assessed by Standard Deviation from CGM
Tijdsspanne: End of each 12-week CGM phase

Change in standard deviation of interstitial glucose values derived from CGM data, comparing open versus blinded CGM phases. Unit of Measure: mmol/L
End of each 12-week CGM phase
Change in Continuous Overall Net Glycemic Action (CONGA) from CGM
Tijdsspanne: End of each 12-week CGM phase

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
End of each 12-week CGM phase
Change in Glycemic Complexity Assessed by Entropy-Based Indices from CGM
Tijdsspanne: End of each 12-week CGM phase

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
End of each 12-week CGM phase
Postprandial Incremental Area Under the Curve (iAUC) Derived from CGM
Tijdsspanne: End of each 12-week CGM phase

Incremental area under the glucose curve (iAUC) following habitual meals, calculated from CGM data. Unit of Measure: mmol/L·min
End of each 12-week CGM phase
Adherence to Continuous Glucose Monitoring
Tijdsspanne: End of each 12-week CGM phase

Adherence to CGM use, defined as percentage of days with valid CGM data and frequency of data uploads. Unit of Measure: Percentage (%)
End of each 12-week CGM phase
Change in Fasting Plasma Glucose
Tijdsspanne: Baseline; end of each 12-week CGM phase

Change in Fasting Plasma Glucose measured in mmol/L by biochemical analyzer.
Baseline; end of each 12-week CGM phase
Change in Body Weight
Tijdsspanne: Baseline; end of each 12-week CGM phase

Change in Body Weight (in kg) from baseline to week twelve (of each CGM phase).
Baseline; end of each 12-week CGM phase
Change in Physical Activity Assessed by IPAQ Short Form
Tijdsspanne: Baseline; end of each 12-week CGM phase

Physical activity assessed using the International Physical Activity Questionnaire (IPAQ) short form, reported as total MET-minutes per week.
Baseline; end of each 12-week CGM phase
Change in Health Status Assessed by EQ-VAS
Tijdsspanne: Baseline; end of each 12-week CGM phase

Change in Health Status Assessed by EQ-VAS index score (0-100; higher scores indicate better perceived health).
Baseline; end of each 12-week CGM phase
Change in Glycated Hemoglobin (HbA1c)
Tijdsspanne: Baseline; end of each 12-week CGM phase

Change in Glycated Hemoglobin (HbA1c) measured in % (according to The National Glycohemoglobin Standardization Program - NGSP)
Baseline; end of each 12-week CGM phase

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Primorska

Medewerkers

University Medical Centre Ljubljana
Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia

Onderzoekers

  • Hoofdonderzoeker: Ajda Urbas, MD, Diabetes Outpatient Clinic, Community Health Center Koper, Slovenia
  • Studie stoel: Mojca Jensterle Sever, PhD, University Medical Centre Ljubljana, Department Of endocrinology and diabetes, Medical Faculty, University of Ljubljana
  • Studie stoel: Zala Jenko Pražnikar, PhD, University of Primorska, Faculty of Health Sciences

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 december 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 juni 2028

Studieregistratiedata

Eerst ingediend

26 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 februari 2026

Eerst geplaatst (Werkelijk)

20 februari 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CGM

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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