Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effekten av kontinuerlig glukoseovervåking på glukosevariasjon og vekttap hos personer med prediabetes og fedme (CGM)

30. oktober 2026 oppdatert av: Zala Jenko Praznikar, University of Primorska

Effekten av kontinuerlig glukosemonitorering på atferdsendring, glukosevariabilitet og vekttap hos personer med prediabetes og fedme – en randomisert krysset studie

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.

Studieoversikt

Status

Suspendert

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

34

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Åpen CGM
Enhet: 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.
Eksperimentell: Blindet CGM
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Glycemic Variability Assessed by Coefficient of Variation from CGM
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Time in Tight Range (3.9-7.8 mmol/L) Measured by Continuous Glucose Monitoring
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Primorska

Samarbeidspartnere

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

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. desember 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

26. januar 2026

Først innsendt som oppfylte QC-kriteriene

12. februar 2026

Først lagt ut (Faktiske)

20. februar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CGM

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere