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Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin

30. oktober 2026 opdateret af: Anna Krentowska, Medical University of Bialystok

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Polen
      • Bialystok, Polen, 15-276
        • Rekruttering
        • Medical University of Bialystok, Department of Internal Medicine and Metabolic Diseases
        • Kontakt:
        • Ledende efterforsker:
          • Anna Krentowska, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Continuous glucose monitoring

Dexcom One+ continuous glucose monitoring system
Enhed: Continuous glucose monitoring

Participants will be randomized to use Dexcom One+ continuous glucose monitoring system for 12 weeks, with control visits every four weeks.
Andet: Self-monitoring of blood glucose
Enhed: Self-monitoring of blood glucose

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in time in range
Tidsramme: 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.
Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in HbA1c
Tidsramme: Week 12

Observed change in the percentage of glycated haemoglobin (HbA1c) from baseline to week 12.
Week 12
Change in TITR
Tidsramme: Week 12

Observed change in time in tight range (TITR; 70-140 mg/dl) from baseline to week 12.
Week 12
Change in TAR
Tidsramme: Week 12

Observed change in time above range (TAR; >180 mg/dl) from baseline to week 12.
Week 12
Change in TBR
Tidsramme: Week 12

Observed change in time below range (TBR; <70 mg/dl) from baseline to week 12.
Week 12
Change in CV
Tidsramme: Week 12

Observed change in glycaemic variability assessed with coefficient of variation (CV) from baseline to week 12.
Week 12
Change in body weight (kg)
Tidsramme: Week 12

Observed change in body weight from baseline to week 12.
Week 12
Change in markers of early vascular disease
Tidsramme: Week 12

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.
Week 12
Change in diabetes distress: DDS
Tidsramme: Week 12

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.
Week 12
Change in PHQ-9
Tidsramme: Week 12

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.
Week 12
Change in quality of life: WHOQOL-BREF questionnaire
Tidsramme: Week 12

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.
Week 12
Change in sleep quality: PSQI
Tidsramme: Week 12

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.
Week 12
Change in TIR after completing the intervention
Tidsramme: Week 24

Observed change in time in range (TIR; 70-180 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24
Change in HbA1c after completing the intervention
Tidsramme: Week 24

Observed change in the percentage of glycated haemoglobin (HbA1c) from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24
Change in TITR after completing the intervention
Tidsramme: Week 24

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).
Week 24
Change in TAR after completing the intervention
Tidsramme: Week 24

Observed change in time above range (TAR; >180 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24
Change in TBR after completing the intervention
Tidsramme: Week 24

Observed change in time below range (TBR; <70 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24
Change in CV after completing the intervention
Tidsramme: Week 24

Observed change in glycaemic variability assessed with coefficient of variation (CV) from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24
Change in markers of early vascular disease after completing the intervention
Tidsramme: Week 24

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).
Week 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University of Bialystok

Samarbejdspartnere

Diabetes Poland

Efterforskere

  • Ledende efterforsker: Anna Krentowska, MD, PhD, Medical University of Bialystok

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. februar 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

30. oktober 2026

Først indsendt, der opfyldte QC-kriterier

30. oktober 2026

Først opslået (Faktiske)

5. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • APK.002.300.2025

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