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Completed

NCT Number: NCT02294370

Variation of Glucose Values at Early Stages of Diabetes - Continuous Glucose Monitoring

This study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. In addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Folkhälsan Research Center

Helsinki, Finland

About this study

Type 2 diabetes is a chronic disease of glucose metabolism leading to various disabling conditions. The onset of type 2 diabetes is a gradual shift from normal to abnormal, giving rarely noticeable symptoms at its early stages or even in later stages when damage has already been caused. Due to the gradual onset, the diagnosis is often delayed, and as much as half of the asymptomatic patients remain undetected. The diagnostic criteria for diabetes are based on artificial boundaries reflecting the risk of complications related to diabetes. The golden standard of diagnosis of diabetes is a 2 hours oral glucose tolerance test, which is both time consuming and costly. This study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. In addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with impaired glucose tolerance (2h plasma glucose during oral glucose tolerance test >7.8-11.1 mmol/l, n=50) or with type 2 diabetes (fasting plasma glucose > 7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria fulfilled in the same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years); 40 from Padova University Hospital, 60 from the Botnia Study or the PPP (Prevalence, Prediction, Prevention)-Botnia Study in Finland.
  • Age 40-75 years

Exclusion criteria

  • Medication with: insulin, glucagon-like peptide-1 (GLP-1)-analogues, sulphonylureas, oral corticosteroids, thyreostatic agents or thyroid hormone, luteinizing-hormone-releasing hormone (LHRH) analogues
  • Pregnancy
  • Known changes in retinal fundus photographs
  • Known, microalbuminuria
  • HbA1c >8%
  • Fasting plasma glucose >10 mmol/l
  • Medication with metformin, glitazones, gliptins (or acarbose) is allowed but gliptins and acarbose need to be stopped 2 days before testing and during the study

Treatment and study plan

Primary outcomes

  1. glucose levels in tissue fluid

    Time frame: continuous monitoring for 1 week

    continuous glucose monitoring system

Secondary outcomes

  1. capillary glucose

    Time frame: 4 times a day for 1 week

    for the calibration of the continuous glucose monitoring system

Sponsors and collaborators

Lead sponsor

Folkhälsan Researech Center

Other

Collaborators

  • Asociación Española Para el Desarrollo de la Epidemiologia Clínica
  • Fondazione Salvatore Maugeri
  • Lund University
  • Medtronic
  • National Technical University of Athens
  • Soluciones Tecnologias para la Salud y el Bienestar SA
  • Universidad Politecnica de Madrid
  • University of Padova
  • University of Pavia

Registry information

Official study title

Glucose Excursions at Early Stages of Diabetes, MOSAIC Prospective Study

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 19, 2014
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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