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

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT02294370
• Lead Sponsor: Folkhälsan Researech Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-19
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
glucose levels in tissue fluid	continuous monitoring for 1 week	continuous glucose monitoring system

Secondary Outcome Measures

Name	Time	Method
capillary glucose	4 times a day for 1 week	for the calibration of the continuous glucose monitoring system

Trial Locations

Locations (1)

Folkhälsan Research Center; 🇫🇮 Helsinki, Finland