Status:
COMPLETED
Variation of Glucose Values at Early Stages of Diabetes - Continuous Glucose Monitoring
Lead Sponsor:
Folkhälsan Researech Center
Collaborating Sponsors:
Medtronic
University of Padova
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-75 years
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 ...
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 sy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02294370
Start Date
December 1 2013
End Date
June 1 2015
Last Update
March 14 2016
Active Locations (1)
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1
Folkhälsan Research Center
Helsinki, Finland