Clinical trial NCT02294370: Variation of Glucose Values at Early Stages of Diabetes - Continuous Glucose Monitoring
Official title: Glucose Excursions at Early Stages of Diabetes, MOSAIC Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
continuous glucose monitoring
Lead sponsor: Folkhälsan Researech Center
Sponsor class: OTHER
Collaborators: name: Medtronic
name: University of Padova
name: Universidad Politecnica de Madrid
name: University of Pavia
name: Fondazione Salvatore Maugeri
name: Asociación Española Para el Desarrollo de la Epidemiologia Clínica
name: Lund University
name: Soluciones Tecnologias para la Salud y el Bienestar SA
name: National Technical University of Athens
First posted: 2014-11-19
Enrollment: 62
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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-Botnia Study in Finland. The Botnia Study and the PPP-Botnia Study are population based studies investigating type 2 diabetes in western Finland.

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.

Eligibility criteria: 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

Primary outcomes:
measure: glucose levels in tissue fluid
timeFrame: continuous monitoring for 1 week
Secondary outcomes:
measure: capillary glucose
timeFrame: 4 times a day for 1 week
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Folkhälsan Research Center
Study officials:
affiliation: Folkhalsan
name: Tiinamaija Tuomi, MD,lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soliman A, DeSanctis V, Yassin M, Elalaily R, Eldarsy NE. Continuous glucose monitoring system and new era of early diagnosis of diabetes in high risk groups. Indian J Endocrinol Metab. 2014 May;18(3):274-82. doi: 10.4103/2230-8210.131130.
citation: Wang C, Lv L, Yang Y, Chen D, Liu G, Chen L, Song Y, He L, Li X, Tian H, Jia W, Ran X. Glucose fluctuations in subjects with normal glucose tolerance, impaired glucose regulation and newly diagnosed type 2 diabetes mellitus. Clin Endocrinol (Oxf). 2012 Jun;76(6):810-5. doi: 10.1111/j.1365-2265.2011.04205.x.