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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Glucose Excursions at Early Stages of Diabetes, MOSAIC Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294370
• Other study ID #: Botnia012014
• Status: Completed
• Phase: N/A
• First received: November 17, 2014
• Last updated: March 11, 2016
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Folkhälsan Researech Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Finland	Folkhälsan Research Center	Helsinki

Sponsors (10)

Lead Sponsor	Collaborator
Folkhälsan Researech Center	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

Country where clinical trial is conducted

Finland, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose levels in tissue fluid	continuous glucose monitoring system	continuous monitoring for 1 week	No
Secondary	capillary glucose	for the calibration of the continuous glucose monitoring system	4 times a day for 1 week	No