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

Glucose Excursions at Early Stages of Diabetes, MOSAIC Prospective Study

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2

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 Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Folkhälsan Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

subjects at the early stages of diabetes; Subjects at the early stages of diabetes, individuals with impaired glucose tolerance (IGT, 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 same oral glucose tolerance test while not pregnant, n=50) with short duration (<3 years)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose levels in tissue fluid	continuous glucose monitoring system	continuous monitoring for 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
capillary glucose	for the calibration of the continuous glucose monitoring system	4 times a day for 1 week

Collaborators and Investigators

• Sponsor: Folkhälsan Researech Center
• Collaborators: Lund University; University of Padova; University of Pavia; Medtronic; Universidad Politecnica de Madrid; Fondazione Salvatore Maugeri; National Technical University of Athens; Asociación Española Para el Desarrollo de la Epidemiologia Clínica; Soluciones Tecnologias para la Salud y el Bienestar SA
• Investigators: Principal Investigator: Tiinamaija Tuomi, MD,lecturer, Folkhalsan

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: March 11, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: type 2 diabetes; continuous glucose monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Botnia012014