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

NCT ID: NCT02294370

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-06-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: collaborator

Universidad Politecnica de Madrid

OTHER

Sponsor Role: collaborator

University of Pavia

OTHER

Sponsor Role: collaborator

Fondazione Salvatore Maugeri

OTHER

Sponsor Role: collaborator

Asociación Española Para el Desarrollo de la Epidemiologia Clínica

UNKNOWN

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: collaborator

Soluciones Tecnologias para la Salud y el Bienestar SA

UNKNOWN

Sponsor Role: collaborator

National Technical University of Athens

OTHER

Sponsor Role: collaborator

Folkhälsan Researech Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiinamaija Tuomi, MD,lecturer

Role: PRINCIPAL_INVESTIGATOR

Folkhalsan

Locations

Folkhälsan Research Center

Helsinki, , Finland

Countries

Finland

References

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.

Reference Type: BACKGROUND

PMID: 24944918 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21854404 (View on PubMed)

Other Identifiers

Botnia012014

Identifier Type: -

Identifier Source: org_study_id