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

NCT02294370 | Completed

• 1 other identifier: Botnia012014
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetes; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• glucose levels in tissue fluid

  continuous glucose monitoring system

  continuous monitoring for 1 week

Secondary Outcomes (1)

• capillary glucose

  4 times a day for 1 week

Study Arms (1)

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)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Folkhälsan Researech Center: lead
• Medtronic: collaborator
• University of Padova: collaborator
• Universidad Politecnica de Madrid: collaborator
• University of Pavia: collaborator
• Fondazione Salvatore Maugeri: collaborator
• Asociación Española Para el Desarrollo de la Epidemiologia Clínica: collaborator
• Lund University: collaborator
• Soluciones Tecnologias para la Salud y el Bienestar SA: collaborator
• National Technical University of Athens: collaborator

Study Sites (1)

Folkhälsan Research Center

Helsinki, Finland

Location

Related 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.

  PMID: 24944918 BACKGROUND

• 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.

  PMID: 21854404 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tiinamaija Tuomi, MD,lecturer

  Folkhalsan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 19, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

FI (1)