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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02294370
• Date of registration: 17/11/2014
• Prospective Registration: No
• Primary sponsor: Folkhälsan Researech Center
• Public title: Variation of Glucose Values at Early Stages of Diabetes - Continuous Glucose Monitoring
• Scientific title: Glucose Excursions at Early Stages of Diabetes, MOSAIC Prospective Study
• Date of first enrolment: December 2013
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02294370
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Finland

Contacts

• Name: Tiinamaija Tuomi, MD,lecturer
• Affiliation: Folkhalsan

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Primary Outcome(s)

glucose levels in tissue fluid [Time Frame: continuous monitoring for 1 week]

Secondary Outcome(s)

capillary glucose [Time Frame: 4 times a day for 1 week]

Secondary ID(s)

Botnia012014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Soluciones Tecnologias para la Salud y el Bienestar SA

Asociación Española Para el Desarrollo de la Epidemiologia Clínica

Lund University

National Technical University of Athens

University of Padova

Medtronic

University of Pavia

Fondazione Salvatore Maugeri

Universidad Politecnica de Madrid