diabetes mellitus
Conditions
Interventions
The intervention is the use of the 'free style navigator continuous glucose
monitoring device' with an number of facilities:
1: 'On line' display of the glucose level in the insterstitial fluid ever
Sponsors
Abbott
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Type 1 diabetes mellitus since at least 2 jaar Age at least 18 years
Exclusion criteria
Exclusion criteria: 1: Severe hypoglycaemia during the last 4 months before the start of the study 2: Medical problems (co-morbidity, organ complications of diabetes) of medication that would potentially jeopardize the participation of the patient in the eyes of the treating physician and/or the investigator 3: Pregnancy or planned pregnancy during the study period 4: Participation in another study with a comparable device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study outcome is the degree of glycaemic variability, comparing the blinded period (days 0 tot 20) with the open period (days 20 to 60). Glucose variability is a mathematical outcome, derived from the glucose data from the first and second period of the Navigator-device. This outcome parameter is exemplified on page 27 of the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameter is the experiences of the users with this new device. Patients fill in a questionnaire after completion of the study. | — |
Countries
Netherlands
Outcome results
None listed