Diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Type 1 diabetes mellitus (as defined by the American Diabetes Association criteria) for >= 6 months - Intensive insulin regimen consisting of MDI (basal-bolus with > 3 injections/day) or CSII established for more than 3 months - Blood glucose control for >= 4 times per day, either using fingerprick measurements, FSL-FGM or rt-CGM established for more than 3 months - Age 18 to 75 years - HbA1c
Exclusion criteria
Exclusion criteria: - Oral of injected steroid using within the past 3 months - Pregnancy or planned pregnancy - Uncontrolled thyroid disease or uncontrolled hypertension - Poor visual acuity - Inability or unwillingness to meet the protocol requirements - Severe cognitive impairment - Any severe or uncontrolled medical or psychological condition which, in the opinion of the investigator, would compromise the ability to meet protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the difference in percentage of time in the hypoglycemic (defined as glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include changes in glucose control, sensor performance, changes in clinical parameters, PROs and PREs (including health related quality of life, treatment satisfaction, fear of hypoglycemia, diabetes distress and patient preference) during and between both treatment phases. | — |
Countries
Netherlands
Outcome results
None listed