diabetes diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent, *Sub-optimal glycemic control (7.5%
Exclusion criteria
Exclusion criteria: Existing pregnancy or intention to conceive (as assessed by investigator). *Hearing or vision impairment so that glucose display and alarms cannot be recognized. *Three or more incidents in the last 12 months of severe hypoglycaemia with documented BG below 50mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether patients with diabetes mellitus can achieve better glycemic control as evidenced by a drop in HbA1c of 0.3%. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether patients with Type 1 diabetes mellitus in sub-optimal glycemic control using PRT compared to CSII alone with SMBG can achieve: *Reduced glycemic variability *Increased time in euglycemia *Reduced occurrence of hypo- and hyperglycemia *Improved treatment satisfaction *Reduced number of severe hypoglycemic events *Reduced number of diabetic ketoacidosis events *Changed treatment patterns: total daily insulin dose, basal patterns, basal/bolus ratio, number of daily boluses, types of boluses and timing *Reduced total number of admissions to emergency room and hospitalizations (number and duration) due to diabetic-related events *Reduced number of days missing school (children/adolescents) or missing work (adolescents/adults), due to diabetic-related events | — |
Countries
Netherlands
Outcome results
None listed