ACTRN12612000449831CompletedPhase 4
Time to reach steady state insulin levels following a clinically-relevant increment and reduction in subcutaneous basal insulin infusion rates administered via an insulin pump in adults with type 1 diabetes
St Vincent's Hospital, Melbourne0 sites12 target enrollmentStarted: April 20, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •Clinical diagnosis of type 1 diabetes, managed with insulin pump therapy for minimum of 3 months, established insulin:carbohydrate ratio, established insulin sensitivity, established basal insulin delivery profile including a rate of 0.60-1.40 units per hour overnight (without significant variation during this period).
Exclusion Criteria
- •Pregnancy or planned pregnancy, episode of diabetic ketoacidosis or major hypoglycaemia (requiring third party assistance) within the last 3 months, significant renal impairment (estimated glomerular filtration rate <40 mL per min), unresolved adverse skin condition in the area of cannula or device placement, body mass index >30 or <18, allergy to insulin aspart.
Investigators
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