None listed
Conditions
Brief summary
Insulin pumps are increasingly being used to deliver insulin for people with type 1 diabetes. The two main components of insulin pump delivery are firstly "bolus" insulin, used with meals or to correct high glucose levels, and secondly "basal" insulin which provides the background insulin requirements of the individual. The rate of basal insulin delivered can be adjusted with the pump, and this may vary according to the time of day, stress, illness or exercise. Information regarding changes in the basal insulin infusion rate to best match an individual's insulin requirement is essential to guide clinical decision-making. The purpose of this study is to determine the time to reach steady state circulating insulin levels after a clinically-relevant increase and also a clinically-relevant reduction in basal insulin infusion rates delivered by insulin pumps to adults with type 1 diabetes.
Interventions
Insulin pump therapy with aspart insulin. Insulin pumps are small computerised devices delivering subcutaneous rapid-acting insulin continuously, accurately and flexibly.
Intervention - following a stable baseline subcutaneous insulin infusion rate for 6 hours, a clinically-relevant change is to be made to the basal insulin infusion rate. For the next 5 hours, circulating insulin levels are to be tested 15-minutely to assess the time to reach steady state circulating insulin levels. At the firs
Insulin pump therapy with aspart insulin. Insulin pumps are small computerised devices delivering subcutaneous rapid-acting insulin continuously, accurately and flexibly. Intervention - following a stable baseline subcutaneous insulin infusion rate for 6 hours, a clinically-relevant change is to be made to the basal insulin infusion rate. For the next 5 hours, circulating insulin levels are to be tested 15-minutely to assess the time to reach steady state circulating insulin levels. At the first study visit, the basal insulin rate change is to be an increment, and at the second study visit (1-6 weeks after the first visit) the rate change is to be a reduction. The total dose of subcutaneous insulin infused during the 5-hour intervention period will be between 2 units and 10 units (depending on the insulin requirements of the individual). Standardised insulin pumps and aspart insulin will be used for each study visit, and participants will resume their usual insulin and insulin pump at the conclusion of each visit.
Sponsors
St Vincent's Hospital, Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed