Study of changes to insulin pump basal rates in type 1 diabetes

Phase 4

Completed

• Conditions: Metabolic and Endocrine - Diabetes; Type 1 diabetes

• Registration Number: ACTRN12612000449831
• Lead Sponsor: St Vincent's Hospital, Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to reach steady state circulating insulin levels following a change in basal insulin infusion rate. Insulin levels will be measured using plasma from venous blood for free insulin radioimmunoassay (plasma with insulin antibodies will be pre-treated with polyethylene glycol to precipitate bound insulin).[Insulin levels assessed for 5 hours after basal insulin infusion rate change (insulin levels tested 15-minutely over this period)]