The impact of exercise and exercise-related reductions in insulin pump basal delivery on blood insulin levels in type 1 diabetes

Phase 4

Completed

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

• Registration Number: ACTRN12613000581763
• 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: 2013-05-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

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 factor, established basal insulin delivery profile including overnight basal rate between 0.50-1.40 units per hour (without significant overnight variation), able to tolerate moderate-intensity exercise.

Exclusion Criteria

Symptoms of ischaemic heart disease or known cardiac condition precluding moderate-intensity exercise, ischaemic changes on electrocardiogram, episode of diabetic ketoacidosis or severe hypoglycaemia (requiring third party assistance) within the last month, pregnant or planned pregnancy within study period, renal impairment (estimated glomerular filtration rate <60 mL per minute), body mass index <18 or >32, adverse skin condition in the area of cannula or device placement, allergy to insulin aspart.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The impact of moderate-intensity exercise, associated with a prior reduction in basal insulin delivery, on changes in circulating insulin levels. Plasma free insulin levels will be measured via radioimmunoassay (plasma will be pre-treated with polyethylene glycol to precipitate bound insulin when antibodies are present).[Plasma insulin levels will be assessed at 15 minute intervals from 60 minutes prior to the basal insulin rate reduction until 210 minutes after the reduction.]