Evaluation of the Impact of Exercise on the Performance of an Artificial Pancreas

Not Applicable

Completed

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

• Registration Number: ACTRN12615000137594
• Lead Sponsor: St Vincents Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

Age > 18 years
-Type 1 Diabetes (confirmed by fasting C-peptide level < 50 pmol/L)
-Insulin pump therapy for at least 6 months
-HbA1c < 9.0%
-Experience with a glucose sensor
-Established insulin pump therapy parameters
-Ability to insert/change sensor
-Ability to undertake exercise as per protocol

Exclusion Criteria

-Requiring > 150 units of insulin/day
-Diabetic ketoacidosis within the past 4 weeks
-Hypoglycaemic unawareness (Gold score >4) while on Sensor Augmented Pump Therapy (SAPT) or > 2 severe hypoglycaemic episodes within the last 12 months
-Pregnancy
-Renal impairment (eGFR < 60ml/min/1.73m2)
-Current or recent (<4 weeks) oral or inhaled steroid therapy
-Dermatological conditions involving the region of device insertion
-Ischaemic heart disease or peripheral vascular disease precluding exercise
-Physical limitations (e.g. impaired vision) that would compromise operation of the Closed Loop system

Study & Design

• Study Type: Interventional
• Study Design: Not specified