In clinic evaluation of an artificial pancreas for the management of type 1 diabetes, when possible hypoglycaemia causing scenarios are simulated.

Phase 2

Completed

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

• Registration Number: ACTRN12614001005640
• Lead Sponsor: Dr Martin de Bock

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Age 12-50 years with type 1 diabetes
2. Duration of diabetes at least 12 months
3. On insulin pump therapy for at least 6 months
4. Carbohydrate counting
5. Using bolus calculator function
6. HbA1C<9%

Exclusion Criteria

1. Pregnancy
2.Any alcoholic or substance abuse
3.Undergoing treatment for psychological illness
4.Any additional condition(s) that in the investigator’s opinion would warrant exclusion from the study or prevent the subject from completing the study
5.Participants unable to comply with V02 max exercise testing and moderate exercise for medical or any other reason.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypoglycaemic events, defined by plasma glucose <3.5mmol/L. This will tested by taking blood from an IV cannula and testing on YSI laboratory equipment at the bedside. This is the gold standard for blood glucose measurement.[YSI plasma glucose will be measured hourly during waking hours and 2 hourly during sleep, throughout the 4 days and 3 nights. If plasma glucose is <4mmol/L, samples will be taken every 20 minutes. If plasma glucose is <3.5mmol/l, participants will be given hypoglycaemia treatment. If plasma glucose is <4.0 but >3.5mmol/L and the participant is symptomatic for hypoglycaemia, they will be given hypo treatment. If plasma glucose is <2.8mmol/L and the system is delivering closed loop, the system will be closed down, participants given hypo treatment, and only restarted when YSI plasma glucose is >4mmol/L]

Secondary Outcome Measures

Name	Time	Method
time spent in in euglycaemic range of 4 - 10mmol/L of plasma blood glucose. This will tested by taking blood from an IV cannula and testing on YSI laboratory equipment at the bedside. This is the gold standard for blood glucose measurement. [YSI plasma glucose will be measured hourly during waking hours and 2 hourly during sleep, throughout the 4 days and 3 nights. If plasma glucose is <4mmol/L, samples will be taken every 20 minutes. If plasma glucose is <3.5mmol/l, participants will be given hypoglycaemia treatment. If plasma glucose is <4.0 but >3.5mmol/L and the participant is symptomatic for hypoglycaemia, they will be given hypo treatment. If plasma glucose is <2.8mmol/L and the system is delivering closed loop, the system will be closed down, participants given hypo treatment, and only restarted when YSI plasma glucose is >4mmol/L]