The Performance of an Artificial Pancreas at Home in People With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title: The Impact of the Overnight Closed Loop System on Glycemia, Subsequent Day-time Metabolic Control, Insulin Delivery, Counter Regulatory Hormones, Sleep Quality, Cognition and Satisfaction With Treatment, Compared to Open Loop System (Sensor Augmented Pump Therapy) in Both the Clinical Trial Centre and in the Home Setting in Type 1 Diabetes

Status Completed

Clinical Trial Summary

The overall aim of the study is to evaluate the performance of Artificial Pancreas or Closed Loop Glucose-Sensing Insulin-Delivery system in comparison to current best available technology represented by Sensor Augmented Pump Therapy (SAPT) in patients with Type 1 Diabetes.

Clinical Trial Description

At present, decisions regarding insulin dosing are made by the patient with intermittent support from their medical team. Even with glucose sensor augmented insulin pump therapy (SAPT), representing the most advanced technology currently available, there are emotional and intellectual demands placed upon the patient with the most well-educated, intelligent and diligent patients often unable to perfectly match insulin delivery with their varying requirements. SAPT does improve glycaemia in comparison with insulin pump therapy alone though a significant proportion of patients will still not meet target HbA1c (<7.0%). A Closed Loop (CL) system whereby a computerised algorithm reviews continuous glucose information to determine a T1D patient's insulin requirements and controls insulin delivery will potentially have a major impact upon acute and chronic complications of diabetes as well as upon their quality of life. Overnight glycaemic control, without the added challenge of meals, physical activity and stress, is a realistic initial application of CL in clinical practice.

This study aims to evaluate insulin pump therapy with an overnight CL system in comparison with current best available technology represented by SAPT in Type 1 Diabetes (T1D) patients, in both hospital and then at home. Outcomes of interest will include metabolic control and performance of the Medtronic CL overnight system compared with SAPT (OL), in both the Clinical Trials Centre (CTC) and in the home setting; the relationship between night-time and day-time metabolic control with CL and OL and nocturnal clinical, hormonal and inflammatory factors that may influence subsequent daytime metabolic control; anti-insulin antibody titres and dissociation constants (Rd) upon CL algorithm performance; sleep quality, cognition, satisfaction with treatment and psychological parameters.

A two phase randomised crossover study design is to be employed with the first phase conducted for a single night in the clinical trials centre and the second phase over 5 days in an ambulatory setting. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

• NCT number: NCT02040571
• Study type: Interventional
• Source: St Vincent's Hospital Melbourne
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: December 2015