The Low Glucose Suspend Trial - Comparing insulin pump therapy with low glucose suspend feature versus standard insulin pump therapy in patients with type 1 diabetes with hypoglycaemia unawareness

Phase 4

Recruiting

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

• Registration Number: ACTRN12610000024044
• Lead Sponsor: Princess Margaret Hospital for Children

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Duration of diabetes greater than or equal 12 months
On insulin pump therapy greater than or equal to 6 months
Glycated haemaglobin (HbA1C) between 6 and 8.5%
Impaired awareness of hypoglycaemia

Exclusion Criteria

Has adrenal insufficiency
Has growth hormone insufficiency
Has multiple pituitary hormone deficiency
Is pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the rate of severe and moderate hypoglycaemia. Severe hypoglycaemia is defined a hypoglycaemic event associated with loss of consciousness or seizure. Moderate hypoglycaemia is defined as a hypoglycaemic event requiring assistance. In addition to patient recall, moderate hypoglycaemia will be further quantified with the use of blinded CGMS before, during and after the intervention period. Moderate hypoglycaemia will be described as episodes of blood glucose level <2.8mmol/L.[Baseline, after 6 months on pump and after 6 months off pump]