The effect of Hybrid Closed Loop insulin delivery on glucose control in patients with type 1 diabetes aged 12 - 25 years.

Phase 3

Completed

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

• Registration Number: ACTRN12616000753459
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-08
• Study Completion: 2020-03-31
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

1.Type 1 diabetes (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus) diagnosed at least 1 year ago
2.Fasting C peptide less than 0.1nmol/L (in the absence of hypoglycaemia)
3.Insulin regimen either: Multiple daily injections (MDI) more than 4 injections per day (greater than 3 rapid-acting insulin and 1 long-acting insulin), or insulin pump therapy (CSII) established for greater than 3months.
4.Aged 12- less than 25years
5.HbA1c less than 10.5%
6.Living in an area with internet and cellular phone coverage
7.English speaking

Exclusion Criteria

1.Chronic kidney disease (eGFR <45mL/min/1.73m2)
2.Use of any non-insulin glucose-lowering agent within the past 3 months
3Oral or injected steroid use within the past 3 months
4.Pregnancy, or planned pregnancy within study period
5.Uncontrolled coeliac disease (not following a gluten free diet), or other untreated malabsorption
6Uncontrolled thyroid disease
7.Clinically-significant gastroparesis
8.Uncontrolled hypertension (DBP >100 mmHg and/or SBP >160 mmHg)
9.History of myocardial infarction, severe uncontrolled heart failure, unstable angina, transient ischaemic attack (TIA), stroke, or thromboembolic disease in the past 3 months.
10.Poor visual acuity precluding use of the investigational technology
11Inability or unwillingness to meet protocol requirements (including carbohydrate-counting, CGM use as per allocated study group only).
12.Severe or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the ability to meet protocol requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The % time sensor glucose is in target range (3.9–10 mmol/L) during HCL insulin delivery vs standard therapy (MDI and CSII).<br><br>This outcome will be measured with a continuous glucose monitor, that is uploaded onto Medtronic software.[Measured for 3 weeks; 23-26 weeks post-randomisation. ]