Clinical Trial Details

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

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Trial Information

Broad Health Condition Metabolic and Endocrine

Specific Health ConditionDiabetes

Trial FocusTreatment

Recruitment statusCompleted

Recruitment Details
Recruitment State
NSW,SA,WA,VIC

Hospital
Princess Margaret Hospital - Subiaco
Womens and Childrens Hospital - North Adelaide
The Royal Childrens Hospital - Parkville
John Hunter Children's Hospital - New Lambton
The Children's Hospital at Westmead - Westmead
Perth Children's Hospital - Nedlands


Postcode
6008 - Subiaco
5006 - North Adelaide
3052 - Melbourne University
2305 - New Lambton
2145 - Westmead
6009 - Nedlands

Anticipated date of first participant enrolment20/03/2017

Anticipated date of last participant enrolment20/03/2017

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Trial summary

BACKGROUND: Hybrid closed-loop (HCL) insulin delivery, with automatic glucose sensing and insulin delivery reducing patient intervention, offers the potential to improve glycaemic control compared to conventional therapy in patients with type 1 diabetes. Superior glucose control has been demonstrated with lower rates of hypoglycaemia in many in-clinic studies, diabetes camp studies, hotel studies, and now in the first emerging short term outpatient studies using HCL systems. 
The primary rationale is to assess glycaemic control with the use of the HCL system versus standard therapy (either injections or standard pump therapy), including time in target range, as well as glycaemic excursions either hypoglycaemia or hyperglycaemia. We will explore the impact of this system on fear of hypoglycaemia and quality of life and other psychological measures. We seek to quantify the economic impact of HCL compared to standard therapy for translational purposes.

AIM: To compare the proportion of time spent in target glycaemic range (sensor glucose level 3.9 - 10 mmol/l) while using HCL or using standard therapy (MDI and CSII).

METHOD: Multi-centre randomized controlled trial in 160 patients aged 12 – 25 years with type 1 diabetes, comparing HCL with standard therapy (MDI or CSII) for 6 months.

OUTCOMES: The primary outcome is the difference in the proportion of time the sensor glucose level is in target range (3.9–10 mmol/L) during HCL insulin delivery vs standard therapy (MDI and CSII), measured 23-26 weeks post-randomisation.
Eligibility

Key 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

Minimum age12 Years

Maximum age25 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key 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
3	Oral 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
6	Uncontrolled 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
11	Inability 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
Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Telethon Kids Institute
Primary Sponsor Address: Telethon Kids Institute Perth Children's Hospital Northern Entrance 15 Hospital Avenue Nedlands WA 6009
Primary Sponsor Country: Australia

Trial IDACTRN12616000753459

UTN.U1111-1183-7153

Contact person for information and recruitmentProf
Timothy Jones
Department of Endocrinology & Diabetes Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
+61 8 64565033

Further information iconTim.Jones@health.wa.gov.au
Australia