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Trial registered on ANZCTR


Registration number
ACTRN12614000482662
Ethics application status
Approved
Date submitted
2/05/2014
Date registered
9/05/2014
Date last updated
12/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Closed loop insulin delivery and glucose control for type 1 diabetes, seven days and nights, hospital to home.
Scientific title
Performance of a closed loop insulin delivery system in patients with type 1 diabetes for seven days and nights in the hospital and home, compared to sensor augmented pump therapy, with respect to glycaemic outcomes.
Secondary ID [1] 284526 0
nil
Universal Trial Number (UTN)
U1111-1156-2402
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes 291782 0
Condition category
Condition code
Metabolic and Endocrine 292148 292148 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Closed loop insulin therapy (or artificial pancreas), compromising of a Medtronic Paradigm Veo insulin pump with continuous glucose sensor, an Android-based smartphone with the closed loop algorithm software, and a translator that translates messages between the phone and insulin pump. An insulin pump is an external device, which is already used by thousands of patients in the community. There is a small cannula placed subcutaneously through which the insulin is infused - and is attached to the insulin pump by plastic tubing. No anaesthetic is required. The infusion site lasts three days, before needing to be changed to a new site. The continous glucose sensor is a small plastic cannula inserted into the subcutaneous tissue - which then connects to an external transmitting device which communicates to the insulin pump via radiofrequency. A glucose sensor lasts a maximum of 6 days, and does not require an anaesthetic for insertion. Participants will spend this first 48 - 72 hours in hospital learning how to use the technology, before going home and completing a full 7 days. While at home patient will upload their insulin pump daily, and we will use remote monitoring of the smartphone for constant monitoring and checking of adherance. There will be a washout of at least 7 days between treatments.
Intervention code [1] 289287 0
Treatment: Devices
Comparator / control treatment
Sensor augmented insulin pump therapy (Medtronic Paradigm Veo insulin pump with continuous glucose sensor) with low glucose suspend function activated. An insulin pump is an external device, which is already used by thousands of patients in the community. There is a small cannula placed subcutaneously through which the insulin is infused - and is attached to the insulin pump by plastic tubing. No anaesthetic is required. The infusion site lasts three days, before needing to be changed to a new site. The continous glucose sensor is a small plastic cannula inserted into the subcutaneous tissue - which then connects to an external transmitting device which communicates to the insulin pump via radiofrequency. A glucose sensor lasts a maximum of 6 days, and does not require an anaesthetic for insertion. Participants will spend this first 48 - 72 hours in hospital learning how to use the technology, before going home and completing a full 7 days. While at home patient will upload their insulin pump daily sot hat we can monitor adherance.
Control group
Active

Outcomes
Primary outcome [1] 292025 0
time spent with sensor blood glucose between 3.9 – 10mmol/L
Timepoint [1] 292025 0
Calculated after 7 days
Primary outcome [2] 292026 0
hypoglycaemic events (sensor blood glucose <3.3mmol/L)
Timepoint [2] 292026 0
Count at the end of 7 days
Secondary outcome [1] 308023 0
nil
Timepoint [1] 308023 0
nil

Eligibility
Key inclusion criteria
Age 12-50 years with type 1 diabetes
Duration of diabetes at least 12 months
On insulin pump therapy for at least 6 months
Carbohydrate counting
Using bolus calculator function
HbA1C<9%
Minimum age
12 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Any alcoholic or substance abuse
Undergoing treatment for psychological illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary outcome in this study is the number of minutes per day spent in euglycaemia (BGL 3.9 – 10.0mmol/L). Using data from previous studies, patients using sensor augmented pump therapy spent a mean of 774 minutes per day (SD 232minutes) euglycaemic. We hypothesise that with closed loop this will increase by 30%. Using a paired t-test with within group correlation of 0.7, alpha at 0.05, we require 10 subjects to have 90% power to detect this increase. We will recruit 14 subjects to allow for participant drop-out.Treatment evaluation (Closed Loop Vs SAPT) will be based on the principal of intention to treat.
All statistical analysis will be two-sided and a 5% significance level will be maintained throughout the analyses. Linear mixed models will be used will be used to assess the main treatment effect accounting for the randomization sequence and time period. Continuous variables that are not normally distributed (or can not be transformed into a normally distributed variable) will be analysed using a Wilcoxon signed-rank test.
For missing glucose data a linear relationship will be assumed between data points when data omission is <2 hours. If there is a time period of >2hr with no blood glucose data, the between meal section of the day will be omitted from analysis (for example: breakfast to lunch, or lunch to dinner) and will be reported as insufficient data for analysis and study limitations during manuscript preparation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/05/2014
Actual
1/06/2014
Date of last participant enrolment
Anticipated
Actual
15/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2392 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 8043 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 289160 0
Charities/Societies/Foundations
Name [1] 289160 0
Juvenile Diabetes Research Foundation
Country [1] 289160 0
Australia
Funding source category [2] 289161 0
Commercial sector/Industry
Name [2] 289161 0
Medtronic
Country [2] 289161 0
United States of America
Primary sponsor type
Individual
Name
Martin de Bock
Address
Princess Margaret Hospital
1 Roberts Road
Subiaco
Perth 6008
Western Australia
Country
Australia
Secondary sponsor category [1] 287826 0
None
Name [1] 287826 0
Address [1] 287826 0
Country [1] 287826 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290933 0
Princess Margaret margaret Hospital Ethics Commitee
Ethics committee address [1] 290933 0
Princess Margaret Hospital
Roberts Road
Subiaco 6008
Western Australia
Ethics committee country [1] 290933 0
Australia
Date submitted for ethics approval [1] 290933 0
Approval date [1] 290933 0
01/05/2014
Ethics approval number [1] 290933 0
2014040EP

Summary
Brief summary
This is a randomized cross over trial. Patients with type 1 diabetes will have their glucose levels controlled by either a closed loop (artificial pancreas) system, or sensor augmented pump therapy with low glucose suspend. During closed loop patients will still use the bolus function of their pump for meals. The study will start in hospital for 2 days and nights, and then the participants will continue in the home for a further 5 days. Then, after a washout for at least a week, they will cross over to the opposite intervention for a further 7 day period. Our primary outcomes are the ammount of time spent euglycaemic (3.9 - 10mmol/L), and hypoglycaemic events (<3.3mmol/L). We will recruit 14 participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48046 0
Dr Martin de Bock
Address 48046 0
Princess Margaret Hospital
Department Paediatric and Endocrinology
1 Roberts Road
Subiaco
WA 6008
Country 48046 0
Australia
Phone 48046 0
+61 8 93407915
Fax 48046 0
Email 48046 0
[email protected]
Contact person for public queries
Name 48047 0
Martin de Bock
Address 48047 0
Princess Margaret Hospital
Department Paediatric and Endocrinology
1 Roberts Road
Subiaco
WA 6008
Country 48047 0
Australia
Phone 48047 0
+61 8 93407915
Fax 48047 0
Email 48047 0
[email protected]
Contact person for scientific queries
Name 48048 0
Martin de Bock
Address 48048 0
Princess Margaret Hospital
Department Paediatric and Endocrinology
1 Roberts Road
Subiaco
WA 6008
Country 48048 0
Australia
Phone 48048 0
+61 8 93407915
Fax 48048 0
Email 48048 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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