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Trial registered on ANZCTR


Registration number
ACTRN12614001005640
Ethics application status
Approved
Date submitted
4/09/2014
Date registered
17/09/2014
Date last updated
9/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
In clinic evaluation of an "artificial pancreas" for the management of type 1 diabetes, when possible hypoglycaemia causing scenarios are simulated.
Scientific title
In clinic evaluation of a closed loop insulin delivery system using the Minimed 670g insulin pump, under hypoglycaemic stimuli including an over reading glucose sensor and exercise, in patients with type 1 diabetes aged 12 - 50 years old, with assessment of the incidence of hypoglycaemic events (plasma glucose level <3.5mmol/L)
Secondary ID [1] 285287 0
nil
Universal Trial Number (UTN)
U1111-1161-2020
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 292955 0
Hypoglycaemia 293052 0
Condition category
Condition code
Metabolic and Endocrine 293250 293250 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this interventional study, we will study patients with type 1 diabetes. They will be wearing a closed loop or 'artificial pancreas' system, which consists of an insulin pump with a mathematical algorithm that adjusts insulin according to real time continuous glucose monitoring from a glucose sensor. We will use the Minimed 670g insulin pump containing the algorithm, and enlite III glucose sensor.
The closed loop system will be fitted by the research team (research nurse, and doctor). The insulin pump and glucose sensor is worn as usual (external hardware, with subcutaneous infusion, and glucose sensor).
The observational period will be four consecutive days and three nights and will occur in-clinic, during whcih the closed loop system is used continuously.
On day 1 the participants will wear the closed loop system, and learn how to use it.
On day 2 we will calibrate the glucose sensor so that it over reads the glucose value by 30%
On day 3, we will continue to have the glucose sensor over read by 30% and participants will be asked to exercise by cycling on a stationary ergometer at moderate intensity (50 - 60% of VO2 max) for 45 minutes.
On day 4 the glucose sensor will be changed just like in normal clinical practice, and will be recalibrated to read normally.

As this study is conducted in clinic, all of the study protocol will be monitored and adhered to.
Intervention code [1] 290188 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293100 0
Hypoglycaemic events, defined by plasma glucose <3.5mmol/L. This will tested by taking blood from an IV cannula and testing on YSI laboratory equipment at the bedside. This is the gold standard for blood glucose measurement.
Timepoint [1] 293100 0
YSI plasma glucose will be measured hourly during waking hours and 2 hourly during sleep, throughout the 4 days and 3 nights. If plasma glucose is <4mmol/L, samples will be taken every 20 minutes. If plasma glucose is <3.5mmol/l, participants will be given hypoglycaemia treatment. If plasma glucose is <4.0 but >3.5mmol/L and the participant is symptomatic for hypoglycaemia, they will be given hypo treatment. If plasma glucose is <2.8mmol/L and the system is delivering closed loop, the system will be closed down, participants given hypo treatment, and only restarted when YSI plasma glucose is >4mmol/L
Secondary outcome [1] 310337 0
time spent in in euglycaemic range of 4 - 10mmol/L of plasma blood glucose. This will tested by taking blood from an IV cannula and testing on YSI laboratory equipment at the bedside. This is the gold standard for blood glucose measurement.
Timepoint [1] 310337 0
YSI plasma glucose will be measured hourly during waking hours and 2 hourly during sleep, throughout the 4 days and 3 nights. If plasma glucose is <4mmol/L, samples will be taken every 20 minutes. If plasma glucose is <3.5mmol/l, participants will be given hypoglycaemia treatment. If plasma glucose is <4.0 but >3.5mmol/L and the participant is symptomatic for hypoglycaemia, they will be given hypo treatment. If plasma glucose is <2.8mmol/L and the system is delivering closed loop, the system will be closed down, participants given hypo treatment, and only restarted when YSI plasma glucose is >4mmol/L

Eligibility
Key inclusion criteria
1. Age 12-50 years with type 1 diabetes
2. Duration of diabetes at least 12 months
3. On insulin pump therapy for at least 6 months
4. Carbohydrate counting
5. Using bolus calculator function
6. HbA1C<9%
Minimum age
12 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy
2.Any alcoholic or substance abuse
3.Undergoing treatment for psychological illness
4.Any additional condition(s) that in the investigator’s opinion would warrant exclusion from the study or prevent the subject from completing the study
5.Participants unable to comply with V02 max exercise testing and moderate exercise for medical or any other reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be enrolled after being recruited. All participants will we allocated the same treatment modality. There is no concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There is no randomization, so sequence will be as participants are recruited
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
This is a pilot study with no formal testable hypothesis. Therefore there will be no statistical methods used. Hypoglycaemia events will be counted, and explored with reference to timing of exercise, meal boluses, and insulin delivery by the algorithm. There will be no interim analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2966 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 8674 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 289909 0
Charities/Societies/Foundations
Name [1] 289909 0
Princess Margaret Hospital Foundation
Address [1] 289909 0
GPO box D184, Perth WA 6008
Country [1] 289909 0
Australia
Primary sponsor type
Individual
Name
Dr Martin de Bock
Address
Princess Margaret Hospital
Roberts Road
Subiaco
Perth 6008
Western Australia
Country
Australia
Secondary sponsor category [1] 288597 0
Individual
Name [1] 288597 0
Professor Tim Jones
Address [1] 288597 0
Princess Margaret Hospital
Roberts Road
Subiaco 6008
Western Australia
Country [1] 288597 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291628 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 291628 0
GPO box D184
Perth
WA 6840
Ethics committee country [1] 291628 0
Australia
Date submitted for ethics approval [1] 291628 0
01/09/2014
Approval date [1] 291628 0
16/10/2014
Ethics approval number [1] 291628 0
2014092EP

Summary
Brief summary
This study will let us explore the safety of a closed loop for the management system that is designed for unmonitored home use. It is possible that if the system is stressed, that hypoglycaemia can still happen. For example during and after exercise, or if the glucose sensor is over reading. We will simulate these possibilites while participants are in a hospital system and are closely monitored. This will help us learn and improve the system, and educate participants in the future, when the device is used in the community.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51234 0
Dr Martin de Bock
Address 51234 0
Princess Margaret Hospital
Roberts Road
Subiaco Perth WA 6008
Country 51234 0
Australia
Phone 51234 0
+61 8 93407915
Fax 51234 0
Email 51234 0
martin.debock@health.wa.gov.au
Contact person for public queries
Name 51235 0
Dr Martin de Bock
Address 51235 0
Princess Margaret Hospital
Roberts Road
Subiaco
Perth WA 6008
Country 51235 0
Australia
Phone 51235 0
+61 8 93407915
Fax 51235 0
Email 51235 0
martin.debock@health.wa.gov.au
Contact person for scientific queries
Name 51236 0
Dr Martin de Bock
Address 51236 0
Princess Margaret Hospital
Roberts Road
Subiaco
Perth WA 6008
Country 51236 0
Australia
Phone 51236 0
+61 8 93407915
Fax 51236 0
Email 51236 0
martin.debock@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary