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Trial registered on ANZCTR


Registration number
ACTRN12622000455763
Ethics application status
Approved
Date submitted
14/03/2022
Date registered
23/03/2022
Date last updated
16/06/2024
Date data sharing statement initially provided
23/03/2022
Date results information initially provided
16/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of closed loop technology in young children with Type 1 Diabetes Aged 2-7 - A feasibility study
Scientific title
Assessment of the feasibility of using closed loop technology in young children with Type 1 Diabetes Aged 2-7
Secondary ID [1] 306383 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
HyCLIP - Feasibility
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 325211 0
Condition category
Condition code
Metabolic and Endocrine 322608 322608 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This sub-study of the HyCLIP-RCT trial assesses the feasibility of the Hybrid Closed Loop system in young children with Type 1 diabetes (T1D). It is a 6-week prospective, single-arm study with a 2-week run-in period, assessing the clinical experience of young children with T1D in free-living conditions with the Advanced Hybrid Closed Loop System (AHCL) and identifying barriers that may affect the optimal conduct of the HyCLIP-RCT study.

The AHCL system comprises of the Medtronic MiniMed 780G insulin pump containing the closed loop algorithm, a next generation glucose sensor and a glucose sensor transmitter. The MiniMed 780G Pump works with the following major components: 1) Continuous Glucose Monitoring (CGM) that includes the Guardian Link (3) Transmitter that is connected to the Guardian Sensor (3) to receive sensor glucose values at 5 minute intervals; 2) blood glucose meter that will be used to calibrate the sensor and has the ability to send blood glucose values wirelessly as a convenience to the user; 3) MiniMed Mobile App to allow upload of data wirelessly to the CareLink therapy management software; and 4) Pump Accessory devices to deliver insulin (infusion sets and reservoirs). The MiniMed 780G system has the capability to operate in Manual Mode or SmartGuard Mode (also referred to as AHCL or Auto Mode).
• Manual Mode is when insulin delivery is the responsibility of the user and will be based on the user defined basal rates. Meal boluses are the responsibility of the user. Manual Mode also has the capability of suspending insulin if the sensor glucose is predicted to fall below predefined threshold values (also referred to as Suspend on Low/Suspend Before Low)
• SmartGuard is when the insulin delivery is being commanded by the AHCL algorithm to a set threshold of 5.5 mmol/L, 6.1 mmol/L, and 6.7 mmol/L as determined by the user. The AHCL algorithm will calculate the insulin dose at five-minute intervals, based on CGM data, in order to achieve glycaemic control throughout the day. Meal boluses are the responsibility of the user.

Participants and their parents will be educated on the use of Auto Mode (which will adjust the insulin delivery based on their determined set threshold of either 5.5 mmol/L, 6.1 mmol/L, or 6.7 mmol/L) during a 2-hour pump and CGM training.

The information session will cover:
- Instructions for pump upload
- Instructions to log hypoglycaemia and hyperglycaemia in the record book provided
- Instructions to link the participant's CGM to the Medtronic 780G pump
Sensor naïve individuals will have familiarisation phase of 7 to 10 days to get used to wearing a sensor.

The blood glucose threshold will be set at the discretion of the participant's endocrinologist. The AHCL algorithm will calculate the insulin dose at five-minute intervals based on their continuous glucose monitoring (CGM) data, in order to achieve glycaemic control throughout the day. Participants will still need to bolus for meals like standard pump therapy; hence described as a hybrid closed loop system. The advanced algorithm will be more robust in correcting hyperglycaemia as compared to the currently available Medtronic 670G system. The modifications to the closed loop algorithm include the addition of adjustable target set points (5.5 mmol/L, 6.1 mmol/L, and 6.7 mmol/L), an auto correction bolus without user input or acknowledgement and fine tuning of safeguards in order to reduce auto mode exits and improve user experience. The system will also have an additional Bluetooth capability which will make it possible to control the glucose level via a phone app and is therefore more suitable for this young cohort.

Participants will have a 2-week run-in phase (±1 week) during which participants will use the system in Manual Mode followed by a 6-week study phase (±1 week) during which AutoMode is enabled.

All visits will be conducted by a Diabetes educator with the supervision of an endocrinologist. Participants will have weekly communication via phone call or email for support in between clinic visits. Glucose levels will be remotely monitored continuously 24/7 by both caregivers/parents and study staff via CareConnect App. A default urgent low setting alert will be set at 3mmol/L and caregivers/parents will be contacted by the study staff if this alert persists for more than 20 minutes (an expected recovery time following hypoglycaemia treatment). Frequency of communication will increase pas per clinical need. Adverse events, if any, will be logged at each visit.
Intervention code [1] 322817 0
Treatment: Devices
Intervention code [2] 323002 0
Prevention
Intervention code [3] 323003 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330634 0
Overall clinical experience with the device - Measured by recruitment and retention rates and a list of difficulties/solutions encountered during this feasibility phase determined by entries recorded in the log book provided and from discussion with the diabetes educator.
Timepoint [1] 330634 0
Baseline and at the end of the feasibility study (8 weeks post-enrolment)
Secondary outcome [1] 407430 0
Glycaemic control

Assessed using percentage HbA1c from blood samples, percentage time in range (3.9 - 10mmol/L) from closed loop monitor analytics, and coefficient of variation of sensor glucose values from closed loop monitor analytics.
Timepoint [1] 407430 0
Baseline and at the end of the feasibility study (8 weeks post-enrolment)
Secondary outcome [2] 407431 0
Likelihood of uptake and engagement with the Device (MiniMed 780G pump) -
Assessed using frequency of device setting adjustments for insulin carbohydrate ratio and active insulin time.
Timepoint [2] 407431 0
Baseline and at the end of the feasibility study (8 weeks post-enrolment)

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. Continuous Subcutaneous Insulin Infusion (CSII) therapy for at least 3 months
3. Age 2 to 7 years (inclusive)
4. Total daily insulin of greater or equal 8 units/day in last 2 weeks
5. Participant and parent willing to follow study instructions
6. Living in an area with internet and cellular coverage
Minimum age
2 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Commenced CGM in the 3 months prior to screening visit
2. Using advanced hybrid closed loop system: Control IQ
3. Uncontrolled coeliac disease
4. Uncontrolled thyroid disease
5. Inability or unwillingness to meet protocol requirements
6. Unwilling to perform 3 to 4 finger stick blood glucose measurements daily
7. Use of Hydroxyurea medication
8. Poor vision (of primary caregiver) precluding the use of investigational technology

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
No statistical tests will be conducted with the difficulties encountered/solutions identified at the weekly meetings of the study team. Rather, all difficulties encountered will be discussed on a weekly basis and be collated into a single table at the end of the feasibility phase. This information will be used to design the manual of operations for the larger RCT.
Recruitment rate will be presented as a rate of recruitment per week and retention rate will be presented as a proportion of recruited participants that continued to wear the device to the end of the feasibility phase.
The mean, standard deviation, median, and interquartile range will be presented for insulin to carbohydrate ratio,

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2022
Actual
8/06/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
24/01/2023
Date of last data collection
Anticipated
1/06/2023
Actual
23/03/2023
Sample size
Target
12
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21966 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 37062 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 310737 0
Charities/Societies/Foundations
Name [1] 310737 0
Juvenile Diabetes Research Foundation (JDRF) Australia
Country [1] 310737 0
Australia
Funding source category [2] 311012 0
Commercial sector/Industry
Name [2] 311012 0
Medtronic Diabetes
Country [2] 311012 0
United States of America
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
Perth Children's Hospital
15 Hospital Avenue
Nedlands 6009 WA
Country
Australia
Secondary sponsor category [1] 311959 0
None
Name [1] 311959 0
Address [1] 311959 0
Country [1] 311959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310313 0
Child and Adolescent Health Service HREC
Ethics committee address [1] 310313 0
Perth Children’s Hospital
15 Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 310313 0
Australia
Date submitted for ethics approval [1] 310313 0
19/05/2020
Approval date [1] 310313 0
11/12/2020
Ethics approval number [1] 310313 0
RGS0000003688

Summary
Brief summary
This feasibility study is an 8-week, prospective, single-arm study, in free-living conditions in children aged 2 to 7 years with Type 1 Diabetes on insulin pump therapy. The participants will use the MiniMed 780G Advanced Hybrid Closed Loop system in Manual Mode for 2 weeks followed by 6 weeks in SmartGuard mode. It will establish the clinical parameters and settings of the device to test for the effectiveness of the device in this group.

The primary aim of the 6-week feasibility phase is to increase the clinical experience with the device and to identify logistical barriers that may affect the optimal conduct of further studies.

Secondary aims of the feasibility phase are:
1. To assess the likelihood of uptake and engagement with the device (MiniMed 780G Pump)
2. To gather further estimates of glycaemic control metrics in children with T1D
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117214 0
Prof Timothy W Jones
Address 117214 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 117214 0
Australia
Phone 117214 0
+61 864565033
Fax 117214 0
Email 117214 0
tim.jones@health.wa.gov.au
Contact person for public queries
Name 117215 0
Miss Julie Dart
Address 117215 0
Telethon Kid's Institute
Northern Entrance
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 117215 0
Australia
Phone 117215 0
+61 864564608
Fax 117215 0
Email 117215 0
julie.dart@health.wa.gov.au
Contact person for scientific queries
Name 117216 0
Dr Mary Abraham
Address 117216 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 117216 0
Australia
Phone 117216 0
+61 864565027
Fax 117216 0
Email 117216 0
mary.abraham@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data will be shared as per contract with funding bodies, JDRF and Medtronic Diabetes, as well as sponsoring institution's regulation and policies according to GCP.
When will data be available (start and end dates)?
At completion of the study and publications of primary and secondary outcomes - tentative after July 2023 and up to 15 years thereafter.
Available to whom?
Investigators external to the trial will need to submit an application to request for participant data.
Guidelines for application will be made available closer to study completion.
Available for what types of analyses?
Translational analyses with proven scientific and ethical rigor identified through the application process.
How or where can data be obtained?
Please submit a data request application to Children's Diabetes Centre at Telethon Kids Institute via email diabetes.research@health.wa.gov.au. Guidelines for application will be made available closer to study completion.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15415Study protocol  mary.abraham@health.wa.gov.au 383539-(Uploaded-09-03-2023-14-43-57)-Study-related document.pdf
15416Ethical approval  julie.dart@health.wa.gov.au 383539-(Uploaded-09-03-2023-14-53-43)-Study-related document.pdf
15466Ethical approval    383539-(Uploaded-19-03-2022-01-16-08)-Study-related document.pdf
23795Study protocol  julie.dart@health.wa.gov.au 383539-(Uploaded-28-05-2024-18-36-51)-HyCLIP Protocol V9 07Nov2022.pdf
23796Ethical approval  julie.dart@health.wa.gov.au 383539-(Uploaded-28-05-2024-18-37-40)-20221213_RGS3688 HREC Approved amendment Protocol v9.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYeshttps://doi.org/10.1089/dia.2023.0508 Submitted V1.pdf

Documents added automatically
No additional documents have been identified.