Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000915550p
Ethics application status
Not yet submitted
Date submitted
5/06/2024
Date registered
29/07/2024
Date last updated
29/07/2024
Date data sharing statement initially provided
29/07/2024
Date results provided
29/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing two weight-based hypoglycaemia treatment protocols in children and teenagers using insulin pumps at the 2025 diabetes camp.
Scientific title
Comparative Efficacy of 0.15 Grams of Glucose in Children Using Automated Insulin Delivery Pumps vs 0.3 Grams of Glucose in Children Using Non-Automated Pumps for Treating Hypoglycaemia at a Diabetes Camp
Secondary ID [1] 312257 0
nil
Universal Trial Number (UTN)
Trial acronym
CE0.15G
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypoglycaemia 333974 0
Type 1 Diabetes 333975 0
Condition category
Condition code
Metabolic and Endocrine 330642 330642 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a non-randomized, interventional trial conducted at the 2025 summer camp for children with Type 1 diabetes in accordance with the Diabetes New Zealand Camping Guidelines (2020). The study will include two experimental groups based on the type of insulin delivery system they use. The participants are Children and Teenagers aged 8 -17 with a diagnosis of Type 1 diabetes attending the camp. Each participant will use either Automated Insulin Delivery pumps (AID) or non-automated insulin pumps or multiple daily injections (MDI) to manage their Type 1 diabetes.. The two interventional groups are those participants using either the Multiple Daily Injection (MDI) and non Automated Insulin Delivery (AID) system regimens or the AID system. The exclusion criteria are children with other chronic illnesses or those using medications that interfere with glucose metabolism. A total of 50 participants will be recruited and assigned to groups Camp Group Leaders for supervision as per normal diabetes camp guidelines ( please see Guidelines for Camp Leaders and DNZ Camping Guidelines). Participants will be assigned to receive 0.15 grams/kg of glucose hypoglycaemia treatment group for those using AID pumps or 0.3 grams/kg of glucose (for those using non- AID pumps or MDI regimen - upon experiencing a hypoglycaemic episode (blood glucose level less than 4.0mmol/L) - please see Diabetes Camp Hypoglycaemia and Hyperglycaemia Guidelines. Each participant will have their individualised quantity of glucose preparation calculated by the Principal Investigator before the beginning of the camp and each Group Leader will be trained the week before camp (please see 2022 Camp Group Leader Guidelines. Participants weight will be obtained from the last diabetes clinic letter of 2024. Baseline data collection is a normal part of diabetes camp procedure and recorded on their specific camp files and blood glucose recording charts. Blood glucose levels will be monitored regularly throughout the camp using continuous glucose monitoring (CGM) systems and finger-prick testing as prescribed. Hypoglycaemia episodes will be identified using CGM and confirmed with finger-prick check. Upon confirmation of hypoglycaemia, participants will receive the assigned (individualised) dose of glucose based on their insulin delivery system. Blood glucose levels will be rechecked at 15 minutes post-administration - according to the attached Diabetes Camp Hypoglycaemia and Hyperglycaemia Guidelines and the time of the day.

The Primary Outcome will be the time to normalization of blood glucose levels (less than 4.0mmol/L). The Secondary Outcomes is the incidence of rebound hyperglycaemia (blood glucose greater than 10mmol/L within 2 hours post-treatment), adverse effects, and practicality of administration
Intervention code [1] 328964 0
Treatment: Other
Comparator / control treatment
All participants have Type 1 diabetes. The control group are those on multiple daily injections or non-sensor augmented pumps using the standard protocol 0. 0.3 grams glucose/ kg of body weight to treat a hypoglycaemia episode. The treatment group are those participants on Sensor Augmented pumps and will receive the recommended reduced dose of glucose treatment - we hypothesise the is be 0.15 grams/kg of body weight.
Control group
Dose comparison

Outcomes
Primary outcome [1] 338386 0
The time to normalization of blood glucose levels (less than 4.0mmol/L).
Timepoint [1] 338386 0
Timing will commence once the child/teen has begun to consume the glucose and will stop once the blood glucose has reached 4.0mmol/L . Blood glucose leads sensor glucose so timing will not be reliant on sensor glucose reaching above 4.0mmol/L. Finger prick samples will be taken at 15 minute intervals.
Secondary outcome [1] 435729 0
The incidence of rebound hyperglycaemia (blood glucose greater than 10mmol/L within 2 hours post-treatment).
Timepoint [1] 435729 0
Following completion of the camp.

Eligibility
Key inclusion criteria
All participants selected by diabetes New Zealand selection committee being eligible to attend the 2025 children's and teenager's diabetes camp at El Rancho, Waikanae , NZ.
Minimum age
8 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The data (The normal camp recording sheets) will be analyzed using ‘R’ software. Descriptive statistics will summarize baseline characteristics. Independent t-tests will compare the mean time to normalization between the two groups. Chi-square tests will assess differences in the incidence of rebound hyperglycaemia and adverse effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
10/01/2025
Actual
Date of last data collection
Anticipated
10/01/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 26358 0
New Zealand
State/province [1] 26358 0
Wellington
Country [2] 26359 0
New Zealand
State/province [2] 26359 0
Wellington

Funding & Sponsors
Funding source category [1] 316637 0
Charities/Societies/Foundations
Name [1] 316637 0
Diabetes New Zealand
Country [1] 316637 0
New Zealand
Primary sponsor type
Hospital
Name
Capital & Coast Health, Wellington.
Address
Country
New Zealand
Secondary sponsor category [1] 319266 0
None
Name [1] 319266 0
Address [1] 319266 0
Country [1] 319266 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315419 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 315419 0
Ethics committee country [1] 315419 0
New Zealand
Date submitted for ethics approval [1] 315419 0
27/08/2024
Approval date [1] 315419 0
Ethics approval number [1] 315419 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134646 0
Mr Lindsay McTavish
Address 134646 0
Health New Zealand - Te Whata Ora Capital & Coast Health; 66 Ridderford St; Newtown; Wellington 6021.
Country 134646 0
New Zealand
Phone 134646 0
+64 021544586
Fax 134646 0
Email 134646 0
[email protected]
Contact person for public queries
Name 134647 0
Lindsay McTavish
Address 134647 0
Health New Zealand - Te Whata Ora Capital & Coast Health; 66 Ridderford St; Newtown; Wellington 6021.
Country 134647 0
New Zealand
Phone 134647 0
+64 021544586
Fax 134647 0
Email 134647 0
[email protected]
Contact person for scientific queries
Name 134648 0
Lindsay McTavish
Address 134648 0
Health New Zealand - Te Whata Ora Capital & Coast Health; 66 Ridderford St; Newtown; Wellington 6021.
Country 134648 0
New Zealand
Phone 134648 0
+64 021544586
Fax 134648 0
Email 134648 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will only be available to parents, study team and clinical people responsible for the care of the participant.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.