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Comparing two weight-based hypoglycaemia treatment protocols in children and teenagers using insulin pumps at the 2025 diabetes camp.

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000915550
Acronym
CE0.15G
Enrollment
50
Registered
2024-07-29
Start date
2025-01-06
Completion date
2025-01-10
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Hypoglycaemia is a critical concern for children with Type 1 diabetes, especially in active settings such as camps. This study aims to compare the efficacy of administering 0.15 grams of glucose/kg in children using automated insulin delivery (AID) pumps versus to the now standard protocol of using 0.3 grams of glucose/kg in children using non-automated insulin pumps during hypoglycaemic episodes. The goal is to determine the optimal treatment strategy that efficiently raises blood glucose levels without causing rebound hyperglycaemia, considering the different insulin management technologies.

Interventions

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

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

Sponsors

Capital & Coast Health, Wellington.
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training

Eligibility

Sex/Gender
All
Age
8 Years to 17 Years
Healthy volunteers
No

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.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026