Efficacy of Closed-Loop Strategy With and Without a Learning Component in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp
Diabetes, Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Diabetes focused on measuring diabetes, type 1 diabetes, diabetes mellitus, pediatrics, diabetes camp
Eligibility Criteria
Inclusion Criteria:
- Males and females between 8 and 21 years old.
- Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- The participant will have been on insulin pump therapy for at least 3 months.
- HbA1c ≤ 11%.
Exclusion Criteria:
- Participants who cannot or are unwilling to use NovoRapid (Aspart) insulin or Humalog (Lispro) insulin for the duration of the study.
- Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with the study protocol or with team's recommendations (e.g. not willing to use trial pump, etc.).
Sites / Locations
- Camp Carowanis
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Closed-loop therapy
Closed-loop therapy with learning module
Participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be determined by the camp's physicians. The research staff will update the pump's settings to reflect the physician's recommendations at the beginning of the closed-loop therapy, and each time the physicians update the study parameters. The closed-loop therapy will last 2 days (48 hours).
participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be computed by the learning algorithm and updated daily. The learning algorithm runs on a computer of the research staff members and requires patient data to calculate the optimal basal rates and ICR. Each day, the research staff members will upload patient data onto the computer, run the leaning algorithm, and update the pump parameters to reflect the recommendations computed by the learning algorithm. The closed-loop therapy with the learning module will last 8 days (192 hours).