Assessing Closed-loop Insulin Delivery in Children With Type 1 Diabetes.

McGill University

Status: Terminated

Conditions: Diabetes Mellitus, Type 1

Treatments: Other: Insulin-alone closed-loop

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04612257

2020-5584

Details and patient eligibility

About

The objective of this clinical trial is to assess the safety of our insulin dosing algorithm in children with type 1 diabetes in a free-living study.

Full description

This is a preliminary pilot study to generate data to optimize an insulin dosing algorithm to regulate glucose levels in children with type 1 diabetes. There will be up to two 40-hour test in outpatient settings, in which we will assess an insulin dosing algorithm. The two tests will allow us to compare different tunings in the same patient (this allows easier interpretation of the data). For example, if in a specific participant, the dosing algorithm reduced insulin delivery at night to avoid low blood glucose levesl but led to a rebound increase in glucose levels, then a second visit with a slightly different target range will help answer this question. The objective of this clinical trial is to assess the safety of our algorithm in children with type 1 diabetes in a free-living study.

Enrollment: 10 patients

Sex: All

Ages: 2 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female children between 2 and 13 years of age.
2. Clinical diagnosis of type 1 diabetes mellitus (the diagnosis of type 1 diabetes is based on the investigator's judgment).
3. Using insulin pump therapy for at least 3 months
4. For participants aged 7-13 years: Total daily insulin dose ≤ 40 units and 0.5 ≥ units/kg/day. For participants aged 2-6 years: Total daily insulin dose [8, 40] units and 0.3 ≥ units/kg/day.
5. Most recent (in the last 6 months) HbA1c ≤ 12%.

Exclusion criteria

1. Using Medtronic 670G automated insulin delivery system (since participant's basal rates and insulin-to-carbohydrate ratios may reflect the use of 670G; generally overestimated by 20%).
2. Severe hypoglycaemia or ketoacidosis episode ≤ two months before admission.
3. Medical illness or other issues likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Insulin alone closed-loop

Experimental group

Description:

Insulin alone closed-loop algorithm in children with type 1 diabetes in a free-living study.

Treatment:

Other: Insulin-alone closed-loop