Clinical trial NCT05543850: Portable Artificial Pancreas Applied for Youth and Adolescents
Official title: Portable Artificial Pancreas Applied for Youth and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Inreda Diabetic B.V.
Sponsor class: INDUSTRY
Collaborators: name: Stichting Robopump
name: Rijnstate ziekenhuis
name: Kinder Diabetes Centrum Nijmegen
First posted: 2022-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a monocenter, randomized cross-over trial. The total duration of the study will be three months: two weeks open loop control and 4-6 training days followed by a two-week closed-loop period, or vice versa, with at least 2 weeks in between.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the performance of a bi-hormonal reactive closed-loop system in adolscents with type 1 diabetes mellitus. The percentage of time spent in the target range (3.9-10.0 mmol/L) is the main outcome and will be compared between the bi-hormonal closed-loop system and the current treatment of the patients. Also, safety parameters, pharmacodynamics and patient reported outcomes (expectations, trust and treatment satisfaction scores) are compared.

This study is a monocenter, randomized, cross-over trial with 20 subjects. The subjects will be randomized to receive either the open-loop therapy or the closed-loop therapy for the first two-week study period and switch to the alternate treatment with at least two weeks in between.

Detailed description: Background of the study:

Inreda Diabetic B.V. (Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1. In previous studies, we tested the performance and safety of this bi-hormonal closed-loop system in an outpatient setting in patients with type 1 diabetes mellitus (T1DM) for a duration up to 2 weeks, leading to CE-marking of the system. The device is currently intended for insulin-dependent adult patients with diabetes. However, there is great need to improve glycaemic control in youth and adolescents with diabetes.

Objective of the study:

The main objective of this study is to determine the performance of the closed-loop system in adolescents with T1DM. Secondary objectives include: to assess the safety of the closed-loop system; to determine the time that the closed-loop algorithm is active; and to assess expectations and treatment satisfaction of the closed-loop system.

Study design:

This study is a monocenter randomized cross-over trial.

Study population:

The study population will comprise 20 patients with T1DM, between 12 and 18 years old, not having impaired awareness of hypoglycaemia, and who are treated with insulin therapy for at least 6 months. Patients receiving treatment with multiple daily injections (MDI) or continuous subcutaneous insulin injections (CSII), and in addition glucose monitoring using self-monitored blood glucose (SMBG), flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) are included into the study.

Intervention:

The intervention includes 2 weeks of closed-loop control with the artificial pancreas (AP) of Inreda Diabetic. The device uses 2 subcutaneous glucose sensors, 2 subcutaneous infusion sets, and incorporates 2 pumps and a reactive closed-loop algorithm. During 4-6 days before the intervention the patients receive training on the use of the closed-loop system and will start using the device under close supervision. The control arm (open loop treatment) consists of the patient's standard therapy at home for 2 weeks.

Main study parameters/endpoints:

Main study parameter is the percentage of time spent in the target range (3.9-10.0 mmol/L), which will be compared between the open and closed-loop periods for each patient.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 1 diabetes mellitus
* Twelve to eighteen years old;
* Treated with insulin therapy for at least 6 months;
* Willing and able to sign informed consent or to assent to study participation.

Exclusion Criteria:

* Impaired awareness of hypoglycaemia (score ≥ 4) according to Gold and/or Clarke questionnaire\[6,7\];
* BMI ≥ 35 kg/m2;
* Pregnancy and/or breastfeeding;
* HbA1c \> 97 mmol/mol (11.0%);
* Use of acetaminophen (paracetamol) during the open loop or closed-loop period,as this may influence the sensor glucose measurements;
* Limited ability to see, hear or feel the alarm signals of the closed-loop system;
* Unwillingness to act in response to the alarm signals;
* Living alone during the night during the closed-loop period (the patient may ask someone to stay over temporarily);
* Expected poor internet connectivity regarding 24/7 tele monitoring;
* Any condition that the local investigator feels would interfere with trial participation or evaluation of the results.

Primary outcomes:
measure: Time in range
timeFrame: 2 weeks
Secondary outcomes:
measure: Time in hypoglycemia 1
timeFrame: 2 weeks
measure: Time in hypoglycemia 2
timeFrame: 2 weeks
measure: Time in hyperglycemia 1
timeFrame: 2 weeks
measure: Time in hyperglycemia 2
timeFrame: 2 weeks
measure: Mean glucose concentration
timeFrame: 2 weeks
measure: Median glucose concentration
timeFrame: 2 weeks
measure: Glycemic variability - Coefficient of variation
timeFrame: 2 weeks
measure: Glycemic variability - Interquartile range
timeFrame: 2 weeks
measure: Mean glucose concentration during the day
timeFrame: 2 weeks
measure: Mean glucose concentration during the night (12PM - 6AM)
timeFrame: 2 weeks
measure: Median glucose concentration during the day (6AM - 12PM)
timeFrame: 2 weeks
measure: Median glucose concentration during the night (12PM - 6AM)
timeFrame: 2 weeks
measure: Time spent in hypoglycemia during the night
timeFrame: 2 weeks
measure: Time spent in hyperglycemia during the night
timeFrame: 2 weeks
measure: Time spent in euglycemia during the night
timeFrame: 2 weeks
measure: Time spent in hypoglycemia during the day
timeFrame: 2 weeks
measure: Time spent in hyperglycemia during the day
timeFrame: 2 weeks
measure: Time spent in euglycemia during the day
timeFrame: 2 weeks
measure: Algorithm active time
timeFrame: 2 weeks
measure: Expectations
timeFrame: 2 weeks
measure: Trust
timeFrame: 2 weeks
measure: Satisfaction
timeFrame: 2 weeks
Other outcomes:
measure: Gender
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Length
timeFrame: Baseline
measure: HbA1c plasma concentration
timeFrame: Baseline
measure: Current medication use
timeFrame: Baseline
measure: Insulin dose
timeFrame: 2 weeks
measure: Glucagon dose
timeFrame: 2 weeks
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
state: Gelderland
Study officials:
affiliation: Rijnstate ziekenhuis
name: Arianne Bon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: