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Portable Artificial Pancreas Applied for Youth and Adolescents

NCT05543850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-08-14

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Bi-hormonal closed-loop control

During bi-hormonal closed-loop control insulin and glucagon are administered to the developed closed-loop algorithm. Aditionally, patients will wear a blinded Dexcom G6 for data collection during the closed loop period.

DEVICE

Open-loop control

During open-loop control the patients will use their usual diabetes therapy. Aditionally, patients will wear a blinded Dexcom G6 for data collection during the open loop period.

Sponsors & Collaborators

  • Stichting Robopump

    collaborator UNKNOWN

  • Rijnstate ziekenhuis

    collaborator UNKNOWN

  • Kinder Diabetes Centrum Nijmegen

    collaborator UNKNOWN

  • Inreda Diabetic B.V.

    lead INDUSTRY

Principal Investigators

  • Arianne Bon, MD, PhD · Rijnstate ziekenhuis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2023-05-19
Completion
2023-05-19

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543850 on ClinicalTrials.gov