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Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format,

NCT03858062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-10-22

No results posted yet for this study

Summary

In previous studies, the investigators tested the feasibility of a bi-hormonal reactive closed loop system without mealtime announcement. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center (APPEL 1 and 2) as well as at the home of the patients (APPEL 3 and 4). After the APPEL 4 study some improvements have been made to the miniaturized prototype to allow patients to operate the system independently and additional risk control measures were included. The main objective of this study is to assess the efficacy of this improved closed loop system.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Insulin pump therapy (with or without glucose sensor)

Patients' own insulin pump with fast-acting insulin analog and optionally with own glucose sensor

DEVICE

Artificial pancreas (Inreda Diabetic)

Bi-hormonal reactive closed loop system without mealtime announcement

Sponsors & Collaborators

  • Rijnstate Hospital

    collaborator OTHER

  • Inreda Diabetic B.V.

    collaborator INDUSTRY

  • J.H. DeVries

    lead OTHER

Principal Investigators

  • J.H. DeVries, MD PhD · Academisch Medisch Centrum, Universiteit van Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-03-10
Primary Completion
2019-09-12
Completion
2019-09-12

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 NCT03858062 on ClinicalTrials.gov