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

NCT02160275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-10-02

No results posted yet for this study

Summary

In previous studies, we tested the feasibility of a bi-hormonal closed loop system. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center as well as at the home of the patients. Glucose control with automated closed loop control was comparable to patient-managed open loop control.

The closed loop system has been further developed and miniaturized (from backpack to smartphone size) in order to interfere as little as possible with daily patient life. The aim of this trial is to assess the efficacy of the new prototype at the home of the patient. It is hypothesized that the closed loop system provides better glucose control than standard open loop therapy.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Artificial Pancreas (Inreda Diabetic BV)

Bi-hormonal reactive closed loop system without mealtime announcement, miniaturized prototype

DEVICE

Insulin pump therapy

Patients' own insulin pump with fast-acting insulin analog

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Rijnstate Hospital

    collaborator OTHER

  • J.H. DeVries

    lead OTHER

Principal Investigators

  • J. Hans 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
2014-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

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 NCT02160275 on ClinicalTrials.gov