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OpenTrials
Completed

NCT Number: NCT01614496

Rule-Based Closed Loop System for Type 1 Diabetes Control

The aim of the study is to assess the efficacy and safety of a Rule-based Closed Loop system, using subcutaneous way, for the overnight and prandial glucose control in type 1 diabetic subjects. Ten subjects will be enrolled and they will participate in a cross-over study with a control night, using their usual insulin pump pattern, and with a experimental night, being controlled for the closed loop system. Each night includes the overnight control and prandial control of the breakfast.

The system proposes an insulin dose every 5 minutes according with the value of glucose displayed by the continuous glucose monitoring system.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrinology and Nutrition Department. Corporació Sanitària i Universitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 Diabetes
  • Insulin pump treatment
  • Undetectable C-Peptide

Exclusion criteria

  • Autonomous system neuropathy

Treatment and study plan

Algorithm for insulin administration

Other

Primary outcomes

  1. Time spent with glucose in the target range

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Important dates

First posted
Jun 8, 2012
Registry last updated
Sep 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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