Rule-Based Closed Loop System for Type 1 Diabetes Control

This study has been completed.
Sponsor:
Information provided by:
Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT01614496
First received: June 7, 2012
Last updated: September 23, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Other: Algorithm for insulin administration

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Corporacion Parc Tauli:

Primary Outcome Measures:
  • Time spent with glucose in the target range [ Designated as safety issue: Yes ]

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Autonomous system neuropathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614496

Locations
Spain
Endocrinology and Nutrition Department. Corporació Sanitària i Universitària Parc Taulí
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
  More Information

No publications provided by Corporacion Parc Tauli

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01614496     History of Changes
Other Study ID Numbers: PS09/01255
Study First Received: June 7, 2012
Last Updated: September 23, 2013
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014