Rule-Based Closed Loop System for Type 1 Diabetes Control

September 23, 2013 updated by: Corporacion Parc Tauli

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.

Study Overview

Status

Completed

Conditions

Type 1 Diabetes

Intervention / Treatment

Other: Algorithm for insulin administration

Study Type

Interventional

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- Barcelona
  - Sabadell, Barcelona, Spain, 08208
    - Endocrinology and Nutrition Department. Corporació Sanitària i Universitària Parc Taulí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

Type 1 Diabetes
Insulin pump treatment
Undetectable C-Peptide

Exclusion Criteria:

Autonomous system neuropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time spent with glucose in the target range

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Capel I, Rigla M, Garcia-Saez G, Rodriguez-Herrero A, Pons B, Subias D, Garcia-Garcia F, Gallach M, Aguilar M, Perez-Gandia C, Gomez EJ, Caixas A, Hernando ME. Artificial pancreas using a personalized rule-based controller achieves overnight normoglycemia in patients with type 1 diabetes. Diabetes Technol Ther. 2014 Mar;16(3):172-9. doi: 10.1089/dia.2013.0229. Epub 2013 Oct 23.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Estimate)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

PS09/01255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.