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NCT01614496 Clinical Trial

Rule-Based Closed Loop System for Type 1 Diabetes Control

Type 1 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01614496
Other study ID # PS09/01255
Secondary ID
Status Completed
Phase N/A
First received June 7, 2012
Last updated September 23, 2013

Study information
Verified date June 2013
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Type 1 Diabetes

- Insulin pump treatment

- Undetectable C-Peptide

Exclusion Criteria:

- Autonomous system neuropathy

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Other:
• Algorithm for insulin administration

Locations
Country Name City State
Spain Endocrinology and Nutrition Department. Corporació Sanitària i Universitària Parc Taulí Sabadell Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time spent with glucose in the target range Yes
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