Rule-Based Closed Loop System for Type 1 Diabetes Control
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedSeptember 24, 2013
June 1, 2013
June 7, 2012
September 23, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Time spent with glucose in the target range
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 Diabetes
- Insulin pump treatment
- Undetectable C-Peptide
You may not qualify if:
- Autonomous system neuropathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Endocrinology and Nutrition Department. Corporació Sanitària i Universitària Parc Taulí
Sabadell, Barcelona, 08208, Spain
Related Publications (1)
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.
PMID: 24152323DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 8, 2012
Last Updated
September 24, 2013
Record last verified: 2013-06