Rule-Based Closed Loop System for Type 1 Diabetes Control
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Algorithm for insulin administration
Sponsored by
About this trial
This is an interventional trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 1 Diabetes
- Insulin pump treatment
- Undetectable C-Peptide
Exclusion Criteria:
- Autonomous system neuropathy
Sites / Locations
- Endocrinology and Nutrition Department. Corporació Sanitària i Universitària Parc Taulí
Outcomes
Primary Outcome Measures
Time spent with glucose in the target range
Secondary Outcome Measures
Full Information
NCT ID
NCT01614496
First Posted
June 7, 2012
Last Updated
September 23, 2013
Sponsor
Corporacion Parc Tauli
1. Study Identification
Unique Protocol Identification Number
NCT01614496
Brief Title
Rule-Based Closed Loop System for Type 1 Diabetes Control
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Algorithm for insulin administration
Primary Outcome Measure Information:
Title
Time spent with glucose in the target range
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
Type 1 Diabetes
Insulin pump treatment
Undetectable C-Peptide
Exclusion Criteria:
Autonomous system neuropathy
Facility Information:
Facility Name
Endocrinology and Nutrition Department. Corporació Sanitària i Universitària Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24152323
Citation
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.
Results Reference
derived
Learn more about this trial
Rule-Based Closed Loop System for Type 1 Diabetes Control
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