Rule-Based Closed Loop System for Type 1 Diabetes Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Interventions

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Algorithm for insulin administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Autonomous system neuropathy

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Endocrinology and Nutrition Department. Corporació Sanitària i Universitària Parc Taulí

Sabadell, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED

PMID: 24152323 (View on PubMed)

Other Identifiers

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PS09/01255

Identifier Type: -

Identifier Source: org_study_id