Nocturnal Insulin-Glucose in Hospital: Tight Control

NCT ID: NCT02160184

Last Updated: 2024-08-22

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

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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The aim of the study is to assess the efficacy and safety of a closed-loop system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and post-breakfast periods. Intervention will be to apply the automated closed-loop system by administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a continuous glucose measurement (CGM) system.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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experimental

Night under closed loop system

Group Type EXPERIMENTAL

Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)

Intervention Type DEVICE

Interventions

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Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Type 1 Diabetes
* Diabetes duration \> 3 years
* Continuous Subcutaneous Insulin Infusion (CSII) treatment for more than 1 year
* A1c 6-9%
* No ketoacidosis during the previous 12 months
* Glomerular Filtration Rate (GFR) \> 60 ml/kg/min m2
* Willingness of participate and signed and dated written informed consent in accordance with Good Clinical Practice

Exclusion Criteria

* Gastroparesis
* Hypoglycemia unawareness
* Uncorrected visual impairment
* Deafness
* BMI\> 35 kg/m2
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Mercedes Rigla

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mercedes Rigla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Parc Tauli University Hospital

Locations

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Parc Tauli University Hospital

Sabadell, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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NIGHT CONTROL

Identifier Type: -

Identifier Source: org_study_id

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