Nocturnal Insulin-Glucose in Hospital: Tight Control (NIGHT CONTROL)

June 9, 2014 updated by: Mercedes Rigla, Corporacion Parc Tauli
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mercedes Rigla, MD, PhD
  • Phone Number: +34 93 745 84 12
  • Email: mrigla@tauli.cat

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Parc Tauli University Hospital
        • Contact:
          • Mercedes Rigla, MD, PhD
          • Phone Number: +34 93 745 84 12
          • Email: mrigla@tauli.cat
        • Principal Investigator:
          • Mercedes Rigla, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time in target range (3.9-8.0 mmol/l) YSI glucose during the in clinic overnight visit.
Time Frame: During the closed-loop period for each patient: 12 hours
During the closed-loop period for each patient: 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Mercedes Rigla, MD, PhD, Parc Tauli University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 9, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIGHT CONTROL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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