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

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parc Tauli University Hospital

Outcomes

Primary Outcome Measures

Percentage of time in target range (3.9-8.0 mmol/l) YSI glucose during the in clinic overnight visit.

Secondary Outcome Measures

Full Information

First Posted
June 9, 2014
Last Updated
June 9, 2014
Sponsor
Corporacion Parc Tauli
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1. Study Identification

Unique Protocol Identification Number
NCT02160184
Brief Title
Nocturnal Insulin-Glucose in Hospital: Tight Control
Acronym
NIGHT CONTROL
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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 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.

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

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mercedes Rigla, MD, PhD
Phone
+34 93 745 84 12
Email
mrigla@tauli.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercedes Rigla, MD, PhD
Organizational Affiliation
Parc Tauli University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parc Tauli University Hospital
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mercedes Rigla, MD, PhD
Phone
+34 93 745 84 12
Email
mrigla@tauli.cat
First Name & Middle Initial & Last Name & Degree
Mercedes Rigla, MD, PhD

12. IPD Sharing Statement

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Nocturnal Insulin-Glucose in Hospital: Tight Control

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