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
About this trial
This is an interventional treatment trial for Type 1 Diabetes
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
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
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
Learn more about this trial
Nocturnal Insulin-Glucose in Hospital: Tight Control
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