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

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ClinicalTrials.gov Identifier: NCT02160184
Recruitment Status : Unknown
Verified June 2014 by Mercedes Rigla, Corporacion Parc Tauli.
Recruitment status was:  Not yet recruiting
First Posted : June 10, 2014
Last Update Posted : June 10, 2014
Sponsor:
Information provided by (Responsible Party):
Mercedes Rigla, Corporacion Parc Tauli

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Estimated Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160184


Contacts
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Contact: Mercedes Rigla, MD, PhD +34 93 745 84 12 mrigla@tauli.cat

Locations
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Spain
Parc Tauli University Hospital
Sabadell, Barcelona, Spain, 08208
Contact: Mercedes Rigla, MD, PhD    +34 93 745 84 12    mrigla@tauli.cat   
Principal Investigator: Mercedes Rigla, MD, PhD         
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Mercedes Rigla, MD, PhD Parc Tauli University Hospital
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Responsible Party: Mercedes Rigla, MD, PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02160184    
Other Study ID Numbers: NIGHT CONTROL
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancrelipase
Gastrointestinal Agents