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DiaCon Overnight Closed-Loop Glucose Control Study (DiaCon2)

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ClinicalTrials.gov Identifier: NCT01444443
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : November 20, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this in-clinic study is to test our closed-loop glucose control system in patients with type 1 diabetes.

Condition or disease Intervention/treatment
Type 1 Diabetes Device: Closed-loop control Other: Open-loop control

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DiaCon Closed-Loop Study
Study Start Date : November 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Dextrose
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Closed-loop glucose control
Blood glucose controlled by control algorithm.
Device: Closed-loop control
Blood glucose controlled by algorithm
Other Name: Metronic Veo-pump. DexCom 7+ sensor.
Active Comparator: Open-loop glucose control
Blood glucose controlled by patient
Other: Open-loop control
Blood glucose controlled by patient


Outcome Measures

Primary Outcome Measures :
  1. Number of hypoglycemic events [ Time Frame: 22:00-07:00 ]

Secondary Outcome Measures :
  1. Time spent in euglycemia (3.9-8.0 mmol/l); mean blood glucose level; LBGI [ Time Frame: 22:00-07:00 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 years
  • Type 1 diabetes duration > 2 years
  • HbA1c < 8%
  • Insulin pump user > 1 year

Exclusion Criteria:

  • Use of medication affecting glucose metabolism
  • Pregnancy or nursing
Contacts and Locations

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): NCT01444443


Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Technical University of Denmark
Novo Nordisk A/S
Investigators
Principal Investigator: Signe Schmidt, MD Hvidovre University Hospital
More Information

Responsible Party: Signe Schmidt, MD, Clinical research fellow, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01444443     History of Changes
Other Study ID Numbers: 2106-07-0034
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: November 20, 2012
Last Verified: November 2012

Keywords provided by Signe Schmidt, Hvidovre University Hospital:
Type 1 diabetes
Glucose control
Closed-loop
Insulin pump
Glucose sensor

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases