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DiaCon Overnight Closed-Loop Glucose Control Study (DiaCon2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444443
First Posted: September 30, 2011
Last Update Posted: November 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Technical University of Denmark
Novo Nordisk A/S
Information provided by (Responsible Party):
Signe Schmidt, Hvidovre University Hospital
  Purpose
The objective of this in-clinic study is to test our closed-loop glucose control system in patients with type 1 diabetes.

Condition Intervention
Type 1 Diabetes Device: Closed-loop control Other: Open-loop control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DiaCon Closed-Loop Study

Resource links provided by NLM:


Further study details as provided by Signe Schmidt, Hvidovre University Hospital:

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

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

Enrollment: 12
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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 Submitted: September 28, 2011
First Posted: September 30, 2011
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