DiaCon Overnight Closed-Loop Glucose Control Study (DiaCon2)

This study has been completed.
Sponsor:
Collaborators:
Technical University of Denmark
Novo Nordisk A/S
Information provided by (Responsible Party):
Signe Schmidt, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01444443
First received: September 28, 2011
Last updated: November 19, 2012
Last verified: November 2012
  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: Open Label
Primary Purpose: Treatment
Official Title: DiaCon Closed-Loop Study

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Number of hypoglycemic events [ Time Frame: 22:00-07:00 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time spent in euglycemia (3.9-8.0 mmol/l); mean blood glucose level; LBGI [ Time Frame: 22:00-07:00 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 28, 2011
Last Updated: November 19, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: The Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on April 17, 2014