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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014