DiaCon Overnight Closed-Loop Glucose Control Study (DiaCon2)
This study has been completed.
Sponsor:
Hvidovre University Hospital
Collaborators:
Technical University of Denmark
Novo Nordisk
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Dextrose
U.S. FDA Resources
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
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 May 19, 2013