DiaCon Overnight Closed-Loop Glucose Control Study | NCT01444443

Studies
DiaCon Overnight Closed-Loop Glucose Control Study

NCT01444443

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Nov 20, 2012Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes

Interventions

Closed-loop control
Open-loop control

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Sep 28, 2011

First Submission Date that Met QC Criteria

Sep 29, 2011

First Posted Date

Sep 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2012

Last Update Posted Date

Nov 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Signe Schmidt, MD, Clinical research fellow, Hvidovre University HospitalPrincipal Investigator

Lead Sponsor

Hvidovre University HospitalOTHER

Collaborators

Name	Class
Technical University of Denmark	OTHER
Novo Nordisk A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Closed-loop glucose control	Experimental	Blood glucose controlled by control algorithm.	Device: Closed-loop control
Open-loop glucose control	Active Comparator	Blood glucose controlled by patient	Other: Open-loop control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Closed-loop control	Device	Blood glucose controlled by algorithm	Closed-loop glucose control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of hypoglycemic events		22:00-07:00

Secondary Outcomes

Measure	Description	Time Frame
Time spent in euglycemia (3.9-8.0 mmol/l); mean blood glucose level; LBGI		22:00-07:00

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Signe Schmidt, MD	Hvidovre University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital		Hvidovre		2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided