NCT01444443

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

7 months

First QC Date

September 28, 2011

Last Update Submit

November 19, 2012

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesGlucose controlClosed-loopInsulin pumpGlucose sensor

Outcome Measures

Primary Outcomes (1)

  • Number of hypoglycemic events

    22:00-07:00

Secondary Outcomes (1)

  • Time spent in euglycemia (3.9-8.0 mmol/l); mean blood glucose level; LBGI

    22:00-07:00

Study Arms (2)

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

Closed-loop controlDEVICE

Blood glucose controlled by algorithm

Also known as: Metronic Veo-pump. DexCom 7+ sensor.
Closed-loop glucose control
Open-loop controlOTHER

Blood glucose controlled by patient

Open-loop glucose control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • Type 1 diabetes duration \> 2 years
  • HbA1c \< 8%
  • Insulin pump user \> 1 year

You may not qualify if:

  • Use of medication affecting glucose metabolism
  • Pregnancy or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Signe Schmidt, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Clinical research fellow

Study Record Dates

First Submitted

September 28, 2011

First Posted

September 30, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations

DK(1)