DiaCon Overnight Closed-Loop Glucose Control Study

NCT ID: NCT01444443

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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Conditions

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Type 1 Diabetes

Keywords

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Type 1 diabetes Glucose control Closed-loop Insulin pump Glucose sensor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closed-loop glucose control

Blood glucose controlled by control algorithm.

Group Type EXPERIMENTAL

Closed-loop control

Intervention Type DEVICE

Blood glucose controlled by algorithm

Open-loop glucose control

Blood glucose controlled by patient

Group Type ACTIVE_COMPARATOR

Open-loop control

Intervention Type OTHER

Blood glucose controlled by patient

Interventions

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Closed-loop control

Blood glucose controlled by algorithm

Intervention Type DEVICE

Open-loop control

Blood glucose controlled by patient

Intervention Type OTHER

Other Intervention Names

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Metronic Veo-pump. DexCom 7+ sensor.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Denmark

OTHER

Sponsor Role collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Signe Schmidt

MD, Clinical research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Signe Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2106-07-0034

Identifier Type: -

Identifier Source: org_study_id