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Completed

NCT Number: NCT01444443

DiaCon Overnight Closed-Loop Glucose Control Study

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed-loop control

Device

Blood glucose controlled by algorithm

Other names: Metronic Veo-pump. DexCom 7+ sensor.

Open-loop control

Other

Blood glucose controlled by patient

Primary outcomes

  1. Number of hypoglycemic events

    Time frame: 22:00-07:00

Secondary outcomes

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

    Time frame: 22:00-07:00

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Novo Nordisk A/S
  • Technical University of Denmark

Registry information

Official study title

DiaCon Closed-Loop Study

Acronym: DiaCon2

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 30, 2011
Registry last updated
Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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