Nocturnal Insulin-Glucose in Hospital: Tight Control

The aim of the study is to assess the efficacy and safety of a closed-loop system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and post-breakfast periods. Intervention will be to apply the automated closed-loop system by administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a continuous glucose measurement (CGM) system.

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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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parc Tauli University Hospital

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Type 1 Diabetes
Diabetes duration > 3 years
Continuous Subcutaneous Insulin Infusion (CSII) treatment for more than 1 year
A1c 6-9%
No ketoacidosis during the previous 12 months
Glomerular Filtration Rate (GFR) > 60 ml/kg/min m2
Willingness of participate and signed and dated written informed consent in accordance with Good Clinical Practice

Exclusion criteria

Gastroparesis
Hypoglycemia unawareness
Uncorrected visual impairment
Deafness
BMI> 35 kg/m2

Treatment and study plan

Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)

Device

Primary outcomes

Percentage of time in target range (3.9-8.0 mmol/l) YSI glucose during the in clinic overnight visit.

Time frame: During the closed-loop period for each patient: 12 hours

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Acronym: NIGHT CONTROL

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jun 10, 2014
Registry last updated: Aug 22, 2024

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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Completed