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Completed

NCT Number: NCT02189694

Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp.

The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

About this study

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

The investigators aim to conduct a randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. The investigators aim to compare the three interventions for 3 consecutive nights in children with type 1 diabetes in a diabetes camp.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or females between the 8 and 17 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year. The subject will have been on insulin pump therapy for at least 3 months.
  • HbA1c ≤ 11.0%.

Exclusion criteria

  • Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  • Severe hypoglycemic episode within two weeks of inclusion in the study. A severe hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency visit.
  • Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable.
  • Known or suspected allergy to the trial products.
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  • Failure to comply with team's recommendations (e.g. not willing to use trial pump, etc).

Treatment and study plan

Single-hormone closed-loop strategy

Device

Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.

Dual-hormone closed-loop strategy

Device

Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) and Glucagon (Eli Lilly and Company) will be used.

Insulin pump therapy

Device

Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.

Primary outcomes

  1. Percentage of time of glucose levels spent below 4.0 mmol/L.

    Time frame: Up to 8 hours

Secondary outcomes

  1. Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L

    Time frame: Up to 8 hours

  2. Percentage of time of glucose levels spent below 3.5 mmol/L

    Time frame: Up to 8 hours

  3. Percentage of time of glucose levels spent below 3.3 mmol/L

    Time frame: Up to 8 hours

  4. Percentage of time of glucose levels spent above 8 mmol/L

    Time frame: Up to 8 hours

  5. Percentage of time of glucose levels spent above 10 mmol/L.

    Time frame: Up to 8 hours

  6. Area under the curve of glucose levels below 4.0 mmol/L

    Time frame: Up to 8 hours

  7. Area under the curve of glucose levels below 3.5 mmol/L

    Time frame: Up to 8 hours

  8. Area under the curve of glucose levels below 3.3 mmol/L

    Time frame: Up to 8 hours

  9. Area under the curve of glucose levels above 8.0 mmol/L

    Time frame: Up to 8 hours

  10. Area under the curve of glucose levels above 10.0 mmol/L.

    Time frame: Up to 8 hours

  11. Mean glucose levels.

    Time frame: Up to 8 hours

  12. Standard deviation of glucose levels

    Time frame: Up to 8 hours

    Measure of glucose variability.

  13. Total insulin delivery

    Time frame: Up to 8 hours

  14. Hypoglycemic risk assessed by the total number of hypoglycemic event (> 15 minutes) below 3.1 mmol/L

    Time frame: Up to 8 hours

  15. Hypoglycemic risk assessed by the number of patients experiencing at least one hypoglycemic event (> 15 minutes) below 3.1 mmol/L

    Time frame: Up to 8 hours

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Collaborators

  • Montreal Children's Hospital of the MUHC

Registry information

Official study title

An Open-label, Randomized, Three-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Pump Therapy in Regulating Overnight Glucose Levels in Children With Type 1 Diabetes in a Diabetes Camp

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2014
Registry last updated
Sep 3, 2014

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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