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Completed

NCT Number: NCT02282254

Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Type 1 Diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia

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 strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The main objective of this project is to compare the efficacy of single-hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels in a in-patient study in type 1 diabetes adults with hypoglycemia unawareness and documented nocturnal hypoglycemia.

The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels compared to single-hormone closed-loop strategy.

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Key information

Conditions

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

Age range

18 year and older

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 strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The investigators aim to conduct the 1st randomized cross-over trial comparing single- hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels. The investigators aim to compare the two interventions for 10 hours in two subgroups of adults with type 1 diabètes. Patients from both subgroups will present documented nocturnal hypoglycemia. One subgroup will consist of patients with hypoglycemia unawareness while the other subgroup will consist of patients with hypoglycemia unawareness. This study will allow to determine if there is a greater benefit of a closed-loop strategy in a higher-risk hypoglycemia unaware group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females ≥ 18 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 ≤ 12%.
  • Hypoglycemia awareness or unawareness assessed by a questionnaire.
  • Documented NH during the run-in period.

Exclusion criteria

  • Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  • Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Current use of glucocorticoid medication (except low stable dose).
  • Known or suspected allergy to the trial products or snack contents.
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  • Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
  • Failure to comply with team's recommendations (e.g. not willing to eat snacks, not willing to change pump parameters, etc).

Treatment and study plan

Overnight intervention

Other

Subjects will be admitted at the research facility at 19:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. On dual-hormone closed-loop visits, glucagon will be reconstituted according to the manufacturer's instructions and a MiniMed® Paradigm® Veo™ pump containing the glucagon solution will be installed. At 20:30, a snack containing 20g of carbohydrate will be given. Closed-loop strategy will start at 20:00 until 7:00 next morning. A glucose sensor reading will be entered manually in a tablet every 10 minutes. The tablet will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses (glucagon recommendations will only be generated during the dual hormone closed-loop visits). Pumps' parameters will then be changed manually to implement the tablet generated recommendations.

Primary outcomes

  1. Percentage of time of plasma glucose levels spent below 4 mmol/L

    Time frame: Up to 8 hours

Secondary outcomes

  1. Percentage of time of plasma glucose levels spent between 4 and 8 mmol/L

    Time frame: Up to 8 hours

  2. Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L

    Time frame: Up to 8 hours

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

    Time frame: Up to 8 hours

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

    Time frame: Up to 8 hours

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

    Time frame: Up to 8 hours

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

    Time frame: Up to 8 hours

  7. Area under the curve of plasma glucose levels spent below 4 mmol/L

    Time frame: Up to 8 hours

  8. Area under the curve of plasma glucose levels spent below 3.5 mmol/L

    Time frame: Up to 8 hours

  9. Area under the curve of plasma glucose levels spent below 3.3 mmol/L

    Time frame: Up to 8 hours

  10. Area under the curve of plasma glucose levels spent above 8 mmol/L

    Time frame: Up to 8 hours

  11. Area under the curve of plasma glucose levels spent above 10 mmol/L

    Time frame: Up to 8 hours

  12. Mean plasma glucose levels

    Time frame: Up to 8 hours

  13. Standard deviation of plasma glucose levels

    Time frame: Up to 8 hours

  14. Total insulin delivery

    Time frame: Up to 8 hours

  15. Total glucagon delivery

    Time frame: Up to 8 hours

  16. Number of subjects experiencing at least one hypoglycemic event requiring oral treatment

    Time frame: Up to 8 hours

  17. Total number of hypoglycemic events requiring treatment

    Time frame: Up to 8 hours

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Official study title

An Open-label, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone and Dual-hormone Closed-loop Strategy in Regulating Overnight Glucose Levels in Type 1 diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 4, 2014
Registry last updated
Nov 10, 2016

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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