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

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ClinicalTrials.gov Identifier: NCT02282254
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Overnight intervention Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Single-hormone closed-loop strategy Other: Overnight intervention
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.

Active Comparator: Dual-hormone closed-loop strategy Other: Overnight intervention
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 Outcome Measures :
  1. Percentage of time of plasma glucose levels spent below 4 mmol/L [ Time Frame: Up to 8 hours ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females ≥ 18 years of old.
  2. Clinical diagnosis of type 1 diabetes for at least one year.
  3. The subject will have been on insulin pump therapy for at least 3 months.
  4. HbA1c ≤ 12%.
  5. Hypoglycemia awareness or unawareness assessed by a questionnaire.
  6. Documented NH during the run-in period.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282254


Locations
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Canada, Quebec
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Investigators
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Principal Investigator: Remi Rabasa-Lhoret Institut de recherches cliniques de Montréal

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rémi Rabasa-Lhoret, Associate Professor of Medicine, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT02282254     History of Changes
Other Study ID Numbers: CLASS-09
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016

Keywords provided by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal:
Type 1 diabetes
Hypoglycemia unawareness
Nocturnal hypoglycemia
Closed-loop strategy
Artificial pancreas
Glucagon
Hypoglycemia
Insulin

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Unconsciousness
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hormones
Glucagon
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents