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Completed

NCT Number: NCT01966393

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 60 Hours in Adults With Type 1 Diabetes

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 closed-loop strategy, dual-hormone closed-loop strategy and conventional insulin pump therapy to regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes.

The investigators hypothesized that 1) Controlling glucose levels using single- or dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2) Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional pump therapy.

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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

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%.

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.
  • History of pheochromocytoma or insulinoma (glucagon could induce an hormonal response of these tumors)
  • Beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses)
  • Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose)
  • Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
  • Anticholinergic drug (risk of interaction)
  • Pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
  • Known or suspected allergy to the trial products or meal contents (gluten free menus will be available).
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. need for major revision of carbohydrate counting).
  • 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 meals/snacks, not willing to change pump parameters, etc).
  • Treatments that could interfere with glucagon

Treatment and study plan

60-hours intervention

Other

Interventions will be conducted at the research centre (RC) or at the patient's home based on the patient's preference. If the study takes place at the RC, patients will be admitted at 7:00. If the study takes place at the patient's home, a research team member will be at the patient's home at 7:00. Closed-loop strategy will start at 8:00 on day 1 and end at 20:00 on day 3. During the interventions conducted at the RC, patients will have access to entertainment activities such as movies, video games, board games, foosball, etc. During the interventions conducted at the patient's home, patients will do their usual activities. For interventions conducted at the RC, patients will freely choose their meals from a large choice of prepared frozen meals. For interventions conducted at the patient's home, patients will freely choose their meals. Participants will be encouraged to conduct their usual physical activities whether they conduct the study at the RC or at the patient's home.

Primary outcomes

  1. Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in the hypoglycemic range.

    Time frame: 60 hours

    Hypoglycemic range is defined to be between below 4 mmol/L

Secondary outcomes

  1. Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in target range.

    Time frame: 60 hours

    Target range is defined to be between 4 and 10 mmol/L from 7:00 to 22:00 and between 4 and 8 mmol/L from 22:00 to 7:00.

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

    Time frame: 60 hours

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

    Time frame: 60 hours

  4. Area under the curve of glucose values below 4.0 mmol/L

    Time frame: 60 hours

  5. Area under the curve of glucose values below 3.5 mmol/L

    Time frame: 60 hours

  6. Area under the curve of glucose values below 3.3 mmol/L

    Time frame: 60 hours

  7. Percentage of time of glucose levels spent above 8.0 mmol/L

    Time frame: 60 hours

  8. Percentage of time of glucose levels spent above 10.0 mmol/L

    Time frame: 60 hours

  9. Mean value of glucose levels

    Time frame: 60 hours

  10. Standard deviation of glucose levels

    Time frame: 60 hours

  11. Total insulin delivery

    Time frame: 60 hours

  12. Number of patients with at least one hypoglycemic event with or without symptoms below 3.0 mmol/L based on glucose sensor reading

    Time frame: 60 hours

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

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 Insulin Pump Therapy in Regulating Glucose Levels During 60 Hours in Free-living Conditions in Patients With Type 1 Diabetes

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2013
Registry last updated
May 4, 2015

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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