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Completed

NCT Number: NCT02416765

Closed-loop Control of Postprandial Glucose Levels in Adults With Type 1 Diabetes

Postprandial meal glucose control with closed-loop systems (CLS) still needs some improvements. In the postprandial period, sensor delay in detecting blood glucose rise after a meal together with delays in insulin absorption expose patients to early risk of hyperglycemia and then to late-postprandial hypoglycemia. Glucagon infusion in dual-hormone CLS has the potential to improve post-meal control as compared to single-hormone CLS allowing a better glucose excursion related to a more aggressive insulin infusion while minimizing hypoglycemic risk. Several approaches have been tested for the determination of prandial boluses during closed-loop operation.

The objective of this study is to test in outpatient unrestricted settings whether, in the context of closed-loop strategy, conventional meal carbohydrate counting could be reduced to a simplified qualitative meal size estimation without a significant degradation in overall glycemic control in adult patients with type 1 diabetes.

The investigators hypothesize that in outpatient free-living conditions: 1) Dual-hormone CLS with partial boluses is equivalent to dual-hormone CLS with full boluses in terms of mean glucose; 2) Single-hormone CLS with partial boluses is equivalent to single-hormone CLS with full boluses in terms of mean glucose. Secondary hypothesis are: 3) Dual-hormone CLS with partial boluses will decrease time in hypoglycemia compared to single-hormone CLS with partial boluses; 4) Dual-hormone CLS with partial boluses is better than sensor-augmented pump therapy in terms of mean glucose; 5) Single-hormone CLS with partial boluses is better than sensor-augmented pump therapy in terms of mean glucose.

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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, H2W1R7, 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 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 and currently using a fast actin insulin analog (Lispro, Aspart or Guilisine).
  • Last (less than 3 months) HbA1c ≤ 10%.
  • Currently using carbohydrate counting as the meal insulin dose strategy.

Exclusion criteria

  • Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
  • Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Ongoing pregnancy.
  • Severe hypoglycemic episode within 1 month of screening.
  • Agents affecting gastric emptying (Motilium®, Prandase®, Victoza®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, SGLT-2 inhibitors and DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
  • Oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone Cortef®). Inhale steroids at stable dose in the last month are acceptable.
  • 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. unstable psychiatric condition).
  • Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).
  • Living or planned travel outside Montreal (> 1h of driving) area during closed-loop procedures.

Treatment and study plan

15-hour intervention

Other

Interventions will be conducted in outpatient settings. Subject's usual insulin will be used. Meals will not be standardized. Subjects will be allowed to eat whatever and when they want and will be allowed to drink alcohol. Subjects will be allowed to exercise, but they will be asked to do the same amount and intensity of exercise on all intervention visits. Subjects will be accompanied all the time by a member from the research team during closed-loop visits to implement hormonal infusions.

Insulin (Lispro, Aspart or guilisine)

Drug

Patient's usual insulin (Lispro, Aspart or guilisine) will be used in all interventions.

Glucagon (Eli Lilly)

Drug

In the dual-hormone CLS interventions, glucagon (Eli Lilly) will be used.

Closed-loop strategy

Other

Every 10 minutes, the glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom) will be entered manually into the computer. The pumps' infusion rate will then be changed manually based on the computer generated recommendation infusion rates. The computer generated recommendations are based on a predictive algorithm.

Primary outcomes

  1. Mean glucose levels as measured by the glucose sensor.

    Time frame: 15 hours

    The following comparisons will be done: 1) Dual-hormone CLS with partial boluses vs. dual-hormone CLS with full boluses; 2) Single-hormone CLS with partial boluses vs. single-hormone CLS with full boluses.

Secondary outcomes

  1. Mean glucose levels as measured by the glucose sensor

    Time frame: 15 hours

    The following comparisons will be done: 1) Dual-hormone CLS with partial boluses vs. single-hormone CLS with partial boluses; 2) Dual-hormone CLS with partial boluses vs. sensor-augmented pump therapy; 3) Single-hormone CLS with partial boluses vs. sensor-augmented pump therapy.

  2. Percentage of time of sensor glucose concentrations between 4 and 8 mmol/L

    Time frame: 15 hours

  3. Percentage of time of sensor glucose concentrations between 4 and 10 mmol/L

    Time frame: 15 hours

  4. Percentage of time of sensor glucose concentrations above 10 mmol/L

    Time frame: 15 hours

  5. Percentage of time of sensor glucose concentrations above 14 mmol/L

    Time frame: 15 hours

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

    Time frame: 15 hours

  7. Percentage of time of glucose levels spent below 3.1 mmol/L

    Time frame: 15 hours

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

    Time frame: 15 hours

  9. Area under the curve of glucose values below 3.1 mmol/L

    Time frame: 15 hours

  10. Number of patients with at least one hypoglycemic event below 3.1 mmol/L with or without symptoms

    Time frame: 15 hours

  11. Total number of hypoglycemic event below 3.1 mmol/L

    Time frame: 15 hours

  12. Total insulin delivery

    Time frame: 15 hours

  13. Total glucagon delivery

    Time frame: 15 hours

  14. Standard deviation of glucose levels

    Time frame: 15 hours

  15. Total carbohydrate intake

    Time frame: 15 hours

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Official study title

An Open-label, Randomized, Five-way, Cross-over Study to Compare the Efficacy of Single- and Dual-hormone Closed-loop Operations Combined With Either Conventional Carbohydrate Counting or a Simplified Qualitative Meal-size Estimation, and Sensor-augmented Pump Therapy in Regulating Glucose Levels in Adults With Type 1 Diabetes

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 15, 2015
Registry last updated
Nov 16, 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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