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Trial record 49 of 750 for:    Area Under Curve AND meal

Closed-loop Control of Postprandial Glucose Levels After Meals With Different Macronutrients Content in Adults With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02774876
Recruitment Status : Completed
First Posted : May 17, 2016
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Institut de Recherches Cliniques de Montreal

Brief Summary:
Carbohydrates are the main determinant of post-meal glucose excursion. However, fat and protein have been shown to also impact the postprandial glucose control, adding to the complexity of meal insulin calculation. Few studies have looked at the effect of macronutrients other than carbohydrates on postprandial glucose excursions with the closed-loop strategy. The objective of this study is to test whether the single-hormone closed-loop strategy can achieve similar post-meal glucose control with meals with a fixed carbohydrate content, but high in protein and/or fat when compared to a meal with a fixed carbohydrate content only.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Patient's insulin pump Drug: Insulin Device: Dexcom G4 Platinum glucose sensor Other: Single-hormone closed-loop Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Four-way, Cross-over Study to Examine the Efficacy of Single-hormone Closed-loop System in Regulating Glucose Levels in Adults With Type 1 Diabetes Following Meals of Various Macronutrient Contents: a Pilot Study
Study Start Date : June 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Carbohydrate meal Device: Patient's insulin pump
The patient's insulin pump will be used to regulate glucose levels.

Drug: Insulin
Patient's usual fast-acting insulin analog will be used.

Device: Dexcom G4 Platinum glucose sensor
The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.

Other: Single-hormone closed-loop
Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at IRCM at 6:30 am in a fasting state. At 7:00, single-hormone closed-loop will be initiated. At 8:00, if glucose levels are between 3.5 and 12.5 mmol/L, the meal will be served. Patients will have 20 minutes to consume the meal. If glucose levels are not in this target range, the meal will be delayed for a maximum of 45 minutes. If after 45 minutes, glucoses levels are still not between 3.5 and 12.5 mmol/L, the test will be cancelled and rescheduled. The test meals will be: 1) 75g of CHO; 2) 75g of CHO + 35g of protein; 3) 75g of CHO + 35g of fat; or 4) 75g of CHO + 35g of protein + 35g of fat. The intervention day will end at 13:00.

Active Comparator: Carbohydrate + fat meal Device: Patient's insulin pump
The patient's insulin pump will be used to regulate glucose levels.

Drug: Insulin
Patient's usual fast-acting insulin analog will be used.

Device: Dexcom G4 Platinum glucose sensor
The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.

Other: Single-hormone closed-loop
Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at IRCM at 6:30 am in a fasting state. At 7:00, single-hormone closed-loop will be initiated. At 8:00, if glucose levels are between 3.5 and 12.5 mmol/L, the meal will be served. Patients will have 20 minutes to consume the meal. If glucose levels are not in this target range, the meal will be delayed for a maximum of 45 minutes. If after 45 minutes, glucoses levels are still not between 3.5 and 12.5 mmol/L, the test will be cancelled and rescheduled. The test meals will be: 1) 75g of CHO; 2) 75g of CHO + 35g of protein; 3) 75g of CHO + 35g of fat; or 4) 75g of CHO + 35g of protein + 35g of fat. The intervention day will end at 13:00.

Active Comparator: Carbohydrate + protein meal Device: Patient's insulin pump
The patient's insulin pump will be used to regulate glucose levels.

Drug: Insulin
Patient's usual fast-acting insulin analog will be used.

Device: Dexcom G4 Platinum glucose sensor
The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.

Other: Single-hormone closed-loop
Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at IRCM at 6:30 am in a fasting state. At 7:00, single-hormone closed-loop will be initiated. At 8:00, if glucose levels are between 3.5 and 12.5 mmol/L, the meal will be served. Patients will have 20 minutes to consume the meal. If glucose levels are not in this target range, the meal will be delayed for a maximum of 45 minutes. If after 45 minutes, glucoses levels are still not between 3.5 and 12.5 mmol/L, the test will be cancelled and rescheduled. The test meals will be: 1) 75g of CHO; 2) 75g of CHO + 35g of protein; 3) 75g of CHO + 35g of fat; or 4) 75g of CHO + 35g of protein + 35g of fat. The intervention day will end at 13:00.

Active Comparator: Carbohydrate + fat + protein meal Device: Patient's insulin pump
The patient's insulin pump will be used to regulate glucose levels.

Drug: Insulin
Patient's usual fast-acting insulin analog will be used.

Device: Dexcom G4 Platinum glucose sensor
The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.

Other: Single-hormone closed-loop
Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at IRCM at 6:30 am in a fasting state. At 7:00, single-hormone closed-loop will be initiated. At 8:00, if glucose levels are between 3.5 and 12.5 mmol/L, the meal will be served. Patients will have 20 minutes to consume the meal. If glucose levels are not in this target range, the meal will be delayed for a maximum of 45 minutes. If after 45 minutes, glucoses levels are still not between 3.5 and 12.5 mmol/L, the test will be cancelled and rescheduled. The test meals will be: 1) 75g of CHO; 2) 75g of CHO + 35g of protein; 3) 75g of CHO + 35g of fat; or 4) 75g of CHO + 35g of protein + 35g of fat. The intervention day will end at 13:00.




Primary Outcome Measures :
  1. Area under the curve of sensor glucose levels [ Time Frame: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00. ]

Secondary Outcome Measures :
  1. Mean sensor glucose levels [ Time Frame: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00. ]
  2. Peak glucose excursion [ Time Frame: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00. ]
  3. Time to peak glucose [ Time Frame: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00. ]
  4. Percentage of time of sensor glucose concentrations between 3.9 and 7.8 mmol/L [ Time Frame: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00. ]
  5. Percentage of time of sensor glucose concentrations between 3.9 and 10 mmol/L [ Time Frame: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00. ]
  6. Percentage of time of sensor glucose concentrations above 10 mmol/L [ Time Frame: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00. ]
  7. Percentage of time of sensor glucose concentrations above 13.9 mmol/L [ Time Frame: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00. ]
  8. Total insulin delivery [ Time Frame: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00. ]
  9. Standard deviation of glucose levels [ Time Frame: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00. ]
  10. Coefficient of variation of glucose levels [ Time Frame: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00. ]


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 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 and currently using fast-acting insulin analog (Lispro, Aspart or Guilisine).
  4. Last (less than 3 months) HbA1c ≤ 10%.

Exclusion Criteria:

  1. 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.
  2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  3. Ongoing pregnancy.
  4. Severe hypoglycemic episode within 1 month of screening.
  5. Agents affecting gastric emptying (Motilium®, Prandase®, all GLP-1 analogs) 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.
  6. 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®). Inhaled steroids at stable dose in the last month are acceptable.
  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 (e.g. unstable psychiatric condition).
  8. Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, 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): NCT02774876


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

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Responsible Party: Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT02774876     History of Changes
Other Study ID Numbers: CLASS-Macro
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut de Recherches Cliniques de Montreal:
Closed-loop system
Artificial pancreas
Glucose control
Meal
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hormones
Nutrients
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Growth Substances