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

NCT02774876 | Completed Phase 2

• 1 other identifier: CLASS-Macro
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Closed-loop system; Artificial pancreas; Glucose control; Meal

Outcome Measures

Primary Outcomes (1)

• Area under the curve of sensor glucose levels

  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 Outcomes (10)

• Mean sensor glucose levels

  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.

• Peak glucose excursion

  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.

• Time to peak glucose

  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.

• Percentage of time of sensor glucose concentrations between 3.9 and 7.8 mmol/L

  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.

• Percentage of time of sensor glucose concentrations between 3.9 and 10 mmol/L

  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.

Study Arms (4)

Carbohydrate meal

ACTIVE COMPARATOR

Device: Patient's insulin pump; Drug: Insulin; Device: Dexcom G4 Platinum glucose sensor; Other: Single-hormone closed-loop

Carbohydrate + fat meal

ACTIVE COMPARATOR

Device: Patient's insulin pump; Drug: Insulin; Device: Dexcom G4 Platinum glucose sensor; Other: Single-hormone closed-loop

Carbohydrate + protein meal

ACTIVE COMPARATOR

Device: Patient's insulin pump; Drug: Insulin; Device: Dexcom G4 Platinum glucose sensor; Other: Single-hormone closed-loop

Carbohydrate + fat + protein meal

ACTIVE COMPARATOR

Device: Patient's insulin pump; Drug: Insulin; Device: Dexcom G4 Platinum glucose sensor; Other: Single-hormone closed-loop

Interventions

Patient's insulin pump DEVICE

The patient's insulin pump will be used to regulate glucose levels.

Carbohydrate + fat + protein meal; Carbohydrate + fat meal; Carbohydrate + protein meal; Carbohydrate meal

Insulin DRUG

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

Carbohydrate + fat + protein meal; Carbohydrate + fat meal; Carbohydrate + protein meal; Carbohydrate meal

Dexcom G4 Platinum glucose sensor DEVICE

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

Carbohydrate + fat + protein meal; Carbohydrate + fat meal; Carbohydrate + protein meal; Carbohydrate meal

Single-hormone closed-loop OTHER

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.

Carbohydrate + fat + protein meal; Carbohydrate + fat meal; Carbohydrate + protein meal; Carbohydrate meal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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®, 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.
• 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.
• 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).

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Remi Rabasa-Lhoret

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 17, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 30, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)