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

NCT02774876 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-10-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Institut de Recherches Cliniques de Montreal

    lead OTHER

Principal Investigators

  • Remi Rabasa-Lhoret · Institut de recherches cliniques de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02774876 on ClinicalTrials.gov