Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7, Canada
NCT Number: NCT02774876
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Montreal, Quebec, H2W 1R7, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient's insulin pump will be used to regulate glucose levels.
Patient's usual fast-acting insulin analog will be used.
The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Institut de Recherches Cliniques de Montreal
Other
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
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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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