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Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2

25 kwietnia 2017 zaktualizowane przez: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. With this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large). It is however important to establish the safety of this simplified meal bolus approach. The safety of overestimating a meal insulin bolus in the context of closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone closed-loop will be tested.

Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an adequately estimated meal size bolus.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

11

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Kanada
    • Quebec
      • Montreal, Quebec, Kanada, H2W 1R7
        • Institut de recherches cliniques de Montréal

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 a fast acting insulin analog (Lispro, Aspart or Glulisine).
  4. Last (less than 3 months) HbA1c ≤ 10%.
  5. Currently using carbohydrate counting as the meal insulin dose strategy.

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. Pregnancy.
  4. Severe hypoglycemic episode within 1 month of screening.
  5. 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.
  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®). Inhale 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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Dual-hormone CL with overestimation of meal size category
A regular size standardized meal of 45g of carbohydrates will be provided to the patient and the meal size will be overestimated by one category, which will result in a meal insulin bolus for a meal of 65g of carbohydrates.
Lek: Glukagon
Glukagon (Eli Lilly) będzie używany podczas strategii zamkniętej pętli dwóch hormonów.
Urządzenie: Czujnik glukozy Dexcom G4 Platinum
Urządzenie: Pompa insulinowa Accu Chek Combo
Inny: Dual-hormone closed-loop
Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, closed-loop will be initiated. At 9:00, a standardized breakfast (45g CHO) will be served. Study subjects will consume the same meal on the two intervention days. During the intervention, patients will be allowed to do sedentary activities. Patients will be allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions. The intervention day will end at 13:00.
Lek: Insulin
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).
Aktywny komparator: Dual-hormone CL with adequate estimation of meal size category
A regular size standardized meal of 45g of carbohydrates will be provided to the patient and the meal size will be adequately estimated, which will result in a meal insulin bolus for a meal of 35g of carbohydrates.
Lek: Glukagon
Glukagon (Eli Lilly) będzie używany podczas strategii zamkniętej pętli dwóch hormonów.
Urządzenie: Czujnik glukozy Dexcom G4 Platinum
Urządzenie: Pompa insulinowa Accu Chek Combo
Inny: Dual-hormone closed-loop
Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, closed-loop will be initiated. At 9:00, a standardized breakfast (45g CHO) will be served. Study subjects will consume the same meal on the two intervention days. During the intervention, patients will be allowed to do sedentary activities. Patients will be allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions. The intervention day will end at 13:00.
Lek: Insulin
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Percentage of time below 4.0 mmol/L
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
Mean glucose
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations between 4.0 and 8.0 mmol/L
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations between 4.0 and 10.0 mmol/L
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations below 3.1 mmol/L
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Area under the curve of glucose values below 4.0 mmol/L
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Area under the curve of glucose values below 3.1 mmol/L
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Number of patients with at least one hypoglycemic event with or without symptoms
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total number of hypoglycemic event below 3.1 mmol/L
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total carbohydrate intake for hypoglycemia correction
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total insulin delivery
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total glucagon delivery
Ramy czasowe: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Institut de Recherches Cliniques de Montreal

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 czerwca 2016

Zakończenie podstawowe (Rzeczywisty)

1 marca 2017

Ukończenie studiów (Rzeczywisty)

1 marca 2017

Daty rejestracji na studia

Pierwszy przesłany

9 czerwca 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 czerwca 2016

Pierwszy wysłany (Oszacować)

14 czerwca 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 kwietnia 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 kwietnia 2017

Ostatnia weryfikacja

1 kwietnia 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CLASS-Safety study - Part 2

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