Closed-loop Control of Overnight Glucose Levels in Adults and Adolescents With Type 1 Diabetes
18 października 2014 zaktualizowane przez: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
An Open-label, Randomized, Three-way, Multicenter Study to Compare the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Insulin Pump Therapy in Regulating Overnight Glucose Levels at Home in Adolescents and Adults With Type 1 Diabetes
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in a out-patient study in adults and adolescents with type 1 diabetes.
The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
We aim to conduct a multicenter study to compare the efficacy of conventional pump therapy, single-hormone closed-loop strategy and dual-hormone closed-loop strategy to regulate overnight glucose levels, at home, in adolescents and adults with type 1 diabetes. Each intervention will be tested on two nights: 1) After a carbohydrate-rich dinner meal (to exaggerate hyperglycemic risk and; 2) After an evening exercise (to exaggerate hypoglycemic risk).
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
28
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Ontario
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Toronto, Ontario, Kanada
- Mount Sinai Hospital
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Quebec
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Montreal, Quebec, Kanada
- Institut de recherches cliniques de Montréal
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Montreal, Quebec, Kanada
- Montreal Children Hospital
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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
12 lat i starsze (Dziecko, Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Males and females aged ≥ 12 years of old.
- Body mass index < 35
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 4 months.
- HbA1c < 12%.
- At least two visits with an endocrinology team in the past 1 year.
Exclusion Criteria:
- Clinically significant nephropathy, neuropathy (peripheral or autonomic e.g. significant gastroparesis) or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled therapy).
- Known or suspected allergy to the insulin aspart, glucagon, Medtronic sensors, or Medtronic infusion sets..
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Anticipating a significant change in treatment regimen between admissions (such as a major change in an exercise routine, significant change in dietary routine or in insulin therapy.
- Failure to comply with team's recommendations.
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: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Conventional insulin pump therapry
Subjects will use conventional pump therapy to regulate their glucose levels.
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At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females).
Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve.
The workout will be on a treadmill and/or a stationary bicycle.
Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
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Aktywny komparator: Single-hormone closed-loop system
Variable subcutaneous insulin infusion rate will be used to regulate glucose levels.
Insulin Aspart (Novorapid) will be infused using a subcutaneous infusion pump.
The glucose level as measured by the real time sensor will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer-generated recommendations of infusion rates.
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At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females).
Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve.
The workout will be on a treadmill and/or a stationary bicycle.
Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
|
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Aktywny komparator: Dual-hormone closed-loop system
Insulin Aspart (Novorapid) and glucagon (Paladin) will be infused using two separate subcutaneous infusion pumps.
The glucose levels as measured by the real time sensor will be entered manually into the computer every 10 minutes.
The pumps' infusion rate will then be changed manually based on the computer generated-recommendation delivery levels.
|
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females).
Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve.
The workout will be on a treadmill and/or a stationary bicycle.
Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of time in target range
Ramy czasowe: 8 hours
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Percentage of time for which glucose levels (as measured by the glucose sensor) are in target range.
Target range is defined to be between 4.0 to 8.0 mmol/L
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8 hours
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of time in target range for each night separately
Ramy czasowe: 8 hours
|
Percentage of time for which glucose levels are in target range for each night separately.
Target range is defined to be between 4.0 and 8.0 mmol/L.
|
8 hours
|
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Percentage of time in target range for the pooled data
Ramy czasowe: 8 hours
|
Percentage of time for which glucose levels are in target range for the pooled data.
Target range is defined to be between 4.0 to 8.0 mmol/L.
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8 hours
|
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Percentage of time spent below 4.0 mmol/L
Ramy czasowe: 8 hours
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Percentage of time for which glucose levels are below 4.0 mmol/L.
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8 hours
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Percentage of time spent below 3.3 mmol/L
Ramy czasowe: 8 hours
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Percentage of time for which glucose levels are spent below 3.3 mmol/L.
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8 hours
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Area under the curve for glucose levels below 4.0 mmol/L
Ramy czasowe: 8 hours
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8 hours
|
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Area under the curve for glucose levels below 3.3 mmol/L
Ramy czasowe: 8 hours
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8 hours
|
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Percentage of time spent above 8.0 mmol/L
Ramy czasowe: 8 hours
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Percentage of time for which glucose levels are above 8.0 mmol/L
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8 hours
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Percentage of time spent above 10.0 mmol/L
Ramy czasowe: 8 hours
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Percentage of time for which glucose levels are above 10.0 mmol/L.
|
8 hours
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Area under the curve for glucose levels spent above 8.0 mmol/L
Ramy czasowe: 8 hours
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8 hours
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Area under the curve for glucose levels spent above 10.0 mmol/L
Ramy czasowe: 8 hours
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8 hours
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Mean glucose levels
Ramy czasowe: 8 hours
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8 hours
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Standard deviation of glucose levels
Ramy czasowe: 8 hours
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Standard deviation of glucose levels as a measure of glucose variability.
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8 hours
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Total insulin delivery
Ramy czasowe: 8 hours
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8 hours
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Number of subjects experiencing at least one hypoglycemic event requiring treatment
Ramy czasowe: 8 hours
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8 hours
|
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Number of hypoglycemic events requiring treatment
Ramy czasowe: 8 hours
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8 hours
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Bruce Perkins, Mount Sinai Hospital
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
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 lipca 2013
Zakończenie podstawowe (Rzeczywisty)
1 września 2014
Ukończenie studiów (Rzeczywisty)
1 września 2014
Daty rejestracji na studia
Pierwszy przesłany
12 lipca 2013
Pierwszy przesłany, który spełnia kryteria kontroli jakości
17 lipca 2013
Pierwszy wysłany (Oszacować)
22 lipca 2013
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
21 października 2014
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 października 2014
Ostatnia weryfikacja
1 października 2014
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CLASS-04
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