Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels
An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels in 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.
The objective of this pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.
Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.
Přehled studie
Postavení
Podmínky
Typ studie
Fáze
- Fáze 2
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 6 months.
- HbA1c ≤ 12%.
Exclusion Criteria:
- Using a patch-pump (e.g. Omnipod)
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Ongoing or planned pregnancy.
- Breastfeeding.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
- Known or suspected allergy to the trial products or meal contents.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
- Problems with venous access.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
|
The participant's insulin pump will be used to infuse insulin
The Dexcom G4 Platinum will be used to measure glucose levels
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes. |
|
Aktivní komparátor: Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
|
The participant's insulin pump will be used to infuse insulin
The Dexcom G4 Platinum will be used to measure glucose levels
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Change in plasma glucose levels 1 hour after the meal
Časové okno: 1 hour
|
1 hour
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
Časové okno: 1 hour
|
1 hour
|
|
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
Časové okno: 2 hours
|
2 hours
|
|
Plasma glucose level 1 hour after the meal.
Časové okno: 1 hour
|
1 hour
|
|
Plasma glucose level 2 hours after the meal.
Časové okno: 2 hours
|
2 hours
|
|
Glycemic peak in the 3 hours following the meal.
Časové okno: 3 hours
|
3 hours
|
|
Change in plasma glucose levels 2 hours after the meal.
Časové okno: 2 hours
|
2 hours
|
|
Peak time of glucose levels over the 4 hours following the meal.
Časové okno: 4 hours
|
4 hours
|
|
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
Časové okno: 4 hours
|
4 hours
|
|
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 3.9 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 3.9 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 3.3 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 3.3 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 2.8 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 2.8 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 10 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 10 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 13.9 mmol/L
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 13.9 mmol/L
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 16.7 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 16.7 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 3.9 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 3.9 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 3.3 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 3.3 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 2.8 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 2.8 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 10.0 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 10.0 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 13.9 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 13.9 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 16.7 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 16.7 mmol/L.
Časové okno: 11 hours
|
11 hours
|
|
Standard deviation of plasma glucose levels.
Časové okno: 11 hours
|
11 hours
|
|
Standard deviation of sensor glucose levels.
Časové okno: 11 hours
|
11 hours
|
|
Coefficient of variance of plasma glucose levels.
Časové okno: 11 hours
|
11 hours
|
|
Coefficient of variance of sensor glucose levels.
Časové okno: 11 hours
|
11 hours
|
|
Total insulin delivery.
Časové okno: 11 hours
|
11 hours
|
|
Mean plasma glucose level.
Časové okno: 11 hours
|
11 hours
|
|
Mean sensor glucose level.
Časové okno: 11 hours
|
11 hours
|
|
Mean plasma insulin concentration.
Časové okno: 11 hours
|
11 hours
|
|
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
Časové okno: 11 hours
|
11 hours
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CLASS-FiAsp
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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