Closed-loop Control of Glucose Levels After Meal Intake in Adults With Type 1 Diabetes
An Open-label, Randomized, Three-way, Cross-over Study to Compare the Efficacy of Closed-loop Operation Combined With Meal-and-carbohydrate-announcement Closed-loop Operation Combined With Meal-announcement, and Conventional Pump Therapy in Regulating 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 dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The objective of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control.
Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than conventional pump treatment in regulation of glucose levels in adults with T1D.
Studieöversikt
Detaljerad beskrivning
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.
Each patient will be admitted three times to a clinical research facility. In the meal-and-carbohydrate-announcement visit, patients will eat 3 meals accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the meal-announcement visit, patients will eat the 3 same meals but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. In the control visit, patients will use conventional pump therapy to regulate glucose levels.
Studietyp
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Fas
- Fas 2
Kontakter och platser
Studieorter
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Quebec
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Montreal, Quebec, Kanada, H2W1R7
- Institut de recherches cliniques de Montréal
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Beskrivning
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 3 months.
- Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria:
- 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.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Medication likely to affect with the interpretation of the results because of their well known impact on gastric emptying: Motilium®, Prandase®, Victoza®, Byetta® and Symlin®.
- Known or suspected allergy to the trial products, meal contents including nuts, peanuts, dairy products or eggs.
- Unusual nutritional habits (e.g. vegetarians)
- 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 snack, not willing to change pump parameters, etc).
- Unreliable carbohydrate counting or lack of insulin to carbohydrate ratios
- Problems with venous access
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: CHO-dependant bolus
An insulin bolus dependant of carbohydrate content will be given after each meal. Each subject insulin-to-carbohydrate ratio (U per 10g CHO) will be used to calculate the insulin bolus to be given. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings. |
Subjects will be admitted at the IRCM at 6:30.
Subjects will be asked to fast from midnight.
At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served.
At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served.
At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served.
Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
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Aktiv komparator: CHO-independent bolus
An insulin bolus independent of carbohydrate content will be given after each meal.
The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.
|
Subjects will be admitted at the IRCM at 6:30.
Subjects will be asked to fast from midnight.
At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served.
At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served.
At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served.
Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
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Aktiv komparator: Conventional treatment
Patients will use conventional pump therapy to regulate glucose levels
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Subjects will be admitted at the IRCM at 6:30.
Subjects will be asked to fast from midnight.
At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served.
At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served.
At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served.
Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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The positive incremental area under the curve of postprandial glucose excursions
Tidsram: 4 hours after meal intake
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The positive incremental area under the curve (IAUC, as compared to pre-meal glucose value) of the 4-hr postprandial glucose excursions for the breakfast, lunch and dinner meals.
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4 hours after meal intake
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Mean plasma glucose
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Incremental two hours postprandial glucose
Tidsram: 2 hours after meal intake
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2 hours after meal intake
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Incremental postprandial peak-glucose values
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Percentage of time of plasma glucose levels between 4.0 and 10.0 mmol/L
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Percentage of time of plasma glucose levels spent above 10.0 mmol/L
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Percentage of time of plasma glucose levels spent below 4.0 mmol/L
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Total insulin delivery
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Total glucagon delivery
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Standard deviation of glucose levels
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Percentage of time of plasma glucose concentrations below 3.5 mmol/L
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Percentage of time of plasma glucose concentrations above 14 mmol/L
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Mean plasma insulin concentration
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Mean plasma glucagon concentration
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Number of patients experiencing hypoglycemia requiring oral treatment
Tidsram: 8h00 to 21h00
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8h00 to 21h00
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Incremental area under the curve of the 4-hr postprandial glucose excursions but the reference glucose is set to 5.0 mmol/L if premeal glucose is less than 5.0 mmol/L.
Tidsram: 4 hours after meal intake
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4 hours after meal intake
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Andra studie-ID-nummer
- CLASS-05
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