Study: NCT04758858

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Insulin treatment optimization with participant's usual diet
Description: Two weeks before the intervention phase, insulin dose optimization and revision of participants' knowledge on carbohydrates counting, hypo- and hyperglycemia prevention and treatment will be done with a nurse and a dietitian under a physician's supervision. Once to twice a week, participants will be contacted to review if glucose values are in target.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Insulin treatment optimization with participant's usual diet
Description: Two weeks before the intervention phase, insulin dose optimization and revision of participants' knowledge on carbohydrates counting, hypo- and hyperglycemia prevention and treatment will be done with a nurse and a dietitian under a physician's supervision. Once to twice a week, participants will be contacted to review if glucose values are in target.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Insulin treatment optimization with participant's usual diet
Description: Two weeks before the intervention phase, insulin dose optimization and revision of participants' knowledge on carbohydrates counting, hypo- and hyperglycemia prevention and treatment will be done with a nurse and a dietitian under a physician's supervision. Once to twice a week, participants will be contacted to review if glucose values are in target.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Abbott's FreeStyle Libre
Description: During the whole trial, blood glucose will be assessed by intermittent scanning Continuous Glucose Monitors (isCGM; Abbott's Freestyle-Libre glucose sensor). Participants will be asked to record or download, in their Freestyle Libre reader or in their insulin pump, their insulin doses being injected each day.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Abbott's FreeStyle Libre
Description: During the whole trial, blood glucose will be assessed by intermittent scanning Continuous Glucose Monitors (isCGM; Abbott's Freestyle-Libre glucose sensor). Participants will be asked to record or download, in their Freestyle Libre reader or in their insulin pump, their insulin doses being injected each day.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Abbott's FreeStyle Libre
Description: During the whole trial, blood glucose will be assessed by intermittent scanning Continuous Glucose Monitors (isCGM; Abbott's Freestyle-Libre glucose sensor). Participants will be asked to record or download, in their Freestyle Libre reader or in their insulin pump, their insulin doses being injected each day.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Three-day food journal
Description: Two weeks before the intervention phase, participants will be asked to complete a 3-day food journal, using the Keenoa mobile application, with carbohydrates (CHO) content of food and blood glucose measures to optimize their insulin doses. Analysis of the food journal will allow us to quantify the participants' usual diet.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Three-day food journal
Description: Two weeks before the intervention phase, participants will be asked to complete a 3-day food journal, using the Keenoa mobile application, with carbohydrates (CHO) content of food and blood glucose measures to optimize their insulin doses. Analysis of the food journal will allow us to quantify the participants' usual diet.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Three-day food journal
Description: Two weeks before the intervention phase, participants will be asked to complete a 3-day food journal, using the Keenoa mobile application, with carbohydrates (CHO) content of food and blood glucose measures to optimize their insulin doses. Analysis of the food journal will allow us to quantify the participants' usual diet.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Medical visit
Description: During visit 1, a short medical interview will be done to establish if the subject is eligible to participate in the study. A list of current medications, presence of complications, as well as comorbidities associated with their diabetes will be collected in their medical file during the visit with the endocrinologist.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Medical visit
Description: During visit 1, a short medical interview will be done to establish if the subject is eligible to participate in the study. A list of current medications, presence of complications, as well as comorbidities associated with their diabetes will be collected in their medical file during the visit with the endocrinologist.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Medical visit
Description: During visit 1, a short medical interview will be done to establish if the subject is eligible to participate in the study. A list of current medications, presence of complications, as well as comorbidities associated with their diabetes will be collected in their medical file during the visit with the endocrinologist.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Blood pressure measurements
Description: Blood pressure (systolic and diastolic blood pressure) will be measured during all visits (visits 1 to 4).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Blood pressure measurements
Description: Blood pressure (systolic and diastolic blood pressure) will be measured during all visits (visits 1 to 4).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Blood pressure measurements
Description: Blood pressure (systolic and diastolic blood pressure) will be measured during all visits (visits 1 to 4).

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Anthropometric parameters measurements
Description: Weight, height, BMI and waist circumference will be measured during all visits (visits 1 to 4).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Anthropometric parameters measurements
Description: Weight, height, BMI and waist circumference will be measured during all visits (visits 1 to 4).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Anthropometric parameters measurements
Description: Weight, height, BMI and waist circumference will be measured during all visits (visits 1 to 4).

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Indirect calorimetry test
Description: Both resting metabolic rate and respiratory quotient will be measured after a 10-hour fast by indirect calorimetry. The test will be done twice, before (visit 2) and after (visit 4) the intervention phase.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Indirect calorimetry test
Description: Both resting metabolic rate and respiratory quotient will be measured after a 10-hour fast by indirect calorimetry. The test will be done twice, before (visit 2) and after (visit 4) the intervention phase.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Indirect calorimetry test
Description: Both resting metabolic rate and respiratory quotient will be measured after a 10-hour fast by indirect calorimetry. The test will be done twice, before (visit 2) and after (visit 4) the intervention phase.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Well-being questionnaire
Description: Participants will be asked to complete a well-being questionnaire (nausea, fatigue, etc) during visits 2, 3 and 4.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Well-being questionnaire
Description: Participants will be asked to complete a well-being questionnaire (nausea, fatigue, etc) during visits 2, 3 and 4.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Well-being questionnaire
Description: Participants will be asked to complete a well-being questionnaire (nausea, fatigue, etc) during visits 2, 3 and 4.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Diet appreciation questionnaire
Description: Participants will be asked to complete a diet appreciation (appetite, fullness, etc) questionnaire during visits 3 and 4.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Diet appreciation questionnaire
Description: Participants will be asked to complete a diet appreciation (appetite, fullness, etc) questionnaire during visits 3 and 4.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Diet appreciation questionnaire
Description: Participants will be asked to complete a diet appreciation (appetite, fullness, etc) questionnaire during visits 3 and 4.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Pedometer (PiezoRxD)
Description: Participants will be asked to wear a pedometer (PiezoRxD) that will record their steps every day during the whole trial. Also, they will have to install Piezo: Achieve the Guidelines!, a free mobile application, on their smartphone or tablet. It will connect to their pedometer via bluetooth and will help the research assistant track their data remotely

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Pedometer (PiezoRxD)
Description: Participants will be asked to wear a pedometer (PiezoRxD) that will record their steps every day during the whole trial. Also, they will have to install Piezo: Achieve the Guidelines!, a free mobile application, on their smartphone or tablet. It will connect to their pedometer via bluetooth and will help the research assistant track their data remotely

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Pedometer (PiezoRxD)
Description: Participants will be asked to wear a pedometer (PiezoRxD) that will record their steps every day during the whole trial. Also, they will have to install Piezo: Achieve the Guidelines!, a free mobile application, on their smartphone or tablet. It will connect to their pedometer via bluetooth and will help the research assistant track their data remotely

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Hepatic imaging (MRI)
Description: Imaging of participants' liver will be done by MRI at the Centre Hospitalier de l'Université de Montréal (CHUM). The test will be done twice, before (visit 2) and after (visit 4) the intervention phase.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Hepatic imaging (MRI)
Description: Imaging of participants' liver will be done by MRI at the Centre Hospitalier de l'Université de Montréal (CHUM). The test will be done twice, before (visit 2) and after (visit 4) the intervention phase.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Hepatic imaging (MRI)
Description: Imaging of participants' liver will be done by MRI at the Centre Hospitalier de l'Université de Montréal (CHUM). The test will be done twice, before (visit 2) and after (visit 4) the intervention phase.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Glucagon efficiency test
Description: The glucagon efficiency test will be done twice, before (visit 2) and after (visit 4) the intervention phase. A subcutaneous insulin injection based on individual insulin correction factor will be given to induce hypoglycemia down to 3 mmol/L (based on plasma glucose). A subcutaneous injection of 300 µg of glucagon will be administered.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Glucagon efficiency test
Description: The glucagon efficiency test will be done twice, before (visit 2) and after (visit 4) the intervention phase. A subcutaneous insulin injection based on individual insulin correction factor will be given to induce hypoglycemia down to 3 mmol/L (based on plasma glucose). A subcutaneous injection of 300 µg of glucagon will be administered.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Glucagon efficiency test
Description: The glucagon efficiency test will be done twice, before (visit 2) and after (visit 4) the intervention phase. A subcutaneous insulin injection based on individual insulin correction factor will be given to induce hypoglycemia down to 3 mmol/L (based on plasma glucose). A subcutaneous injection of 300 µg of glucagon will be administered.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Body composition : Dual Energy X-ray absorptiometry (DEXA)
Description: Lean body mass and fat mass will be measured by Dual Energy X-ray absorptiometry (DEXA). The DEXA test will be done twice, before (visit 2) and after (visit 4) the intervention phase.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Body composition : Dual Energy X-ray absorptiometry (DEXA)
Description: Lean body mass and fat mass will be measured by Dual Energy X-ray absorptiometry (DEXA). The DEXA test will be done twice, before (visit 2) and after (visit 4) the intervention phase.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Body composition : Dual Energy X-ray absorptiometry (DEXA)
Description: Lean body mass and fat mass will be measured by Dual Energy X-ray absorptiometry (DEXA). The DEXA test will be done twice, before (visit 2) and after (visit 4) the intervention phase.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Blood tests
Description: Blood tests will be done to assess participants' diabetes control as well as to assess other biochemical markers (blood lipids as well as markers of inflammation and liver function). Blood will be collected and analyzed during all visits (visits 1 to 4).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Blood tests
Description: Blood tests will be done to assess participants' diabetes control as well as to assess other biochemical markers (blood lipids as well as markers of inflammation and liver function). Blood will be collected and analyzed during all visits (visits 1 to 4).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Blood tests
Description: Blood tests will be done to assess participants' diabetes control as well as to assess other biochemical markers (blood lipids as well as markers of inflammation and liver function). Blood will be collected and analyzed during all visits (visits 1 to 4).

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Stool sample collections (optional)
Description: Participants will be asked to collect and immediately freeze their stool sample until it is given to the study team (for intestinal microbiota composition analysis). This will be done three times during the study, during phase 1, between week 1 and 6 of phase 2 and between week 6 and 12 of phase 2.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Stool sample collections (optional)
Description: Participants will be asked to collect and immediately freeze their stool sample until it is given to the study team (for intestinal microbiota composition analysis). This will be done three times during the study, during phase 1, between week 1 and 6 of phase 2 and between week 6 and 12 of phase 2.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Stool sample collections (optional)
Description: Participants will be asked to collect and immediately freeze their stool sample until it is given to the study team (for intestinal microbiota composition analysis). This will be done three times during the study, during phase 1, between week 1 and 6 of phase 2 and between week 6 and 12 of phase 2.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Hypoglycemia journal
Description: During the whole trial, participants will be asked to keep a log of their hypoglycemia episodes, which are defined by the need to consume CHO. They will be asked to note the time, symptoms (including time taken for disappearance after treatment), capillary glucose measurement and the amount of CHO consumed.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Hypoglycemia journal
Description: During the whole trial, participants will be asked to keep a log of their hypoglycemia episodes, which are defined by the need to consume CHO. They will be asked to note the time, symptoms (including time taken for disappearance after treatment), capillary glucose measurement and the amount of CHO consumed.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Hypoglycemia journal
Description: During the whole trial, participants will be asked to keep a log of their hypoglycemia episodes, which are defined by the need to consume CHO. They will be asked to note the time, symptoms (including time taken for disappearance after treatment), capillary glucose measurement and the amount of CHO consumed.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Ketone journal
Description: During the intervention phase, participants will be asked to measure their ß-hydroxybutarate level (mmol/L) with their Abbott's Freestyle-Libre scanner at least twice per week before breakfast. Participants will be asked to check their ketone bodies for sensor or capillary glucose levels exceeding 15 mmol/l, when their sensor indicates high without a specific glucose value and when they have symptoms of ketoacidosis (regardless of glucose reading).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Ketone journal
Description: During the intervention phase, participants will be asked to measure their ß-hydroxybutarate level (mmol/L) with their Abbott's Freestyle-Libre scanner at least twice per week before breakfast. Participants will be asked to check their ketone bodies for sensor or capillary glucose levels exceeding 15 mmol/l, when their sensor indicates high without a specific glucose value and when they have symptoms of ketoacidosis (regardless of glucose reading).