Type 1 DiabetesPhase 2NCT02490098
Closed-loop Control of Postprandial Glucose Levels in Children and Adults With Type 1 Diabetes
A Phase 2 study testing 6-day intervention with sensor-augmented pump therapy, 6-day intervention with single-hormone closed-loop strategy and 6-day intervention with dual-hormone closed-loop strategy in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
Current intensive insulin therapy in T1D involves prandial insulin boluses depending on the carbohydrate content of each ingested meal. Carbohydrate content of ingested meals is the main determinant of post-meal glucose excursion. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- 6-day intervention with sensor-augmented pump therapy, 6-day intervention with single-hormone closed-loop strategy and 6-day intervention with dual-hormone closed-loop strategy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2018to Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females ≥ 8 years 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 and currently using a fast actin insulin analog (Lispro, Aspart or Guilisine).
- Last (less than 3 months) HbA1c ≤ 10%.
- Currently using carbohydrate counting as the meal insulin dose strategy.
- Live in the area of Montreal
Who cannot join
- 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.
- Pregnancy.
- Severe hypoglycemic episode within 1 month of screening.
- 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.
- 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.
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- 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).
- Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).
- Living or planned travel outside Montreal (> 1h of driving) area during closed-loop procedures.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
About this study
Official title: An Open-label, Randomized, Five-way, Cross-over Study to Compare the Efficacy of Single- and Dual-hormone Closed-loop Operations Combined With Either Conventional Carbohydrate Counting or a Simplified Qualitative Meal-size Estimation, and Sensor-augmented Pump Therapy in Regulating Glucose Levels in Children and Adults With Type 1 Diabetes
Current intensive insulin therapy in T1D involves prandial insulin boluses depending on the carbohydrate content of each ingested meal. Carbohydrate content of ingested meals is the main determinant of post-meal glucose excursion. Therefore, accurate carbohydrate counting is a critical aspect of managing postprandial blood glucose levels in type 1 diabetes in order to avoid too much or too little insulin resulting in hypoglycemia and hyperglycemia, respectively. Precision of carbohydrate counting is associated with better glycemic control. However, accurate carbohydrate counting is a challenging task for many patients with type 1 diabetes. Recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward "closed-loop'' strategies to regulate glucose levels in patients with type 1 diabetes. In a closed-loop strategy, the pump insulin infusion rate is altered based on a computer generated recommendation that rely on continuous glucose sensor readings. A dual-hormone closed-loop strategy has also been recently proposed to regulate glucose levels. In a dual-hormone strategy, subcutaneous insulin delivery is accompanied by subcutaneous glucagon infusion. Postprandial meal glucose control with closed-loop strategy still needs some improvements. The objective of this study is to test in outpatient unrestricted settings whether, in the context of closed-loop strategy, conventional meal carbohydrate counting could be reduced to a simplified qualitative meal size estimation without a significant degradation in overall glycemic control in children and adult patients with type 1 diabetes. The investigators hypothesize that 1) dual-hormone closed-loop strategy with qualitative meal size estimation is equivalent to dual-hormone closed-loop strategy with CHO counting in terms of mean glucose; 2) single-hormone closed-loop strategy with qualitative meal size estimation is equivalent to single-hormone closed-loop strategy with CHO counting in terms of mean glucose;
- Conditions
- Type 1 Diabetes
- Being tested
- 6-day intervention with sensor-augmented pump therapy, 6-day intervention with single-hormone closed-loop strategy, 6-day intervention with dual-hormone closed-loop strategy, Insulin, Glucagon
- Keywords
- Type 1 diabetes, Closed-loop system, Artificial pancreas, Insulin, Glucagon, Hypoglycemia, Postprandial glucose
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-day intervention with sensor-augmented pump therapyOther
One day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. Participants will adjust their insulin delivery as per their standard practice; including temporary basal and correction boluses. Participants will have access to their finger-stick glucose measurements and will be advised to measure their glucose level as per their standard practice. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol. Participants will use sensor-augmented pump therapy for 6 days.
6-day intervention with single-hormone closed-loop strategyOther
One day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. On the first day of the intervention, participants will be admitted to the clinical research facility in the morning. A team member will review with the participant how to use study devices. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be allowed to go home in the afternoon. They will be advised to continue with study intervention at home for the next 5 days. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol.
6-day intervention with dual-hormone closed-loop strategyOther
One day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. On the first day of the intervention, participants will be admitted to the clinical research facility in the morning. Participants will have to install a second pump containing glucagon. A team member will review with the participant how to use study devices. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be allowed to go home in the afternoon. They will be advised to continue with study intervention at home for the next 5 days. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol.
InsulinDrug
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)
GlucagonDrug
Glucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.
Continuous Glucose Monitoring System Enlite sensor®, MedtronicDevice
Enlite sensor®, Medtronic
Insulin pump MiniMed® Paradigm® Veo™, MedtronicDevice
MiniMed® Paradigm® Veo™, Medtronic
| Study group | Role | What they receive |
|---|---|---|
| Single-hormone closed-loop strategy with full boluses | Active comparator | Variable subcutaneous insulin infusion rates will be used to regulate postprandial glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Glulisine) will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to the Smartphone platform, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump. Each subject insulin-to-carbohydrate ratio will be used to calculate the insulin bolus to be given. Receives: Other: 6-day intervention with single-hormone closed-loop strategy; Drug: Insulin; Device: Continuous Glucose Monitoring System Enlite sensor®, Medtronic; Device: Insulin pump MiniMed® Paradigm® Veo™, Medtronic |
| Dual-hormone closed-loop strategy with full boluses | Active comparator | Variable subcutaneous insulin and glucagon infusion rates will be used to regulate postprandial glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Glulisine) and Glucagon (Eli Lilly) will be infused using two separate subcutaneous infusion pumps (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to the Smartphone platform, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pumps. Each subject insulin-to-carbohydrate ratio will be used to calculate the insulin bolus to be given. Receives: Other: 6-day intervention with dual-hormone closed-loop strategy; Drug: Insulin; Drug: Glucagon; Device: Continuous Glucose Monitoring System Enlite sensor®, Medtronic; Device: Insulin pump MiniMed® Paradigm® Veo™, Medtronic |
| Single-hormone closed-loop strategy with partial boluses | Active comparator | Variable subcutaneous insulin infusion rates will be used to regulate postprandial glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Glulisine) will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to the Smartphone platform, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump. The partial bolus will be based on the estimated meal size (snack-regular-large-very large). For this strategy, meal size will be defined as: snack as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, very large meal for anything above 90g CHO. The meal size assessment will be done by the patient. Receives: Other: 6-day intervention with single-hormone closed-loop strategy; Drug: Insulin; Device: Continuous Glucose Monitoring System Enlite sensor®, Medtronic; Device: Insulin pump MiniMed® Paradigm® Veo™, Medtronic |
| Dual-hormone closed-loop strategy with partial boluses | Active comparator | Variable subcutaneous insulin and glucagon infusion rates will be used to regulate postprandial glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) and Glucagon (Eli Lilly) will be infused using two separate subcutaneous infusion pumps (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to the Smartphone platform, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pumps. The partial bolus will be based on the estimated meal size (snack-regular-large-very large). For this strategy, meal size will be defined as: snack as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, very large meal for anything above 90g CHO. The meal size assessment will be done by the patient. Receives: Other: 6-day intervention with dual-hormone closed-loop strategy; Drug: Insulin; Drug: Glucagon; Device: Continuous Glucose Monitoring System Enlite sensor®, Medtronic; Device: Insulin pump MiniMed® Paradigm® Veo™, Medtronic |
| Sensor-augmented pump therapy | Active comparator | Subjects will use sensor-augmented pump therapy and freely implement their usual basal rate and CHO-matching full prandial bolus to regulate glucose levels. Patient's usual fast acting insulin analog will be infused using a subcutaneous insulin infusion pump. Each subject insulin-to-carbohydrate ratio will be used to calculate the insulin bolus to be given. Receives: Other: 6-day intervention with sensor-augmented pump therapy; Drug: Insulin; Device: Continuous Glucose Monitoring System Enlite sensor®, Medtronic; Device: Insulin pump MiniMed® Paradigm® Veo™, Medtronic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean day-and-night glucose levels
Measured: 6 days
Secondary outcomes (14)
Percentage of time of glucose levels between 4.0 and 8.0 mmol/L
Measured: 6 days
Percentage of time of glucose levels between 4.0 and 10.0 mmol/L
Measured: 6 days
Percentage of time of glucose levels above 10.0 mmol/L
Measured: 6 days
Percentage of time of glucose levels above 14.0 mmol/L
Measured: 6 days
Percentage of time of glucose levels spent below 4.0 mmol/L
Measured: 6 days
Percentage of time of glucose levels spent below 3.1 mmol/L
Measured: 6 days
Area under the curve of glucose values below 4.0 mmol/L
Measured: 6 days
Area under the curve of glucose values below 3.1 mmol/L
Measured: 6 days
Number of patients with at least one hypoglycemic event below 3.1 mmol/L with or without symptoms
Measured: 6 days
Total number of hypoglycemic event below 3.1 mmol/L
Measured: 6 days
Total insulin delivery
Measured: 6 days
Total glucagon delivery
Measured: 6 days
Standard deviation of glucose levels
Measured: 6 days
Total carbohydrate intake
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJan 2018 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: Funding terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Rémi Rabasa-Lhoret, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490098
- Sponsor's protocol ID
- CLASS-13
- Status last verified
- Oct 2017
- First submitted
- 1 Jul 2015
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Five-way, Cross-over Study to Compare the Efficacy of Single- and Dual-hormone Closed-loop Operations Combined With Either Conventional Carbohydrate Counting or a Simplified Qualitative Meal-size Estimation, and Sensor-augmented Pump Therapy in Regulating Glucose Levels in Children and Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02490098
- Acronym / sponsor ID
- CLASS-13
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Closed-loop system, Artificial pancreas, Insulin, Glucagon, Hypoglycemia, Postprandial glucose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current intensive insulin therapy in T1D involves prandial insulin boluses depending on the carbohydrate content of each ingested meal. Carbohydrate content of ingested meals is the main determinant of post-meal glucose excursion. Therefore, accurate carbohydrate counting is a critical aspect of managing postprandial blood glucose levels in type 1 diabetes in order to avoid too much or too little insulin resulting in hypoglycemia and hyperglycemia, respectively. Precision of carbohydrate counting is associated with better glycemic control. However, accurate carbohydrate counting is a challenging task for many patients with type 1 diabetes. Recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward "closed-loop'' strategies to regulate glucose levels in patients with type 1 diabetes. In a closed-loop strategy, the pump insulin infusion rate is altered based on a computer generated recommendation that rely on continuous glucose sensor readings. A dual-hormone closed-loop strategy has also been recently proposed to regulate glucose levels. In a dual-hormone strategy, subcutaneous insulin delivery is accompanied by subcutaneous glucagon infusion. Postprandial meal glucose control with closed-loop strategy still needs some improvements. The objective of this study is to test in outpatient unrestricted settings whether, in the context of closed-loop strategy, conventional meal carbohydrate counting could be reduced to a simplified qualitative meal size estimation without a significant degradation in overall glycemic control in children and adult patients with type 1 diabetes. The investigators hypothesize that 1) dual-hormone closed-loop strategy with qualitative meal size estimation is equivalent to dual-hormone closed-loop strategy with CHO counting in terms of mean glucose; 2) single-hormone closed-loop strategy with qualitative meal size estimation is equivalent to single-hormone closed-loop strategy with CHO counting in terms of mean glucose;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single-hormone closed-loop strategy with full boluses | Active comparator | Other: 6-day intervention with single-hormone closed-loop strategy, Drug: Insulin, Device: Continuous Glucose Monitoring System Enlite sensor®, Medtronic, Device: Insulin pump MiniMed® Paradigm® Veo™, MedtronicVariable subcutaneous insulin infusion rates will be used to regulate postprandial glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Glulisine) will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to the Smartphone platform, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump. Each subject insulin-to-carbohydrate ratio will be used to calculate the insulin bolus to be given. |
| Dual-hormone closed-loop strategy with full boluses | Active comparator | Other: 6-day intervention with dual-hormone closed-loop strategy, Drug: Insulin, Drug: Glucagon, Device: Continuous Glucose Monitoring System Enlite sensor®, Medtronic, Device: Insulin pump MiniMed® Paradigm® Veo™, MedtronicVariable subcutaneous insulin and glucagon infusion rates will be used to regulate postprandial glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Glulisine) and Glucagon (Eli Lilly) will be infused using two separate subcutaneous infusion pumps (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to the Smartphone platform, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pumps. Each subject insulin-to-carbohydrate ratio will be used to calculate the insulin bolus to be given. |
| Single-hormone closed-loop strategy with partial boluses | Active comparator | Other: 6-day intervention with single-hormone closed-loop strategy, Drug: Insulin, Device: Continuous Glucose Monitoring System Enlite sensor®, Medtronic, Device: Insulin pump MiniMed® Paradigm® Veo™, MedtronicVariable subcutaneous insulin infusion rates will be used to regulate postprandial glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Glulisine) will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to the Smartphone platform, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump. The partial bolus will be based on the estimated meal size (snack-regular-large-very large). For this strategy, meal size will be defined as: snack as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, very large meal for anything above 90g CHO. The meal size assessment will be done by the patient. |
| Dual-hormone closed-loop strategy with partial boluses | Active comparator | Other: 6-day intervention with dual-hormone closed-loop strategy, Drug: Insulin, Drug: Glucagon, Device: Continuous Glucose Monitoring System Enlite sensor®, Medtronic, Device: Insulin pump MiniMed® Paradigm® Veo™, MedtronicVariable subcutaneous insulin and glucagon infusion rates will be used to regulate postprandial glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) and Glucagon (Eli Lilly) will be infused using two separate subcutaneous infusion pumps (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to the Smartphone platform, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pumps. The partial bolus will be based on the estimated meal size (snack-regular-large-very large). For this strategy, meal size will be defined as: snack as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, very large meal for anything above 90g CHO. The meal size assessment will be done by the patient. |
| Sensor-augmented pump therapy | Active comparator | Other: 6-day intervention with sensor-augmented pump therapy, Drug: Insulin, Device: Continuous Glucose Monitoring System Enlite sensor®, Medtronic, Device: Insulin pump MiniMed® Paradigm® Veo™, MedtronicSubjects will use sensor-augmented pump therapy and freely implement their usual basal rate and CHO-matching full prandial bolus to regulate glucose levels. Patient's usual fast acting insulin analog will be infused using a subcutaneous insulin infusion pump. Each subject insulin-to-carbohydrate ratio will be used to calculate the insulin bolus to be given. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females ≥ 8 years 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 and currently using a fast actin insulin analog (Lispro, Aspart or Guilisine).
- Last (less than 3 months) HbA1c ≤ 10%.
- Currently using carbohydrate counting as the meal insulin dose strategy.
Key exclusion criteria (9 listed)
- 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.
- Pregnancy.
- Severe hypoglycemic episode within 1 month of screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-day intervention with sensor-augmented pump therapyOne day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. Participants will adjust their insulin delivery as per their standard practice; including temporary basal and correction boluses. Participants will have access to their finger-stick glucose measurements and will be advised to measure their glucose level as per their standard practice. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol. Participants will use sensor-augmented pump therapy for 6 days. | Other | Sensor-augmented pump therapy |
| 6-day intervention with single-hormone closed-loop strategyOne day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. On the first day of the intervention, participants will be admitted to the clinical research facility in the morning. A team member will review with the participant how to use study devices. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be allowed to go home in the afternoon. They will be advised to continue with study intervention at home for the next 5 days. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol. | Other | Single-hormone closed-loop strategy with full boluses, Single-hormone closed-loop strategy with partial boluses |
| 6-day intervention with dual-hormone closed-loop strategyOne day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. On the first day of the intervention, participants will be admitted to the clinical research facility in the morning. Participants will have to install a second pump containing glucagon. A team member will review with the participant how to use study devices. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be allowed to go home in the afternoon. They will be advised to continue with study intervention at home for the next 5 days. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol. | Other | Dual-hormone closed-loop strategy with full boluses, Dual-hormone closed-loop strategy with partial boluses |
| InsulinParticipant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra) | Drug | Dual-hormone closed-loop strategy with full boluses, Dual-hormone closed-loop strategy with partial boluses, Sensor-augmented pump therapy, Single-hormone closed-loop strategy with full boluses, Single-hormone closed-loop strategy with partial boluses |
| GlucagonGlucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy. | Drug | Dual-hormone closed-loop strategy with full boluses, Dual-hormone closed-loop strategy with partial boluses |
| Continuous Glucose Monitoring System Enlite sensor®, MedtronicEnlite sensor®, Medtronic | Device | Dual-hormone closed-loop strategy with full boluses, Dual-hormone closed-loop strategy with partial boluses, Sensor-augmented pump therapy, Single-hormone closed-loop strategy with full boluses, Single-hormone closed-loop strategy with partial boluses |
| Insulin pump MiniMed® Paradigm® Veo™, MedtronicMiniMed® Paradigm® Veo™, Medtronic | Device | Dual-hormone closed-loop strategy with full boluses, Dual-hormone closed-loop strategy with partial boluses, Sensor-augmented pump therapy, Single-hormone closed-loop strategy with full boluses, Single-hormone closed-loop strategy with partial boluses |
Primary outcome
Mean day-and-night glucose levels
Time frame: 6 days
14 secondary outcomes
Percentage of time of glucose levels between 4.0 and 8.0 mmol/L
Time frame: 6 days
Percentage of time of glucose levels between 4.0 and 10.0 mmol/L
Time frame: 6 days
Percentage of time of glucose levels above 10.0 mmol/L
Time frame: 6 days
Percentage of time of glucose levels above 14.0 mmol/L
Time frame: 6 days
Percentage of time of glucose levels spent below 4.0 mmol/L
Time frame: 6 days
Percentage of time of glucose levels spent below 3.1 mmol/L
Time frame: 6 days
Area under the curve of glucose values below 4.0 mmol/L
Time frame: 6 days
Area under the curve of glucose values below 3.1 mmol/L
Time frame: 6 days
Number of patients with at least one hypoglycemic event below 3.1 mmol/L with or without symptoms
Time frame: 6 days
Total number of hypoglycemic event below 3.1 mmol/L
Time frame: 6 days
Total insulin delivery
Time frame: 6 days
Total glucagon delivery
Time frame: 6 days
Standard deviation of glucose levels
Time frame: 6 days
Total carbohydrate intake
Time frame: 6 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémi Rabasa-Lhoret principal investigator
Institut de Recherches Cliniques de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 6-day intervention with sensor-augmented pump therapy, 6-day intervention with single-hormone closed-loop strategy and 6-day intervention with dual-hormone closed-loop strategy in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean day-and-night glucose levels (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.