Diabetes Mellitus, Type 1NCT02909829
Safety and Efficacy of Artificial Pancreas With and Without a Meal Detection Module on Glycemic Control in Adolescents With Type 1 Diabetes After a Missed Bolus
A study testing Closed Loop Delivery, Closed Loop Delivery with Meal Detection Module and Conventional Pump Therapy in people with Diabetes Mellitus, Type 1, run by McGill University at 1 site in Canada.
Trial summary
Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a good range is a difficult task. A primary source for poor glucose control in adolescents is skipping insulin boluses at mealtimes. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Closed Loop Delivery, Closed Loop Delivery with Meal Detection Module and Conventional Pump Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2017to 11 Oct 2019
- Phase
- Interventional
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes for at least 12 months. (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- The participant will have been on insulin pump therapy for at least 3 months.
- HbA1c 7.5% to 12%.
- Self-reported or documented history of missed-bolus for meals during the previous 6 months.
Who cannot join
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Severe hypoglycemic episode within one month of screening.
- Pregnancy.
- Current use of oral glucocorticoid medication (except low stable dose). Stable doses of inhaled steroids are acceptable.
- Known or suspected allergy to the trial products, including the meal content.
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Three-way, Crossover Study to Assess the Safety and Efficacy of Closed-loop Delivery With and Without Meal Detection Module and Conventional Pump Therapy in Regulating Glucose Levels After a Missed Bolus in Adolescents With Type 1 Diabetes in Inpatient Settings
Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a good range is a difficult task. A primary source for poor glucose control in adolescents is skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the research towards closed-loop delivery systems to automatically regulate glucose levels. Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. The performance of a closed-loop delivery after a missed bolus may be improved if the computer program that calculates the insulin is enhanced with a meal detection module. The meal detection module will automatically detect the meal (which had no bolus delivered), and signal the delivery of more insulin.
The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and without meal detection module compared to conventional pump therapy in regulating post-prandial glycemic levels after omission of a meal bolus.
The primary hypothesis is that closed-loop delivery with no meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.
Read the detailed description
Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a good range is a difficult task. A primary source for poor glucose control in adolescents is skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the research towards closed-loop delivery systems to automatically regulate glucose levels. Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. The performance of a closed-loop delivery after a missed bolus may be improved if the computer program that calculates the insulin is enhanced with a meal detection module. The meal detection module will automatically detect the meal (which had no bolus delivered), and signal the delivery of more insulin.
The aim of this study is to conduct a randomized, three-way, cross-over trial to compare the efficacy of closed-loop delivery, closed-loop delivery with a meal detection module, and conventional pump therapy. The study aims to compare these three interventions for 9 hours in adolescents with poorly controlled type 1 diabetes.
Each 9 hours will include two meals of different carbohydrate content, of which one will not have a carbohydrate-matched prandial bolus. This study will allow for the assessment of the safety and efficacy of closed-loop delivery with and without a meal detection module compared to conventional pump therapy in regulating post-prandial glycaemia.
The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and without meal detection module compared to conventional pump therapy in regulating post-prandial glycemic levels after omission of a meal bolus.
The primary hypothesis is that closed-loop delivery with no meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.
The secondary hypotheses are:
- Closed-loop delivery with meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.
- Closed-loop delivery with meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to closed-loop delivery with no meal detection module.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Closed Loop Delivery, Closed Loop Delivery with Meal Detection Module, Conventional Pump Therapy
- Keywords
- Diabetes Mellitus, Type 1, Artificial Pancreas, Closed-Loop Delivery, Insulin, Adolescent, Missed Bolus
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Loop DeliveryDevice
Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm.
Closed Loop Delivery with Meal Detection ModuleDevice
Closed Loop Delivery with Meal Detection Module Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm with an overlying meal detection module which detects missed meals and will increase insulin infusion rates based on a predictive meal detection algorithm
Conventional Pump TherapyDevice
Insulin will be delivered by subcutaneous insulin infusion pump with participants usual infusion rate
| Study group | Role | What they receive |
|---|---|---|
| Closed Loop Delivery | Experimental | Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm. Participants will eat breakfast and bolus, then eat lunch and not bolus. Receives: Device: Closed Loop Delivery |
| Closed Loop Delivery with Meal Detection Module | Experimental | Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm with an overlying meal detection module which detects missed meals and will increase insulin infusion rates based on a predictive meal detection algorithm. Participants will eat breakfast and bolus, then eat lunch and not bolus. Receives: Device: Closed Loop Delivery with Meal Detection Module |
| Conventional Pump Therapy | Active comparator | Insulin will be delivered by subcutaneous insulin infusion pump with participants usual infusion rate. Participants will eat breakfast and bolus as per usual, then eat lunch and not bolus. Receives: Device: Conventional Pump Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinc: The incremental area under the curve (as compared to pre-meal glucose value) of the postprandial glucose excursions for the lunch meal.
Measured: 0 - 240 min postprandial lunch meal
Secondary outcomes (9)
AUCinc: The incremental area under the curve (as compared to pre-meal glucose value) of the postprandial glucose excursions: a. >10.0 mmol/L; b. >13.9 mmol/L; c. >16.7 mmol/L
Measured: 0 - 240 min postprandial lunch meal
Percentage of postprandial time of sensor glucose measurements spent: a. <3.9 mmol/L; b. between 3.9 and 7.8 mmol/L; c. between 3.9 and 10.0 mmol/L; d. >10.0 mmol/L; e. >13.9 mmol/L; f. >16.7 mmol/L.
Measured: 0 - 240 min postprandial lunch meal
Mean sensor glucose concentration.
Measured: 9 hours
Total insulin delivery
Measured: 9 hours
Glucose concentration as measured by CGM at 2 hours (120 min) post-meal.
Measured: 120 min postprandial lunch meal
Incremental glucose concentration as measured by CGM at 2 hours (120 min) post-meal.
Measured: 120 min postprandial lunch meal
Incremental postprandial peak of glucose concentration as measured by CGM.
Measured: 0 - 240 min postprandial lunch meal
Number of hyperglycemic events > 18.0mmol/L.
Measured: 0 - 240 min postprandial lunch meal
1. Glucose concentration as measured by CGM at 5 hours (300 min) post-meal. Glucose concentration as measured by CGM at 5 hours (300 min) post-meal
Measured: 300 min postprandial lunch meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start31 Oct 2017
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Haidar, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909829
- Sponsor's protocol ID
- Missed Bolus 9h
- Status last verified
- May 2020
- First submitted
- 1 Sep 2016
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Three-way, Crossover Study to Assess the Safety and Efficacy of Closed-loop Delivery With and Without Meal Detection Module and Conventional Pump Therapy in Regulating Glucose Levels After a Missed Bolus in Adolescents With Type 1 Diabetes in Inpatient Settings
- ClinicalTrials.gov ID
- NCT02909829
- Acronym / sponsor ID
- Missed Bolus 9h
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, Artificial Pancreas, Closed-Loop Delivery, Insulin, Adolescent, Missed Bolus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 21 Sep 2016 (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.
Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a good range is a difficult task. A primary source for poor glucose control in adolescents is skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the research towards closed-loop delivery systems to automatically regulate glucose levels. Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. The performance of a closed-loop delivery after a missed bolus may be improved if the computer program that calculates the insulin is enhanced with a meal detection module. The meal detection module will automatically detect the meal (which had no bolus delivered), and signal the delivery of more insulin.
The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and without meal detection module compared to conventional pump therapy in regulating post-prandial glycemic levels after omission of a meal bolus.
The primary hypothesis is that closed-loop delivery with no meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.
Detailed description
Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a good range is a difficult task. A primary source for poor glucose control in adolescents is skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the research towards closed-loop delivery systems to automatically regulate glucose levels. Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. The performance of a closed-loop delivery after a missed bolus may be improved if the computer program that calculates the insulin is enhanced with a meal detection module. The meal detection module will automatically detect the meal (which had no bolus delivered), and signal the delivery of more insulin.
The aim of this study is to conduct a randomized, three-way, cross-over trial to compare the efficacy of closed-loop delivery, closed-loop delivery with a meal detection module, and conventional pump therapy. The study aims to compare these three interventions for 9 hours in adolescents with poorly controlled type 1 diabetes.
Each 9 hours will include two meals of different carbohydrate content, of which one will not have a carbohydrate-matched prandial bolus. This study will allow for the assessment of the safety and efficacy of closed-loop delivery with and without a meal detection module compared to conventional pump therapy in regulating post-prandial glycaemia.
The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and without meal detection module compared to conventional pump therapy in regulating post-prandial glycemic levels after omission of a meal bolus.
The primary hypothesis is that closed-loop delivery with no meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.
The secondary hypotheses are:
- Closed-loop delivery with meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.
- Closed-loop delivery with meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to closed-loop delivery with no meal detection module.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Closed Loop Delivery | Experimental | Device: Closed Loop DeliveryInsulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm. Participants will eat breakfast and bolus, then eat lunch and not bolus. |
| Closed Loop Delivery with Meal Detection Module | Experimental | Device: Closed Loop Delivery with Meal Detection ModuleInsulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm with an overlying meal detection module which detects missed meals and will increase insulin infusion rates based on a predictive meal detection algorithm. Participants will eat breakfast and bolus, then eat lunch and not bolus. |
| Conventional Pump Therapy | Active comparator | Device: Conventional Pump TherapyInsulin will be delivered by subcutaneous insulin infusion pump with participants usual infusion rate. Participants will eat breakfast and bolus as per usual, then eat lunch and not bolus. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of type 1 diabetes for at least 12 months. (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- The participant will have been on insulin pump therapy for at least 3 months.
- HbA1c 7.5% to 12%.
- Self-reported or documented history of missed-bolus for meals during the previous 6 months.
Key exclusion criteria (7 listed)
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Severe hypoglycemic episode within one month of screening.
- Pregnancy.
- Current use of oral glucocorticoid medication (except low stable dose). Stable doses of inhaled steroids are acceptable.
- Known or suspected allergy to the trial products, including the meal content.
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 |
|---|---|---|
| Closed Loop DeliveryInsulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm. | Device | Closed Loop Delivery |
| Closed Loop Delivery with Meal Detection ModuleClosed Loop Delivery with Meal Detection Module Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm with an overlying meal detection module which detects missed meals and will increase insulin infusion rates based on a predictive meal detection algorithm | Device | Closed Loop Delivery with Meal Detection Module |
| Conventional Pump TherapyInsulin will be delivered by subcutaneous insulin infusion pump with participants usual infusion rate | Device | Conventional Pump Therapy |
Primary outcome
AUCinc: The incremental area under the curve (as compared to pre-meal glucose value) of the postprandial glucose excursions for the lunch meal.
Time frame: 0 - 240 min postprandial lunch meal
9 secondary outcomes
AUCinc: The incremental area under the curve (as compared to pre-meal glucose value) of the postprandial glucose excursions: a. >10.0 mmol/L; b. >13.9 mmol/L; c. >16.7 mmol/L
Time frame: 0 - 240 min postprandial lunch meal
Percentage of postprandial time of sensor glucose measurements spent: a. <3.9 mmol/L; b. between 3.9 and 7.8 mmol/L; c. between 3.9 and 10.0 mmol/L; d. >10.0 mmol/L; e. >13.9 mmol/L; f. >16.7 mmol/L.
Time frame: 0 - 240 min postprandial lunch meal
Mean sensor glucose concentration.
Time frame: 9 hours
Total insulin delivery
Time frame: 9 hours
Glucose concentration as measured by CGM at 2 hours (120 min) post-meal.
Time frame: 120 min postprandial lunch meal
Incremental glucose concentration as measured by CGM at 2 hours (120 min) post-meal.
Time frame: 120 min postprandial lunch meal
Incremental postprandial peak of glucose concentration as measured by CGM.
Time frame: 0 - 240 min postprandial lunch meal
Number of hyperglycemic events > 18.0mmol/L.
Time frame: 0 - 240 min postprandial lunch meal
1. Glucose concentration as measured by CGM at 5 hours (300 min) post-meal. Glucose concentration as measured by CGM at 5 hours (300 min) post-meal
Time frame: 300 min postprandial lunch meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Loop Delivery, Closed Loop Delivery with Meal Detection Module and Conventional Pump Therapy in people with Diabetes Mellitus, Type 1, run by McGill University 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 27 May 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUCinc: The incremental area under the curve (as compared to pre-meal glucose value) of the postprandial glucose excursions for the lunch meal. (time frame: 0 - 240 min postprandial lunch meal). 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 May 2020.