DiabetesNCT03581968
Efficacy of Closed-Loop Strategy With and Without a Learning Component in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp
A study testing Artificial Pancreas in people with Diabetes and Type 1 Diabetes Mellitus, run by McGill University at 1 site in Canada.
Trial summary
Our lab has developed an artificial pancreas system called the McGill Artificial Pancreas (MAP) for automating insulin delivery. Using patient's basal-bolus parameters (basal rates and ICRs), the artificial pancreas involves a control algorithm that modulates insulin infusion based on the sensor readings and meal… Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Diabetes, Type 1 Diabetes Mellitus
- What is being tested?
- Artificial Pancreas
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jul 2018to 10 Aug 2018
- 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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females between 8 and 21 years old.
- 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 ≤ 11%.
Who cannot join
- Participants who cannot or are unwilling to use NovoRapid (Aspart) insulin or Humalog (Lispro) insulin for the duration of the study.
- 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 the study protocol or with team's recommendations (e.g. not willing to use trial pump, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Two-Way, Cross-Over Study to Compare the Efficacy of Closed-Loop Strategy With and Without a Learning Component in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp
Our lab has developed an artificial pancreas system called the McGill Artificial Pancreas (MAP) for automating insulin delivery. Using patient's basal-bolus parameters (basal rates and ICRs), the artificial pancreas involves a control algorithm that modulates insulin infusion based on the sensor readings and meal information. However, because basal-bolus parameters are difficult to optimize, proper glycemic control is not always achieved. Therefore, we have developed a learning algorithm that estimates optimal basal-bolus parameters using data over several days. The algorithm examines daily glucose, insulin, and meal data to make changes in patients' basal rates and ICRs.
The objective of this project is to test our artificial pancreas system with and without the learning algorithm using a randomized crossover design in between 31 and 67 children and adolescents at camp Carowanis. We hypothesize that adding a learning algorithm to the artificial pancreas will improve the performance of our artificial pancreas system by increasing the time spent in target glucose range (4mmol/L - 10mmol/L) compared with the artificial pancreas system alone.
Read the detailed description
This is an open-label, randomized, two-way, cross-over study to compare the glucose control between closed-loop strategy with and without a learning module. Children and adolescent type 1 diabetes patients at Camp Carowanis will be enrolled in the study, where they will undergo two randomly ordered interventions:
- Closed-loop therapy: participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be determined by the camp's physicians on day 1 of camp. The research staff will update the pump's settings to reflect the physician's recommendations at the beginning of the closed-loop therapy, and each time the physicians update the study parameters. Camp physicians will review participants' sensor and insulin data daily, and if necessary, adjust participant basal rates and ICRs. The research staff members will likewise adjust the pump's basal rates and ICR settings as per physician's recommendations. The closed-loop therapy will last 2 days (48 hours).
- Closed-loop therapy with learning module: participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be computed by the learning algorithm and updated daily. The learning algorithm runs on a computer of the research staff members and requires patient data to calculate the optimal basal rates and ICR. Each morning, the research staff members will upload patient data onto the computer, run the leaning algorithm, and update the pump parameters to reflect the recommendations computed by the learning algorithm. Camp physicians will be to review the algorithm's recommendations before they are entered into the patient's pump. The closed-loop therapy with the learning module will last 8 days (192 hours).
- Conditions
- Diabetes, Type 1 Diabetes Mellitus
- Being tested
- Artificial Pancreas
- Keywords
- diabetes, type 1 diabetes, diabetes mellitus, pediatrics, diabetes camp
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial PancreasDevice
The system is composed of 3 main components:
- Insulin infusion pump to infuse insulin. The pump model used in the study is t:slim, Tandem Diabetes Care.
- Continuous glucose monitor (CGM) to continuously measure glucose levels in the interstitial fluid. Glucose levels will be measured by Dexcom G5® CGM.
- MAP application (iMAP) that computes insulin infusion based on the glucose values. The application also alarms the user when glucose sensor values are approaching the hypoglycemic or hyperglycemic range. The iMAP runs on an android smartphone.
Every 10 minutes, iMAP retrieves the glucose values from the Dexcom G5 CGM via Bluetooth. The application computes an optimal insulin infusion rate based on i) the current glucose reading, ii) the glucose trend (i.e. how quickly the glucose level is rising or falling) and iii) the open-loop basal rates (study parameters). The insulin recommendations are then sent wirelessly via Bluetooth to the insulin pump.
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop therapy | Experimental | Participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be determined by the camp's physicians. The research staff will update the pump's settings to reflect the physician's recommendations at the beginning of the closed-loop therapy, and each time the physicians update the study parameters. The closed-loop therapy will last 2 days (48 hours). Receives: Device: Artificial Pancreas |
| Closed-loop therapy with learning module | Experimental | participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be computed by the learning algorithm and updated daily. The learning algorithm runs on a computer of the research staff members and requires patient data to calculate the optimal basal rates and ICR. Each day, the research staff members will upload patient data onto the computer, run the leaning algorithm, and update the pump parameters to reflect the recommendations computed by the learning algorithm. The closed-loop therapy with the learning module will last 8 days (192 hours). Receives: Device: Artificial Pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of sensor glucose levels spent in target range
Target range defined to be between 3.9 mmol/L and 10.0 mmol/L
Measured: 10-24hour periods
Secondary outcomes (7)
Percentage of time of sensor glucose levels spent
- between 3.9 and 7.8 mmol/L;
- between 3.9 and 10 mmol/L;
- below 3.9 mmol/L;
- below 3.3 mmol/L;
- below 2.8 mmol/L;
- above 7.8 mmol/L;
- above 10 mmol/L;
- above 13.9 mmol/L;
- above 16.7 mmol/L.
Measured: 10-24hour periods
Percentage of overnight time (23:00-7:00) of sensor glucose levels
- between 3.9 and 7.8 mmol/L;
- between 3.9 and 10 mmol/L;
- below 3.9 mmol/L;
- below 3.3 mmol/L;
- below 2.8 mmol/L;
- above 7.8 mmol/L;
- above 10 mmol/L;
- above 13.9 mmol/L;
- above 16.7 mmol/L.
Measured: 10-24hour periods
Percentage of daytime (7:00-23:00) of sensor glucose levels
Percentage of daytime (7:00-23:00) of sensor glucose levels
- between 3.9 and 7.8 mmol/L;
- between 3.9 and 10 mmol/L;
- below 3.9 mmol/L;
- below 3.3 mmol/L;
- below 2.8 mmol/L;
- above 7.8 mmol/L;
- above 10 mmol/L;
- above 13.9 mmol/L;
- above 16.7 mmol/L.
Measured: 10-24hour periods
Standard deviation of glucose levels as a measure of glucose variability.
Measured: 10-24hour periods
Total insulin delivery.
Measured: 10-24hour periods
Mean sensor glucose level during: a. the overall study period; b. the daytime period; c. overnight period.
Measured: 10-24hour periods
Number of participants experiencing hypoglycemia requiring oral treatment during:
Measured: 10-24hour periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start2 Jul 2018
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is an open-label, randomized, two-way, cross-over study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581968
- Sponsor's protocol ID
- 2018-4269
- Status last verified
- Nov 2018
- First submitted
- 27 Jun 2018
- Last updated
- 29 Nov 2018
- Results posted
- 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 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Two-Way, Cross-Over Study to Compare the Efficacy of Closed-Loop Strategy With and Without a Learning Component in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp
- ClinicalTrials.gov ID
- NCT03581968
- Acronym / sponsor ID
- 2018-4269
- Conditions
- Diabetes, Type 1 Diabetes Mellitus
- Keywords
- diabetes, type 1 diabetes, diabetes mellitus, pediatrics, diabetes camp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 10 Jul 2018 (actual)
- 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.
Our lab has developed an artificial pancreas system called the McGill Artificial Pancreas (MAP) for automating insulin delivery. Using patient's basal-bolus parameters (basal rates and ICRs), the artificial pancreas involves a control algorithm that modulates insulin infusion based on the sensor readings and meal information. However, because basal-bolus parameters are difficult to optimize, proper glycemic control is not always achieved. Therefore, we have developed a learning algorithm that estimates optimal basal-bolus parameters using data over several days. The algorithm examines daily glucose, insulin, and meal data to make changes in patients' basal rates and ICRs.
The objective of this project is to test our artificial pancreas system with and without the learning algorithm using a randomized crossover design in between 31 and 67 children and adolescents at camp Carowanis. We hypothesize that adding a learning algorithm to the artificial pancreas will improve the performance of our artificial pancreas system by increasing the time spent in target glucose range (4mmol/L - 10mmol/L) compared with the artificial pancreas system alone.
Detailed description
This is an open-label, randomized, two-way, cross-over study to compare the glucose control between closed-loop strategy with and without a learning module. Children and adolescent type 1 diabetes patients at Camp Carowanis will be enrolled in the study, where they will undergo two randomly ordered interventions:
- Closed-loop therapy: participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be determined by the camp's physicians on day 1 of camp. The research staff will update the pump's settings to reflect the physician's recommendations at the beginning of the closed-loop therapy, and each time the physicians update the study parameters. Camp physicians will review participants' sensor and insulin data daily, and if necessary, adjust participant basal rates and ICRs. The research staff members will likewise adjust the pump's basal rates and ICR settings as per physician's recommendations. The closed-loop therapy will last 2 days (48 hours).
- Closed-loop therapy with learning module: participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be computed by the learning algorithm and updated daily. The learning algorithm runs on a computer of the research staff members and requires patient data to calculate the optimal basal rates and ICR. Each morning, the research staff members will upload patient data onto the computer, run the leaning algorithm, and update the pump parameters to reflect the recommendations computed by the learning algorithm. Camp physicians will be to review the algorithm's recommendations before they are entered into the patient's pump. The closed-loop therapy with the learning module will last 8 days (192 hours).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is an open-label, randomized, two-way, cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Closed-loop therapy | Experimental | Device: Artificial PancreasParticipants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be determined by the camp's physicians. The research staff will update the pump's settings to reflect the physician's recommendations at the beginning of the closed-loop therapy, and each time the physicians update the study parameters. The closed-loop therapy will last 2 days (48 hours). |
| Closed-loop therapy with learning module | Experimental | Device: Artificial Pancreasparticipants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be computed by the learning algorithm and updated daily. The learning algorithm runs on a computer of the research staff members and requires patient data to calculate the optimal basal rates and ICR. Each day, the research staff members will upload patient data onto the computer, run the leaning algorithm, and update the pump parameters to reflect the recommendations computed by the learning algorithm. The closed-loop therapy with the learning module will last 8 days (192 hours). |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Males and females between 8 and 21 years old.
- 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 ≤ 11%.
Key exclusion criteria (3 listed)
- Participants who cannot or are unwilling to use NovoRapid (Aspart) insulin or Humalog (Lispro) insulin for the duration of the study.
- 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 the study protocol or with team's recommendations (e.g. not willing to use trial pump, etc.).
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 |
|---|---|---|
| Artificial PancreasThe system is composed of 3 main components: 1. Insulin infusion pump to infuse insulin. The pump model used in the study is t:slim, Tandem Diabetes Care. 2. Continuous glucose monitor (CGM) to continuously measure glucose levels in the interstitial fluid. Glucose levels will be measured by Dexcom G5® CGM. 3. MAP application (iMAP) that computes insulin infusion based on the glucose values. The application also alarms the user when glucose sensor values are approaching the hypoglycemic or hyperglycemic range. The iMAP runs on an android smartphone. Every 10 minutes, iMAP retrieves the glucose values from the Dexcom G5 CGM via Bluetooth. The application computes an optimal insulin infusion rate based on i) the current glucose reading, ii) the glucose trend (i.e. how quickly the glucose level is rising or falling) and iii) the open-loop basal rates (study parameters). The insulin recommendations are then sent wirelessly via Bluetooth to the insulin pump. | Device | Closed-loop therapy, Closed-loop therapy with learning module |
Primary outcome
Percentage of time of sensor glucose levels spent in target range
Time frame: 10-24hour periods
Target range defined to be between 3.9 mmol/L and 10.0 mmol/L
7 secondary outcomes
Percentage of time of sensor glucose levels spent
Time frame: 10-24hour periods
Percentage of overnight time (23:00-7:00) of sensor glucose levels
Time frame: 10-24hour periods
Percentage of daytime (7:00-23:00) of sensor glucose levels
Time frame: 10-24hour periods
Standard deviation of glucose levels as a measure of glucose variability.
Time frame: 10-24hour periods
Total insulin delivery.
Time frame: 10-24hour periods
Mean sensor glucose level during: a. the overall study period; b. the daytime period; c. overnight period.
Time frame: 10-24hour periods
Number of participants experiencing hypoglycemia requiring oral treatment during:
Time frame: 10-24hour periods
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 29 Nov 2018.
- 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 Artificial Pancreas in people with Diabetes and Type 1 Diabetes Mellitus, 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 3 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 29 Nov 2018. 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?
Percentage of time of sensor glucose levels spent in target range (time frame: 10-24hour periods). 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 29 Nov 2018.