Type 1 DiabetesPhase 2NCT01754337
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults and Adolescents With Type 1 Diabetes
A Phase 2 study testing Closed-loop system in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Closed-loop system
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Jun 2014
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females ≥ 12 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- The subject will have been on insulin pump therapy for at least 3 months.
- HbA1c ≤ 12%.
Who cannot join
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
- Pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose).
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- Known or suspected allergy to the trial products or meal contents.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
- 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.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
About this study
Official title: An Open-label, Randomized, Three-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Pump Therapy in Regulating Glucose Levels During 24 Hours in Adults and Adolescents With Type 1 Diabetes
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate glucose levels in a 24-hours in-patient study with standardized conditions in adults and adolescents with type 1 diabetes.
The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.
Read the detailed description
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
We aim to conduct the 1st randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. We aim to compare the three interventions for 24 hours in adults and adolescents with type 1 diabetes. Each 24 hours will include a 60-min exercise session, three meals characterizing a full day, activities that mimick real-life conditions and an overnight stay. This study will also allow for multiple comparisons and evaluating the benefits of each component separately (i.e. the benefits of merely closing the loop with insulin alone vs. adding glucagon to the closed-loop strategy).
- Conditions
- Type 1 Diabetes
- Being tested
- Closed-loop system
- Keywords
- Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop system, Artificial pancreas
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop systemOther
Patients will be admitted at the research clinical facility at 7:00. At 8:00, a mixed meal will be served. At 9:00, patients will be asked to perform two 30-min standardized activities. At 12:00, a mixed meal will be served. At 13:00, patients will be asked to perform two 30-min activities. At 17:00, a mixed meal will be served. At 19:30, patients will perform 60 minutes of aerobic treadmill exercise at an intensity of 60% VO2max. A bedtime snack of 20g carbohydrate will be given at 21:00. Patients will be discharged at 8:00 the next morning
| Study group | Role | What they receive |
|---|---|---|
| Single-hormone closed-loop system | Active comparator | In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels. Receives: Other: Closed-loop system |
| Dual-hormone closed-loop system | Active comparator | In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Receives: Other: Closed-loop system |
| Insulin pump therapy | Active comparator | Patient's conventional treatment will be implemented. Receives: Other: Closed-loop system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of plasma glucose levels spent in target range.
Two-hour postprandial target range is between 4.0 and 10.0 mmol/l. Otherwise, target range is defined to be between 4.0 and 8.0 mmol/l.
Measured: 24 hours
Secondary outcomes (14)
Percentage of time of plasma glucose levels spent in the low range
Low range is defined to be a. below 4 mmol/L; b. below 3.5 mmol/L; c. below 3.3 mmol/L.
Measured: 24 hours
Percentage of overnight time of plasma glucose levels spent in the low range
Low range is defined to be a. < 4 mmol/L; b. < 3.5 mmol/L; c. < 3.3 mmol/L.
Measured: 9 hours
Standard deviation of glucose levels
Measure of glucose variability
Measured: 24 hours
Total insulin delivery
Measured: 24 hours
Mean plasma glucose level
Measured: 24 hours
Mean plasma glucose level
Measured: 9 hours
Mean plasma insulin concentration
Measured: 24 hours
Mean plasma glucagon concentration
Measured: 24 hours
Number of subjects experiencing hypoglycemia requiring oral treatment
Number of subjects experiencing hypoglycemia requiring oral treatment during a. the overall study period; b. the exercise; c. the night.
Measured: 24 hours
Percentage of time of plasma glucose levels spent between 4.0 and 10.0 mmol/L
Measured: 24 hours
Percentage of overnight time of plasma glucose levels spent between 4.0 and 8.0 mmol/L
Measured: 9 hours
Percentage of overnight time of plasma glucose levels spent between 4.0 and 10.0 mmol/L
Measured: 9 hours
Percentage of time of plasma glucose levels spent in the high range
High range is defined to be above a. 8.0 mmol/L; b. 10.0 mmol/L
Measured: 24 hours
Percentage of overnight time of plasma glucose levels spent in the high range
High range is defined to be above a. 8.0 mmol/L; b. 10.0 mmol/L.
Measured: 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Montreal Children's Hospital of the MUHC
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Rémi Rabasa-Lhoret, MD, PhD, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754337
- Sponsor's protocol ID
- CLASS-03
- Status last verified
- Jul 2014
- First submitted
- 13 Dec 2012
- Last updated
- 4 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Haidar A, Legault L, Messier V, Mitre TM, Leroux C, Rabasa-Lhoret R. Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes: an open-label randomised controlled crossover trial. Lancet Diabetes Endocrinol. 2015 Jan;3(1):17-26. doi: 10.1016/S2213-8587(14)70226-8. Epub 2014 Nov 27.
PubMed 25434967
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Three-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Pump Therapy in Regulating Glucose Levels During 24 Hours in Adults and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01754337
- Acronym / sponsor ID
- CLASS-03
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop system, Artificial pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- McGill University, Montreal Children's Hospital of the MUHC
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Dec 2012 (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.
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate glucose levels in a 24-hours in-patient study with standardized conditions in adults and adolescents with type 1 diabetes.
The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.
Detailed description
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
We aim to conduct the 1st randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. We aim to compare the three interventions for 24 hours in adults and adolescents with type 1 diabetes. Each 24 hours will include a 60-min exercise session, three meals characterizing a full day, activities that mimick real-life conditions and an overnight stay. This study will also allow for multiple comparisons and evaluating the benefits of each component separately (i.e. the benefits of merely closing the loop with insulin alone vs. adding glucagon to the closed-loop strategy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single-hormone closed-loop system | Active comparator | Other: Closed-loop systemIn single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels. |
| Dual-hormone closed-loop system | Active comparator | Other: Closed-loop systemIn dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. |
| Insulin pump therapy | Active comparator | Other: Closed-loop systemPatient's conventional treatment will be implemented. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females ≥ 12 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- The subject will have been on insulin pump therapy for at least 3 months.
- HbA1c ≤ 12%.
Key exclusion criteria (10 listed)
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
- Pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
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 systemPatients will be admitted at the research clinical facility at 7:00. At 8:00, a mixed meal will be served. At 9:00, patients will be asked to perform two 30-min standardized activities. At 12:00, a mixed meal will be served. At 13:00, patients will be asked to perform two 30-min activities. At 17:00, a mixed meal will be served. At 19:30, patients will perform 60 minutes of aerobic treadmill exercise at an intensity of 60% VO2max. A bedtime snack of 20g carbohydrate will be given at 21:00. Patients will be discharged at 8:00 the next morning | Other | Dual-hormone closed-loop system, Insulin pump therapy, Single-hormone closed-loop system |
Primary outcome
Percentage of time of plasma glucose levels spent in target range.
Time frame: 24 hours
Two-hour postprandial target range is between 4.0 and 10.0 mmol/l. Otherwise, target range is defined to be between 4.0 and 8.0 mmol/l.
14 secondary outcomes
Percentage of time of plasma glucose levels spent in the low range
Time frame: 24 hours
Percentage of overnight time of plasma glucose levels spent in the low range
Time frame: 9 hours
Standard deviation of glucose levels
Time frame: 24 hours
Total insulin delivery
Time frame: 24 hours
Mean plasma glucose level
Time frame: 24 hours
Mean plasma glucose level
Time frame: 9 hours
Mean plasma insulin concentration
Time frame: 24 hours
Mean plasma glucagon concentration
Time frame: 24 hours
Number of subjects experiencing hypoglycemia requiring oral treatment
Time frame: 24 hours
Percentage of time of plasma glucose levels spent between 4.0 and 10.0 mmol/L
Time frame: 24 hours
Percentage of overnight time of plasma glucose levels spent between 4.0 and 8.0 mmol/L
Time frame: 9 hours
Percentage of overnight time of plasma glucose levels spent between 4.0 and 10.0 mmol/L
Time frame: 9 hours
Percentage of time of plasma glucose levels spent in the high range
Time frame: 24 hours
Percentage of overnight time of plasma glucose levels spent in the high range
Time frame: 9 hours
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 4 Jul 2014.
- Derived from this study: PubMed 25434967Haidar A, Legault L, Messier V, Mitre TM, Leroux C, Rabasa-Lhoret R. Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes: an open-label randomised controlled crossover trial. Lancet Diabetes Endocrinol. 2015 Jan;3(1):17-26. doi: 10.1016/S2213-8587(14)70226-8. Epub 2014 Nov 27.
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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, MD, PhD 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 Closed-loop system 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 4 inclusion and 10 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 4 Jul 2014. 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 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 plasma glucose levels spent in target range. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01754337, which also lists 1 linked publication.
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 4 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.