Type 1 DiabetesPhase 1/2CLASS-01NCT01297946
Closed-loop Control of Glucose Levels in the Context of Exercise in Adults With Type-1 Diabetes
A Phase 1/2 study testing Conventional continuous subcutaneous insulin infusion therapy and Dual-hormone closed-loop in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Conventional continuous subcutaneous insulin infusion therapy and Dual-hormone closed-loop
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes for at least one year.
- On insulin pump therapy for at least 3 months.
- HbA1c ≤ 10%.
Who cannot join
- Clinically significant nephropathy, neuropathy or retinopathy.
- 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 (by any route of administration except low dose stable inhaled).
Show all 10Show fewer
- 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 snack, not willing to change pump parameters, etc).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de Recherches Cliniques de Montréal (IRCM)
Montreal, Quebec, H2W 1R7
About this study
Official title: An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Dual-hormone Closed-loop Strategy as Compared to Conventional CSII Therapy in Regulating Glucose Levels in Adults With Type-1 Diabetes in the Context of Exercise
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(s) infusion rate is altered based on a computer-generated recommendation that relies on continuous glucose sensor readings. In this study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII) therapy in regulating glucose levels during an evening exercise and on a night following an exercise in adults with type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- Conventional continuous subcutaneous insulin infusion therapy, Dual-hormone closed-loop
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional continuous subcutaneous insulin infusion therapyDevice
Dual-hormone closed-loopDevice
| Study group | Role | What they receive |
|---|---|---|
| Open-loop | Placebo comparator | Conventional continuous subcutaneous insulin infusion (CSII) therapy Receives: Device: Conventional continuous subcutaneous insulin infusion therapy |
| Dual-hormone closed-loop | Experimental | Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. The infusion rates are based on continuous glucose sensor reading and a control algorithm. Receives: Device: Dual-hormone closed-loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of plasma glucose concentrations spent in target range (4.0-10.0 mmol/l from 4:00p.m.-11:00p.m. and 4.0-8.0 mmol/l from 11:00p.m.-7:00a.m.)
Measured: 4 p.m. - 7 a.m.
Secondary outcomes (17)
Percentage of time of plasma glucose concentrations spent in the low range (< 4.0 mmol/l).
Measured: 4 p.m. - 7 a.m.
Percentage of time of plasma glucose concentrations spent in the high range (>10.0 mmol/l from 4:00p.m.-11:00 p.m. and >8.0 mmol/l from 11:00 p.m.-7:00 a.m.).
Measured: 4 p.m. - 7 a.m
Percentage of overnight time of plasma glucose concentrations spent in target range (4.0 - 8.0 mmol/l).
Measured: 11 p.m. - 7 a.m.
Percentage of overnight time of plasma glucose concentrations spent in the low range ( < 4.0 mmol/l).
Measured: 11 p.m. - 7 a.m.
Percentage of overnight time of plasma glucose concentrations spent in the high range (above 8 mmol/l).
Measured: 11 p.m. - 7 a.m.
Total insulin delivery.
Measured: 4 p.m. - 7 a.m.
Total overnight insulin delivery (11 p.m. - 7 a.m.).
Measured: 11 p.m. - 7 a.m.
Standard deviation and/or MAGE (Mean Amplitude of Glycemic Excursions) index of plasma glucose concentrations as measures of glucose variability.
Measured: 4 p.m. - 7 a.m.
Number of subjects with at least one plasma glucose measurement less than 3.9 mmol/l.
Measured: 4 p.m. - 7 a.m.
Number of subjects with at least one overnight plasma glucose measurement less than 3.9 mmol/l.
Measured: 11 p.m. - 7 a.m
Number of subjects with at least one exercise-induced plasma glucose measurement less than 3.9 mmol/l.
Measured: 5:50 p.m. - 7:20 p.m
Number of subjects with as at least one plasma glucose measurement below 3.3 mmol/l.
Measured: 4 p.m. - 7 a.m.
Number of subjects with at least one overnight plasma glucose measurement below 3.3 mmol/l.
Measured: 11 p.m. - 7 a.m
Number of subjects with at least one exercise-induced plasma glucose measurement below 3.3 mmol/l.
Measured: 5:50 p.m. - 7:20 p.m
Number of subjects with as at least one plasma glucose measurement below 3.0 mmol/l.
Measured: 4 p.m. - 7 a.m.
Number of subjects with at least one overnight plasma glucose measurement below 3.0 mmol/l.
Measured: 11 p.m. - 7 a.m
Number of subjects with at least one exercise-induced plasma glucose measurement below 3.0 mmol/l.
Measured: 5:50 p.m. - 7:20 p.m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 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, Diabetes Québec, Medtronic Minimed
- Investigators
- Rémi Rabasa-Lhoret, M.D., Ph.D., Principal investigator, Institut de Recherches Cliniques de Montréal (IRCM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297946
- Sponsor's protocol ID
- CLASS-01
- Acronym
- CLASS-01
- Status last verified
- Jan 2012
- First submitted
- 15 Feb 2011
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Heyland DK, Heyland R, Bailey A, Howard M. A novel decision aid to help plan for serious illness: a multisite randomized trial. CMAJ Open. 2020 Apr 28;8(2):E289-E296. doi: 10.9778/cmajo.20190179. Print 2020 Apr-Jun.
PubMed 32345707Haidar A, Legault L, Dallaire M, Alkhateeb A, Coriati A, Messier V, Cheng P, Millette M, Boulet B, Rabasa-Lhoret R. Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial. CMAJ. 2013 Mar 5;185(4):297-305. doi: 10.1503/cmaj.121265. Epub 2013 Jan 28.
PubMed 23359039
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. 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 Assess the Efficacy of Dual-hormone Closed-loop Strategy as Compared to Conventional CSII Therapy in Regulating Glucose Levels in Adults With Type-1 Diabetes in the Context of Exercise
- ClinicalTrials.gov ID
- NCT01297946
- Acronym / sponsor ID
- CLASS-01 / CLASS-01
- Conditions
- Type 1 Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- McGill University, Montreal Children's Hospital of the MUHC, Diabetes Québec, Medtronic Minimed
- First posted
- 17 Feb 2011 (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.
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(s) infusion rate is altered based on a computer-generated recommendation that relies on continuous glucose sensor readings. In this study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII) therapy in regulating glucose levels during an evening exercise and on a night following an exercise in adults with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open-loop | Placebo comparator | Device: Conventional continuous subcutaneous insulin infusion therapyConventional continuous subcutaneous insulin infusion (CSII) therapy |
| Dual-hormone closed-loop | Experimental | Device: Dual-hormone closed-loopVariable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. The infusion rates are based on continuous glucose sensor reading and a control algorithm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of type 1 diabetes for at least one year.
- On insulin pump therapy for at least 3 months.
- HbA1c ≤ 10%.
Key exclusion criteria (10 listed)
- Clinically significant nephropathy, neuropathy or retinopathy.
- 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 |
|---|---|---|
| Conventional continuous subcutaneous insulin infusion therapy | Device | Open-loop |
| Dual-hormone closed-loop | Device | Dual-hormone closed-loop |
Primary outcome
Percentage of time of plasma glucose concentrations spent in target range (4.0-10.0 mmol/l from 4:00p.m.-11:00p.m. and 4.0-8.0 mmol/l from 11:00p.m.-7:00a.m.)
Time frame: 4 p.m. - 7 a.m.
17 secondary outcomes
Percentage of time of plasma glucose concentrations spent in the low range (< 4.0 mmol/l).
Time frame: 4 p.m. - 7 a.m.
Percentage of time of plasma glucose concentrations spent in the high range (>10.0 mmol/l from 4:00p.m.-11:00 p.m. and >8.0 mmol/l from 11:00 p.m.-7:00 a.m.).
Time frame: 4 p.m. - 7 a.m
Percentage of overnight time of plasma glucose concentrations spent in target range (4.0 - 8.0 mmol/l).
Time frame: 11 p.m. - 7 a.m.
Percentage of overnight time of plasma glucose concentrations spent in the low range ( < 4.0 mmol/l).
Time frame: 11 p.m. - 7 a.m.
Percentage of overnight time of plasma glucose concentrations spent in the high range (above 8 mmol/l).
Time frame: 11 p.m. - 7 a.m.
Total insulin delivery.
Time frame: 4 p.m. - 7 a.m.
Total overnight insulin delivery (11 p.m. - 7 a.m.).
Time frame: 11 p.m. - 7 a.m.
Standard deviation and/or MAGE (Mean Amplitude of Glycemic Excursions) index of plasma glucose concentrations as measures of glucose variability.
Time frame: 4 p.m. - 7 a.m.
Number of subjects with at least one plasma glucose measurement less than 3.9 mmol/l.
Time frame: 4 p.m. - 7 a.m.
Number of subjects with at least one overnight plasma glucose measurement less than 3.9 mmol/l.
Time frame: 11 p.m. - 7 a.m
Number of subjects with at least one exercise-induced plasma glucose measurement less than 3.9 mmol/l.
Time frame: 5:50 p.m. - 7:20 p.m
Number of subjects with as at least one plasma glucose measurement below 3.3 mmol/l.
Time frame: 4 p.m. - 7 a.m.
Number of subjects with at least one overnight plasma glucose measurement below 3.3 mmol/l.
Time frame: 11 p.m. - 7 a.m
Number of subjects with at least one exercise-induced plasma glucose measurement below 3.3 mmol/l.
Time frame: 5:50 p.m. - 7:20 p.m
Number of subjects with as at least one plasma glucose measurement below 3.0 mmol/l.
Time frame: 4 p.m. - 7 a.m.
Number of subjects with at least one overnight plasma glucose measurement below 3.0 mmol/l.
Time frame: 11 p.m. - 7 a.m
Number of subjects with at least one exercise-induced plasma glucose measurement below 3.0 mmol/l.
Time frame: 5:50 p.m. - 7:20 p.m
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 23 Apr 2012.
- Derived from this study: PubMed 32345707Heyland DK, Heyland R, Bailey A, Howard M. A novel decision aid to help plan for serious illness: a multisite randomized trial. CMAJ Open. 2020 Apr 28;8(2):E289-E296. doi: 10.9778/cmajo.20190179. Print 2020 Apr-Jun.
- Derived from this study: PubMed 23359039Haidar A, Legault L, Dallaire M, Alkhateeb A, Coriati A, Messier V, Cheng P, Millette M, Boulet B, Rabasa-Lhoret R. Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial. CMAJ. 2013 Mar 5;185(4):297-305. doi: 10.1503/cmaj.121265. Epub 2013 Jan 28.
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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, M.D., Ph.D. principal investigator
Institut de Recherches Cliniques de Montréal (IRCM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Conventional continuous subcutaneous insulin infusion therapy and Dual-hormone closed-loop 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 3 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 23 Apr 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 concentrations spent in target range (4.0-10.0 mmol/l from 4:00p.m.-11:00p.m. and 4.0-8.0 mmol/l from 11:00p.m.-7:00a.m.) (time frame: 4 p.m. - 7 a.m.). 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 NCT01297946, which also lists 2 linked publications.
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 23 Apr 2012.