Type 1 DiabetesPhase 2NCT01966393
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 60 Hours in Adults With Type 1 Diabetes
A Phase 2 study testing 60-hours intervention 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 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- 60-hours intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Apr 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of 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.
- 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.
- History of pheochromocytoma or insulinoma (glucagon could induce an hormonal response of these tumors)
- Beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses)
- Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose)
- Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
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- Anticholinergic drug (risk of interaction)
- Pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
- Known or suspected allergy to the trial products or meal contents (gluten free menus will be available).
- 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. need for major revision of carbohydrate counting).
- 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).
- Treatments that could interfere with glucagon
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 Insulin Pump Therapy in Regulating Glucose Levels During 60 Hours in Free-living Conditions in Patients 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 strategy would regulate glucose levels through the infusion of two hormones: 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 conventional insulin pump therapy to regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes.
The investigators hypothesized that 1) Controlling glucose levels using single- or dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2) Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional pump therapy.
- Conditions
- Type 1 Diabetes
- Being tested
- 60-hours intervention
- Keywords
- Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop strategy, 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.
60-hours interventionOther
Interventions will be conducted at the research centre (RC) or at the patient's home based on the patient's preference. If the study takes place at the RC, patients will be admitted at 7:00. If the study takes place at the patient's home, a research team member will be at the patient's home at 7:00. Closed-loop strategy will start at 8:00 on day 1 and end at 20:00 on day 3. During the interventions conducted at the RC, patients will have access to entertainment activities such as movies, video games, board games, foosball, etc. During the interventions conducted at the patient's home, patients will do their usual activities. For interventions conducted at the RC, patients will freely choose their meals from a large choice of prepared frozen meals. For interventions conducted at the patient's home, patients will freely choose their meals. Participants will be encouraged to conduct their usual physical activities whether they conduct the study at the RC or at the patient's home.
| Study group | Role | What they receive |
|---|---|---|
| Dual-hormone closed-loop strategy | Active comparator | In dual-hormone closed-loop strategy, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels Receives: Other: 60-hours intervention |
| Single-hormone closed-loop strategy | Active comparator | In single-hormone closed-loop strategy, variable subcutaneous insulin infusion rate will be used to regulate glucose levels Receives: Other: 60-hours intervention |
| Conventional insulin pump therapy | Active comparator | In control visit, subjects will use conventional pump therapy to regulate glucose levels. Receives: Other: 60-hours intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in the hypoglycemic range.
Hypoglycemic range is defined to be between below 4 mmol/L
Measured: 60 hours
Secondary outcomes (12)
Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in target range.
Target range is defined to be between 4 and 10 mmol/L from 7:00 to 22:00 and between 4 and 8 mmol/L from 22:00 to 7:00.
Measured: 60 hours
Percentage of time of glucose levels spent below 3.5 mmol/L
Measured: 60 hours
Percentage of time of glucose levels spent below 3.3 mmol/L
Measured: 60 hours
Area under the curve of glucose values below 4.0 mmol/L
Measured: 60 hours
Area under the curve of glucose values below 3.5 mmol/L
Measured: 60 hours
Area under the curve of glucose values below 3.3 mmol/L
Measured: 60 hours
Percentage of time of glucose levels spent above 8.0 mmol/L
Measured: 60 hours
Percentage of time of glucose levels spent above 10.0 mmol/L
Measured: 60 hours
Mean value of glucose levels
Measured: 60 hours
Standard deviation of glucose levels
Measured: 60 hours
Total insulin delivery
Measured: 60 hours
Number of patients with at least one hypoglycemic event with or without symptoms below 3.0 mmol/L based on glucose sensor reading
Measured: 60 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- 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
- NCT01966393
- Sponsor's protocol ID
- CLASS-07
- Status last verified
- May 2015
- First submitted
- 17 Oct 2013
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. 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 Insulin Pump Therapy in Regulating Glucose Levels During 60 Hours in Free-living Conditions in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01966393
- Acronym / sponsor ID
- CLASS-07
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop strategy, Artificial pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Oct 2013 (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 strategy would regulate glucose levels through the infusion of two hormones: 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 conventional insulin pump therapy to regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes.
The investigators hypothesized that 1) Controlling glucose levels using single- or dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2) Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional pump therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dual-hormone closed-loop strategy | Active comparator | Other: 60-hours interventionIn dual-hormone closed-loop strategy, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels |
| Single-hormone closed-loop strategy | Active comparator | Other: 60-hours interventionIn single-hormone closed-loop strategy, variable subcutaneous insulin infusion rate will be used to regulate glucose levels |
| Conventional insulin pump therapy | Active comparator | Other: 60-hours interventionIn control visit, subjects will use conventional pump therapy to regulate glucose levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females ≥ 18 years of 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.
- HbA1c ≤ 12%.
Key exclusion criteria (15 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.
- History of pheochromocytoma or insulinoma (glucagon could induce an hormonal response of these tumors)
- Beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses)
- Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose)
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 |
|---|---|---|
| 60-hours interventionInterventions will be conducted at the research centre (RC) or at the patient's home based on the patient's preference. If the study takes place at the RC, patients will be admitted at 7:00. If the study takes place at the patient's home, a research team member will be at the patient's home at 7:00. Closed-loop strategy will start at 8:00 on day 1 and end at 20:00 on day 3. During the interventions conducted at the RC, patients will have access to entertainment activities such as movies, video games, board games, foosball, etc. During the interventions conducted at the patient's home, patients will do their usual activities. For interventions conducted at the RC, patients will freely choose their meals from a large choice of prepared frozen meals. For interventions conducted at the patient's home, patients will freely choose their meals. Participants will be encouraged to conduct their usual physical activities whether they conduct the study at the RC or at the patient's home. | Other | Conventional insulin pump therapy, Dual-hormone closed-loop strategy, Single-hormone closed-loop strategy |
Primary outcome
Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in the hypoglycemic range.
Time frame: 60 hours
Hypoglycemic range is defined to be between below 4 mmol/L
12 secondary outcomes
Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in target range.
Time frame: 60 hours
Percentage of time of glucose levels spent below 3.5 mmol/L
Time frame: 60 hours
Percentage of time of glucose levels spent below 3.3 mmol/L
Time frame: 60 hours
Area under the curve of glucose values below 4.0 mmol/L
Time frame: 60 hours
Area under the curve of glucose values below 3.5 mmol/L
Time frame: 60 hours
Area under the curve of glucose values below 3.3 mmol/L
Time frame: 60 hours
Percentage of time of glucose levels spent above 8.0 mmol/L
Time frame: 60 hours
Percentage of time of glucose levels spent above 10.0 mmol/L
Time frame: 60 hours
Mean value of glucose levels
Time frame: 60 hours
Standard deviation of glucose levels
Time frame: 60 hours
Total insulin delivery
Time frame: 60 hours
Number of patients with at least one hypoglycemic event with or without symptoms below 3.0 mmol/L based on glucose sensor reading
Time frame: 60 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 May 2015.
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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 60-hours intervention 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 15 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 May 2015. 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 glucose levels (as measured by continuous glucose sensor) spent in the hypoglycemic range. (time frame: 60 hours). 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 4 May 2015; AzTrials last refreshed its copy on 6 Nov 2026.