Type 1 DiabetesPhase 2NCT02488616
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes
A Phase 2 study testing 5-day intervention with single-hormone closed-loop strategy, 5-day intervention with sensor-augmented pump therapy and Insulin pump 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?
- 5-day intervention with single-hormone closed-loop strategy, 5-day intervention with sensor-augmented pump therapy and Insulin pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2018to Nov 2018
- 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 ≤ 10%.
- Live in the area of Montreal.
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.
- Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
- Pregnancy (ongoing or current attempt to become pregnant).
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
Show all 9Show fewer
- Known or suspected allergy to the trial products
- 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).
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, Two-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 5 Days in Free-living Outpatient 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.
The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings for 5 consecutive days in adults with type 1 diabetes.
The investigators hypothesized that single-hormone closed-loop strategy will increase the time spent in the target range compared to sensor-augmented pump therapy.
- Conditions
- Type 1 Diabetes
- Being tested
- 5-day intervention with single-hormone closed-loop strategy, 5-day intervention with sensor-augmented pump therapy, Insulin pump, Continuous glucose monitoring system, Insulin
- Keywords
- Closed-loop system, Artificial pancreas, Type 1 diabetes, Hypoglycemia, Insulin
- 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.
5-day intervention with single-hormone closed-loop strategyOther
A sensor will be inserted on the day prior to the first day of the intervention by the participants. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given.
Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 5 days.
5-day intervention with sensor-augmented pump therapyOther
A sensor will be inserted on the day prior to the first day of the intervention by the participants. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 5 days.
Participants will have been previously shown how to use the study insulin pump.
Insulin pumpDevice
MiniMed® Paradigm® Veo™, Medtronic
Continuous glucose monitoring systemDevice
Enlite sensor®, Medtronic
InsulinDrug
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)
| Study group | Role | What they receive |
|---|---|---|
| Sensor-augmented pump therapy | Active comparator | Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours. Receives: Other: 5-day intervention with sensor-augmented pump therapy; Device: Insulin pump; Device: Continuous glucose monitoring system; Drug: Insulin |
| Single-hormone closed-loop strategy | Active comparator | Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump. Receives: Other: 5-day intervention with single-hormone closed-loop strategy; Device: Insulin pump; Device: Continuous glucose monitoring system; Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L
Measured: 120 hours
Secondary outcomes (41)
Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Measured: 120 hours
Percentage of time of glucose levels spent below 3.9 mmol/L
Measured: 120 hours
Percentage of time of glucose levels spent below 3.3 mmol/L
Measured: 120 hours
Percentage of time of glucose levels spent below 2.8 mmol/L
Measured: 120 hours
Percentage of time of glucose levels spent above 10 mmol/L
Measured: 120 hours
Percentage of time of glucose levels spent above 13.9 mmol/L
Measured: 120 hours
Percentage of time of glucose levels spent above 16.7 mmol/L
Measured: 120 hours
Percentage of time of overnight glucose levels spent below 3.9 mmol/L
Measured: 35 hours
Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L
Measured: 35 hours
Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L
Measured: 35 hours
Percentage of time of overnight glucose levels spent below 3.3 mmol/L
Measured: 35 hours
Percentage of time of overnight glucose levels spent below 2.8 mmol/L
Measured: 35 hours
Percentage of time of overnight glucose levels spent above 10 mmol/L
Measured: 35 hours
Percentage of time of overnight glucose levels spent above 13.9 mmol/L
Measured: 35 hours
Percentage of time of overnight glucose levels spent above 16.7 mmol/L
Measured: 35 hours
Area under the curve of glucose levels below 3.9 mmol/L
Measured: 120 hours
Area under the curve of glucose levels below 3.3 mmol/L
Measured: 120 hours
Area under the curve of glucose levels below 2.8 mmol/L
Measured: 120 hours
Area under the curve of glucose levels above 10 mmol/L
Measured: 120 hours
Area under the curve of glucose levels above 13.9 mmol/L
Measured: 120 hours
Area under the curve of glucose levels above 16.7 mmol/L
Measured: 120 hours
Area under the curve of overnight glucose levels below 3.9 mmol/L
Measured: 35 hours
Area under the curve of overnight glucose levels below 3.3 mmol/L
Measured: 35 hours
Area under the curve of overnight glucose levels below 2.8 mmol/L
Measured: 35 hours
Area under the curve of overnight glucose levels above 10 mmol/L
Measured: 35 hours
Area under the curve of overnight glucose levels above 13.9 mmol/L
Measured: 35 hours
Area under the curve of overnight glucose levels above 16.7 mmol/L
Measured: 35 hours
Mean glucose levels
Measured: 120 hours
Standard deviation of glucose levels
Measured: 120 hours
Standard deviation of insulin delivery
Measured: 120 hours
Coefficient of variance of glucose levels
Measured: 120 hours
Coefficient of variance of insulin delivery
Measured: 120 hours
Between-day variability in glucose levels
Measured: 120 hours
Between-day variability in insulin delivery
Measured: 120 hours
Total insulin delivery
Measured: 120 hours
Percentage of time of closed-loop operation
Measured: 120 hours
Percentage of time of glucose sensor availability
Measured: 120 hours
Time between failures
Total hours of closed-loop operation over number of failures
Measured: 120 hours
Number of hypoglycemic events less than 3.1 mmol/L
Measured: 120 hours
Number of nights with hypoglycemic events less than 3.1 mmol/L
Measured: 35 hours
Number of days with hypoglycemic events less than 3.1 mmol/L
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startMar 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Why it stopped: Medtronic support terminated
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
- 0 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
- NCT02488616
- Sponsor's protocol ID
- CLASS-11
- Status last verified
- Jan 2018
- First submitted
- 26 Jun 2015
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 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 Assess the Efficacy of Single-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 5 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02488616
- Acronym / sponsor ID
- CLASS-11
- Conditions
- Type 1 Diabetes
- Keywords
- Closed-loop system, Artificial pancreas, Type 1 diabetes, Hypoglycemia, Insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Medtronic support terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 2 Jul 2015 (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.
The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings for 5 consecutive days in adults with type 1 diabetes.
The investigators hypothesized that single-hormone closed-loop strategy will increase the time spent in the target range compared to sensor-augmented pump therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensor-augmented pump therapy | Active comparator | Other: 5-day intervention with sensor-augmented pump therapy, Device: Insulin pump, Device: Continuous glucose monitoring system, Drug: InsulinParticipants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours. |
| Single-hormone closed-loop strategy | Active comparator | Other: 5-day intervention with single-hormone closed-loop strategy, Device: Insulin pump, Device: Continuous glucose monitoring system, Drug: InsulinVariable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 ≤ 10%.
- Live in the area of Montreal.
Key exclusion criteria (9 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.
- Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
- Pregnancy (ongoing or current attempt to become pregnant).
- 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 |
|---|---|---|
| 5-day intervention with single-hormone closed-loop strategyA sensor will be inserted on the day prior to the first day of the intervention by the participants. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 5 days. | Other | Single-hormone closed-loop strategy |
| 5-day intervention with sensor-augmented pump therapyA sensor will be inserted on the day prior to the first day of the intervention by the participants. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 5 days. Participants will have been previously shown how to use the study insulin pump. | Other | Sensor-augmented pump therapy |
| Insulin pumpMiniMed® Paradigm® Veo™, Medtronic | Device | Sensor-augmented pump therapy, Single-hormone closed-loop strategy |
| Continuous glucose monitoring systemEnlite sensor®, Medtronic | Device | Sensor-augmented pump therapy, Single-hormone closed-loop strategy |
| InsulinParticipant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra) | Drug | Sensor-augmented pump therapy, Single-hormone closed-loop strategy |
Primary outcome
Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L
Time frame: 120 hours
41 secondary outcomes
Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent below 3.9 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent below 3.3 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent below 2.8 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent above 10 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent above 13.9 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent above 16.7 mmol/L
Time frame: 120 hours
Percentage of time of overnight glucose levels spent below 3.9 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent below 3.3 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent below 2.8 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent above 10 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent above 13.9 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent above 16.7 mmol/L
Time frame: 35 hours
Area under the curve of glucose levels below 3.9 mmol/L
Time frame: 120 hours
Area under the curve of glucose levels below 3.3 mmol/L
Time frame: 120 hours
Area under the curve of glucose levels below 2.8 mmol/L
Time frame: 120 hours
Area under the curve of glucose levels above 10 mmol/L
Time frame: 120 hours
Area under the curve of glucose levels above 13.9 mmol/L
Time frame: 120 hours
Area under the curve of glucose levels above 16.7 mmol/L
Time frame: 120 hours
Area under the curve of overnight glucose levels below 3.9 mmol/L
Time frame: 35 hours
Area under the curve of overnight glucose levels below 3.3 mmol/L
Time frame: 35 hours
Area under the curve of overnight glucose levels below 2.8 mmol/L
Time frame: 35 hours
Area under the curve of overnight glucose levels above 10 mmol/L
Time frame: 35 hours
Area under the curve of overnight glucose levels above 13.9 mmol/L
Time frame: 35 hours
Area under the curve of overnight glucose levels above 16.7 mmol/L
Time frame: 35 hours
Mean glucose levels
Time frame: 120 hours
Standard deviation of glucose levels
Time frame: 120 hours
Standard deviation of insulin delivery
Time frame: 120 hours
Coefficient of variance of glucose levels
Time frame: 120 hours
Coefficient of variance of insulin delivery
Time frame: 120 hours
Between-day variability in glucose levels
Time frame: 120 hours
Between-day variability in insulin delivery
Time frame: 120 hours
Total insulin delivery
Time frame: 120 hours
Percentage of time of closed-loop operation
Time frame: 120 hours
Percentage of time of glucose sensor availability
Time frame: 120 hours
Time between failures
Time frame: 120 hours
Number of hypoglycemic events less than 3.1 mmol/L
Time frame: 120 hours
Number of nights with hypoglycemic events less than 3.1 mmol/L
Time frame: 35 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 5-day intervention with single-hormone closed-loop strategy, 5-day intervention with sensor-augmented pump therapy and Insulin pump 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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 31 Jan 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.
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 was withdrawn before enrolling participants, so there are no results.
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 spent between 3.9 and 10.0 mmol/L (time frame: 120 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 31 Jan 2018.