Type 1 DiabetesPhase 2NCT02846831
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes
A Phase 2 study testing 12-day intervention with sensor-augmented pump therapy, 12-day intervention with single-hormone closed-loop strategy and Insulin pump in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 2 sites 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?
- 12-day intervention with sensor-augmented pump therapy, 12-day intervention with single-hormone closed-loop strategy 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
- 36 participants
- Where
- 2 sitesCanada
- Study dates
- 24 Jan 2019to 27 Jan 2020
- 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
- Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
- Chronic use of acetaminophen. Acetaminophen may interfere with glucose sensor readings
- Pregnancy (ongoing or current attempt to become pregnant)
- Breastfeeding
Show all 14Show fewer
- No nearby party for assistance if needed
- Plans to go abroad or travel at more than 2 hours distance from Montreal during the trial period
- Severe hypoglycemic episode within two weeks of screening or during the run-in period
- Severe hyperglycemic episode requiring hospitalization in the last 3 months
- Current use of glucocorticoid medication (except low stable dose and inhaled steroids)
- 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
- Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
McGill University Health Centre
Montreal, Quebec, H4A 3J1
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 12 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 objective of this study is to compare the effectiveness of single-hormone closed-loop and sensor-augmented pump therapy in regulating day-and-night glucose levels in adults with T1D for 12 days in outpatient settings.
The investigators hypothesize that dual-hormone closed-loop will increase the percentage of time of glucose levels spent in the target range in adults compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy.
- Conditions
- Type 1 Diabetes
- Being tested
- 12-day intervention with sensor-augmented pump therapy, 12-day intervention with single-hormone closed-loop strategy, Insulin pump, Continuous glucose monitoring system, Insulin
- Keywords
- Type 1 diabetes, Artificial pancreas, Closed-loop system, 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.
12-day intervention with sensor-augmented pump therapyOther
A sensor will be inserted on the day before the start 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 12 days.
Participants will have been previously shown how to use the study insulin pump.
12-day intervention with single-hormone closed-loop strategyOther
A sensor will be inserted on the day before the start 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.
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 12 days.
Insulin pumpDevice
Tandem Diabetes Care
Continuous glucose monitoring systemDevice
Dexcom G5 Platinum
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: 12-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: 12-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 mmol/L.
Measured: 288 hours
Secondary outcomes (37)
Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Measured: 288 hours
Percentage of time of glucose levels spent below 3.9 mmol/L
Measured: 288 hours
Percentage of time of glucose levels spent below 3.3 mmol/L
Measured: 288 hours
Percentage of time of glucose levels spent below 2.8 mmol/L
Measured: 288 hours
Percentage of time of glucose levels spent above 10.0 mmol/L
Measured: 288 hours
Percentage of time of glucose levels spent above 13.9 mmol/L
Measured: 288 hours
Percentage of time of glucose levels spent above 16.7 mmol/L
Measured: 288 hours
Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L
The overnight period is between 00:00 and 06:00
Measured: 72 hours
Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L
The overnight period is between 00:00 and 06:00
Measured: 72 hours
Percentage of time of overnight glucose levels spent below 3.9 mmol/L
The overnight period is between 00:00 and 06:00
Measured: 72 hours
Percentage of time of overnight glucose levels spent below 3.3 mmol/L
The overnight period is between 00:00 and 06:00
Measured: 72 hours
Percentage of time of overnight glucose levels spent below 2.8 mmol/L
The overnight period is between 00:00 and 06:00
Measured: 72 hours
Percentage of time of overnight glucose levels spent above 10.0 mmol/L
The overnight period is between 00:00 and 06:00
Measured: 72 hours
Percentage of time of overnight glucose levels spent above 13.9 mmol/L
The overnight period is between 00:00 and 06:00
Measured: 72 hours
Percentage of time of overnight glucose levels spent above 16.7 mmol/L
The overnight period is between 00:00 and 06:00
Measured: 72 hours
Total number of hypoglycemic events below 3.1 mmol/L
Measured: 288 hours
Number of nights with hypoglycemic events below 3.1 mmol/L
Measured: 72 hours
Number of days with hypoglycemic events below 3.1 mmol/L
Measured: 126 hours
Mean glucose levels
Measured: 288 hours
Standard deviation of glucose levels
Measured: 288 hours
Time between failures due to glucose sensor unavailability
Measured: 288 hours
Coefficient of variation of glucose levels
Measured: 288 hours
Between-day variability in glucose levels
Measured: 288 hours
Total daily insulin dose
Measured: 24 hours
Standard deviation of insulin delivery
Measured: 288 hours
Coefficient of variation of insulin delivery
Measured: 288 hours
Between-day variability in insulin delivery
Measured: 288 hours
Total number of hours of glucose sensor availability
Measured: 288 hours
Percentage of time of glucose sensor availability
Measured: 288 hours
Time between failures due to pump connectivity
Measured: 288 hours
Percentage of time when patients switched back to insulin pump therapy
Measured: 288 hours
Number of hours when patients switched back to insulin pump therapy
Measured: 288 hours
Percentage of time when the closed-loop was automatically switched to insulin pump therapy
Measured: 288 hours
Number of hours when the closed-loop was automatically switched to insulin pump therapy
Measured: 288 hours
Number of days with at least one technical problem
Measured: 288 hours
Number of calls for technical issues related to the closed-loop system
Measured: 288 hours
Number of patients calling for technical issues related to the closed-loop system
Measured: 288 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start24 Jan 2019
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
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
- 36 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, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846831
- Sponsor's protocol ID
- CLASS-14
- Status last verified
- Jun 2020
- First submitted
- 25 Jul 2016
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Haidar A, Legault L, Raffray M, Gouchie-Provencher N, Jacobs PG, El-Fathi A, Rutkowski J, Messier V, Rabasa-Lhoret R. Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial. Diabetes Technol Ther. 2021 Mar;23(3):168-174. doi: 10.1089/dia.2020.0365. Epub 2020 Dec 31.
PubMed 33050728
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. 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 12 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02846831
- Acronym / sponsor ID
- CLASS-14
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Artificial pancreas, Closed-loop system, Hypoglycemia, Insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 27 Jul 2016 (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 objective of this study is to compare the effectiveness of single-hormone closed-loop and sensor-augmented pump therapy in regulating day-and-night glucose levels in adults with T1D for 12 days in outpatient settings.
The investigators hypothesize that dual-hormone closed-loop will increase the percentage of time of glucose levels spent in the target range in adults compared to single-hormone closed-loop, which in turn will be more effective than 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: 12-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: 12-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 (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 (14 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)
- Chronic use of acetaminophen. Acetaminophen may interfere with glucose sensor readings
- Pregnancy (ongoing or current attempt to become pregnant)
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 |
|---|---|---|
| 12-day intervention with sensor-augmented pump therapyA sensor will be inserted on the day before the start 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 12 days. Participants will have been previously shown how to use the study insulin pump. | Other | Sensor-augmented pump therapy |
| 12-day intervention with single-hormone closed-loop strategyA sensor will be inserted on the day before the start 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. 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 12 days. | Other | Single-hormone closed-loop strategy |
| Insulin pumpTandem Diabetes Care | Device | Sensor-augmented pump therapy, Single-hormone closed-loop strategy |
| Continuous glucose monitoring systemDexcom G5 Platinum | 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 mmol/L.
Time frame: 288 hours
37 secondary outcomes
Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Time frame: 288 hours
Percentage of time of glucose levels spent below 3.9 mmol/L
Time frame: 288 hours
Percentage of time of glucose levels spent below 3.3 mmol/L
Time frame: 288 hours
Percentage of time of glucose levels spent below 2.8 mmol/L
Time frame: 288 hours
Percentage of time of glucose levels spent above 10.0 mmol/L
Time frame: 288 hours
Percentage of time of glucose levels spent above 13.9 mmol/L
Time frame: 288 hours
Percentage of time of glucose levels spent above 16.7 mmol/L
Time frame: 288 hours
Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L
Time frame: 72 hours
Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L
Time frame: 72 hours
Percentage of time of overnight glucose levels spent below 3.9 mmol/L
Time frame: 72 hours
Percentage of time of overnight glucose levels spent below 3.3 mmol/L
Time frame: 72 hours
Percentage of time of overnight glucose levels spent below 2.8 mmol/L
Time frame: 72 hours
Percentage of time of overnight glucose levels spent above 10.0 mmol/L
Time frame: 72 hours
Percentage of time of overnight glucose levels spent above 13.9 mmol/L
Time frame: 72 hours
Percentage of time of overnight glucose levels spent above 16.7 mmol/L
Time frame: 72 hours
Total number of hypoglycemic events below 3.1 mmol/L
Time frame: 288 hours
Number of nights with hypoglycemic events below 3.1 mmol/L
Time frame: 72 hours
Number of days with hypoglycemic events below 3.1 mmol/L
Time frame: 126 hours
Mean glucose levels
Time frame: 288 hours
Standard deviation of glucose levels
Time frame: 288 hours
Time between failures due to glucose sensor unavailability
Time frame: 288 hours
Coefficient of variation of glucose levels
Time frame: 288 hours
Between-day variability in glucose levels
Time frame: 288 hours
Total daily insulin dose
Time frame: 24 hours
Standard deviation of insulin delivery
Time frame: 288 hours
Coefficient of variation of insulin delivery
Time frame: 288 hours
Between-day variability in insulin delivery
Time frame: 288 hours
Total number of hours of glucose sensor availability
Time frame: 288 hours
Percentage of time of glucose sensor availability
Time frame: 288 hours
Time between failures due to pump connectivity
Time frame: 288 hours
Percentage of time when patients switched back to insulin pump therapy
Time frame: 288 hours
Number of hours when patients switched back to insulin pump therapy
Time frame: 288 hours
Percentage of time when the closed-loop was automatically switched to insulin pump therapy
Time frame: 288 hours
Number of hours when the closed-loop was automatically switched to insulin pump therapy
Time frame: 288 hours
Number of days with at least one technical problem
Time frame: 288 hours
Number of calls for technical issues related to the closed-loop system
Time frame: 288 hours
Number of patients calling for technical issues related to the closed-loop system
Time frame: 288 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 11 Jun 2020.
- Derived from this study: PubMed 33050728Haidar A, Legault L, Raffray M, Gouchie-Provencher N, Jacobs PG, El-Fathi A, Rutkowski J, Messier V, Rabasa-Lhoret R. Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial. Diabetes Technol Ther. 2021 Mar;23(3):168-174. doi: 10.1089/dia.2020.0365. Epub 2020 Dec 31.
- Individual participant dataSharing planned: Undecided
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 principal investigator
Institut de Recherches Cliniques de Montreal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 12-day intervention with sensor-augmented pump therapy, 12-day intervention with single-hormone closed-loop strategy and Insulin pump in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 2 sites 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 14 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 spent between 3.9 and 10 mmol/L. (time frame: 288 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 NCT02846831, 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 11 Jun 2020.