Type 1 DiabetesPhase 2NCT02846857

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 15 Weeks in Adolescents and Adults With Type 1 Diabetes

A Phase 2 study testing 15-week intervention with sensor-augmented pump, 15-week intervention with single-hormone closed-loop and 15-week intervention with dual-hormone closed-loop in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

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?: 15-week intervention with sensor-augmented pump, 15-week intervention with single-hormone closed-loop and 15-week intervention with dual-hormone closed-loop
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: No sites listed yet
Study dates: Start not givento 22 Jul 2019
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 subject will have been on insulin pump therapy for at least 3 months.
HbA1c ≤ 11%.

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 a 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)
Chronic acetaminophen treatment (can interfere with glucose sensor measurements)

Show all 15Show fewer

Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
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
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).
Treatments that could interfere with glucagon

About this study

Official title: An Open-label, Randomized, Multicenter Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 15 Weeks in Free-living Outpatient Conditions in Adolescents and Adults With Type 1 Diabetes

The objective of this study is to compare, in a randomized multicenter trial, the effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented pump therapy with low-glucose suspend in regulating day-and-night glucose levels in outpatient settings for 15 weeks in adolescents and adults.

The investigators hypothesize that dual-hormone closed-loop will reduce time spent in hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy with low-glucose suspend.

Conditions: Type 1 Diabetes
Being tested: 15-week intervention with sensor-augmented pump, 15-week intervention with single-hormone closed-loop, 15-week intervention with dual-hormone closed-loop, Insulin pump, Continuous glucose monitoring system
Keywords: Closed-loop system, Artificial pancreas, Type 1 diabetes, Hypoglycemia, Insulin, Glucagon
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.

15-week intervention with sensor-augmented pumpOther
A sensor will be inserted on the day before the start of the intervention by the participant. 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 15 weeks. Participants will have been previously shown how to use the study insulin pump.
15-week intervention with single-hormone closed-loopOther
A sensor will be inserted on the day before the start of the intervention by the participant. 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 15 weeks.
15-week intervention with dual-hormone closed-loopOther
A sensor will be inserted on the day before the start of the intervention by the participant. 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 15 weeks. Participants will have to reconstitute glucagon everyday.
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)
GlucagonDrug
Glucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.

Study groups in NCT02846857
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: 15-week intervention with sensor-augmented pump; 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: 15-week intervention with single-hormone closed-loop; Device: Insulin pump; Device: Continuous glucose monitoring system; Drug: Insulin
Dual-hormone closed-loop strategy	Active comparator	Variable subcutaneous insulin and glucagon mini-boluses will be infused using two separate subcutaneous infusion pumps to regulate glucose levels (MiniMed® Paradigm® Veo™, Medtronic). Participant's usual fast-acting insulin analog and Glucagon (Eli Lilly) will be used. Every 10 minutes, the glucose level 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 pumps. Newly reconstituted glucagon will be used every 24 hours. Receives: Other: 15-week intervention with dual-hormone closed-loop; Device: Insulin pump; Device: Continuous glucose monitoring system; Drug: Insulin; Drug: Glucagon

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of time of glucose levels below 3.9 mmol/L
Measured: 15 weeks

Secondary outcomes (21)

HbA1c
Measured: 15 weeks
Percentage of time of glucose levels spent in the target range
Target range is defined to be between 4 and 10 mmol/L from 7:00 to 22:00 and between 4 and 7.8 mmol/L from 22:00 to 7:00
Measured: 15 weeks
Area under the curve of glucose levels below 3.9 mmol/L
Measured: 15 weeks
Area under the curve of glucose levels below 3.3 mmol/L
Measured: 15 weeks
Area under the curve of glucose levels below 2.8 mmol/L
Measured: 15 weeks
Percentage of time of glucose levels below 3.3 mmol/L
Measured: 15 weeks
Percentage of time of glucose levels below 2.8 mmol/L
Measured: 15 weeks
Total number of hypoglycemic events below 3.1 mmol/L
Measured: 15 weeks
Percentage of time of glucose levels above 7.8 mmol/L
Measured: 15 weeks
Percentage of time of glucose levels above 10.0 mmol/L
Measured: 15 weeks
Mean glucose levels
Measured: 15 weeks
Standard deviation of glucose levels
Measured: 15 weeks
Coefficient of variation of glucose levels
Measured: 15 weeks
Total daily dose of insulin
Measured: 24 hours
Total daily dose of glucagon
Measured: 24 hours
Percentage of time of closed-loop operation
Measured: 15 weeks
Percentage of time of glucose sensor availability
Measured: 15 weeks
Time between failures due to glucose sensor unavailability
Measured: 15 weeks
Time between failures due to pump connectivity
Measured: 15 weeks
Percentage of time when patients switched back to insulin pump therapy
Measured: 15 weeks
Percentage of time when the closed-loop was automatically switched to insulin pump therapy
Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

?22 Jul 2019

First posted27 Jul 2016 (estimated)
Primary completion22 Jul 2019

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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02846857
Sponsor's protocol ID: CLASS-17
Status last verified: Jul 2019
First submitted: 25 Jul 2016
Last updated: 23 Jul 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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

All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Multicenter Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 15 Weeks in Free-living Outpatient Conditions in Adolescents and Adults With Type 1 Diabetes
ClinicalTrials.gov ID: NCT02846857
Acronym / sponsor ID: CLASS-17
Conditions: Type 1 Diabetes
Keywords: Closed-loop system, Artificial pancreas, Type 1 diabetes, Hypoglycemia, Insulin, Glucagon
Phase: Phase 2
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Institut de Recherches Cliniques de MontrealUniversity, hospital or other
Primary completion: 22 Jul 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Sensor-augmented pump therapy	Active comparator	Other: 15-week intervention with sensor-augmented pump, 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: 15-week intervention with single-hormone closed-loop, 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.
Dual-hormone closed-loop strategy	Active comparator	Other: 15-week intervention with dual-hormone closed-loop, Device: Insulin pump, Device: Continuous glucose monitoring system, Drug: Insulin, Drug: GlucagonVariable subcutaneous insulin and glucagon mini-boluses will be infused using two separate subcutaneous infusion pumps to regulate glucose levels (MiniMed® Paradigm® Veo™, Medtronic). Participant's usual fast-acting insulin analog and Glucagon (Eli Lilly) will be used. Every 10 minutes, the glucose level 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 pumps. Newly reconstituted glucagon will be used every 24 hours.

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 subject will have been on insulin pump therapy for at least 3 months.
HbA1c ≤ 11%.

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 a 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
15-week intervention with sensor-augmented pumpA sensor will be inserted on the day before the start of the intervention by the participant. 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 15 weeks. Participants will have been previously shown how to use the study insulin pump.	Other	Sensor-augmented pump therapy
15-week intervention with single-hormone closed-loopA sensor will be inserted on the day before the start of the intervention by the participant. 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 15 weeks.	Other	Single-hormone closed-loop strategy
15-week intervention with dual-hormone closed-loopA sensor will be inserted on the day before the start of the intervention by the participant. 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 15 weeks. Participants will have to reconstitute glucagon everyday.	Other	Dual-hormone closed-loop strategy
Insulin pumpMiniMed® Paradigm® Veo™, Medtronic	Device	Dual-hormone closed-loop strategy, Sensor-augmented pump therapy, Single-hormone closed-loop strategy
Continuous glucose monitoring systemEnlite sensor®, Medtronic	Device	Dual-hormone closed-loop strategy, 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	Dual-hormone closed-loop strategy, Sensor-augmented pump therapy, Single-hormone closed-loop strategy
GlucagonGlucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.	Drug	Dual-hormone closed-loop strategy

Primary outcome

Percentage of time of glucose levels below 3.9 mmol/L
Time frame: 15 weeks

21 secondary outcomes

HbA1c
Time frame: 15 weeks
Percentage of time of glucose levels spent in the target range
Time frame: 15 weeks
Area under the curve of glucose levels below 3.9 mmol/L
Time frame: 15 weeks
Area under the curve of glucose levels below 3.3 mmol/L
Time frame: 15 weeks
Area under the curve of glucose levels below 2.8 mmol/L
Time frame: 15 weeks
Percentage of time of glucose levels below 3.3 mmol/L
Time frame: 15 weeks
Percentage of time of glucose levels below 2.8 mmol/L
Time frame: 15 weeks
Total number of hypoglycemic events below 3.1 mmol/L
Time frame: 15 weeks
Percentage of time of glucose levels above 7.8 mmol/L
Time frame: 15 weeks
Percentage of time of glucose levels above 10.0 mmol/L
Time frame: 15 weeks
Mean glucose levels
Time frame: 15 weeks
Standard deviation of glucose levels
Time frame: 15 weeks
Coefficient of variation of glucose levels
Time frame: 15 weeks
Total daily dose of insulin
Time frame: 24 hours
Total daily dose of glucagon
Time frame: 24 hours
Percentage of time of closed-loop operation
Time frame: 15 weeks
Percentage of time of glucose sensor availability
Time frame: 15 weeks
Time between failures due to glucose sensor unavailability
Time frame: 15 weeks
Time between failures due to pump connectivity
Time frame: 15 weeks
Percentage of time when patients switched back to insulin pump therapy
Time frame: 15 weeks
Percentage of time when the closed-loop was automatically switched to insulin pump therapy
Time frame: 15 weeks

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 23 Jul 2019.
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

Questions about this trial

What is this clinical trial studying?

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: withdrawn, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

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 below 3.9 mmol/L (time frame: 15 weeks). 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 NCT02846857.

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 Jul 2019.