Type 1 Diabetes MellitusPhase 2NCT03335501
Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels
A Phase 2 study testing Insulin pump, Continuous glucose monitoring system and 11-hour intervention with the single-hormone artificial pancreas in people with Type 1 Diabetes Mellitus, run by Institut de Recherches Cliniques de Montreal.
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 Mellitus
- What is being tested?
- Insulin pump, Continuous glucose monitoring system and 11-hour intervention with the single-hormone artificial pancreas
- 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
- 1 Apr 2018to 31 Dec 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 6 months.
- HbA1c ≤ 12%.
Who cannot join
- Using a patch-pump (e.g. Omnipod)
- 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.
- Ongoing or planned pregnancy.
- Breastfeeding.
- Severe hypoglycemic episode within two weeks of screening.
Show all 11Show fewer
- Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
- Known or suspected allergy to the trial products or meal contents.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
- Problems with venous access.
About this study
Official title: An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels in Adults 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 pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.
Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin pump, Continuous glucose monitoring system, 11-hour intervention with the single-hormone artificial pancreas
- Keywords
- Closed-loop control, Artificial pancreas, Postprandial glucose control, Insulin
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin pumpDevice
The participant's insulin pump will be used to infuse insulin
Continuous glucose monitoring systemDevice
The Dexcom G4 Platinum will be used to measure glucose levels
11-hour intervention with the single-hormone artificial pancreasOther
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations.
At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits.
Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Rapid-acting Aspart | Active comparator | Rapid-acting Aspart will be used to regulate glucose levels Receives: Device: Insulin pump; Device: Continuous glucose monitoring system; Other: 11-hour intervention with the single-hormone artificial pancreas |
| Faster insulin Aspart | Active comparator | Faster insulin Aspart will be used to regulate glucose levels Receives: Device: Insulin pump; Device: Continuous glucose monitoring system; Other: 11-hour intervention with the single-hormone artificial pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma glucose levels 1 hour after the meal
Measured: 1 hour
Secondary outcomes (45)
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
Measured: 1 hour
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
Measured: 2 hours
Plasma glucose level 1 hour after the meal.
Measured: 1 hour
Plasma glucose level 2 hours after the meal.
Measured: 2 hours
Glycemic peak in the 3 hours following the meal.
Measured: 3 hours
Change in plasma glucose levels 2 hours after the meal.
Measured: 2 hours
Peak time of glucose levels over the 4 hours following the meal.
Measured: 4 hours
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
Measured: 4 hours
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
Measured: 11 hours
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
Measured: 11 hours
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
Measured: 11 hours
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
Measured: 11 hours
Percentage of time of plasma glucose levels below 3.9 mmol/L.
Measured: 11 hours
Percentage of time of sensor glucose levels below 3.9 mmol/L.
Measured: 11 hours
Percentage of time of plasma glucose levels below 3.3 mmol/L.
Measured: 11 hours
Percentage of time of sensor glucose levels below 3.3 mmol/L.
Measured: 11 hours
Percentage of time of plasma glucose levels below 2.8 mmol/L.
Measured: 11 hours
Percentage of time of sensor glucose levels below 2.8 mmol/L.
Measured: 11 hours
Percentage of time of plasma glucose levels above 10 mmol/L.
Measured: 11 hours
Percentage of time of sensor glucose levels above 10 mmol/L.
Measured: 11 hours
Percentage of time of plasma glucose levels above 13.9 mmol/L
Measured: 11 hours
Percentage of time of sensor glucose levels above 13.9 mmol/L
Measured: 11 hours
Percentage of time of plasma glucose levels above 16.7 mmol/L.
Measured: 11 hours
Percentage of time of sensor glucose levels above 16.7 mmol/L.
Measured: 11 hours
Area under the curve of plasma glucose levels below 3.9 mmol/L.
Measured: 11 hours
Area under the curve of sensor glucose levels below 3.9 mmol/L.
Measured: 11 hours
Area under the curve of plasma glucose levels below 3.3 mmol/L.
Measured: 11 hours
Area under the curve of sensor glucose levels below 3.3 mmol/L.
Measured: 11 hours
Area under the curve of plasma glucose levels below 2.8 mmol/L.
Measured: 11 hours
Area under the curve of sensor glucose levels below 2.8 mmol/L.
Measured: 11 hours
Area under the curve of plasma glucose levels above 10.0 mmol/L.
Measured: 11 hours
Area under the curve of sensor glucose levels above 10.0 mmol/L.
Measured: 11 hours
Area under the curve of plasma glucose levels above 13.9 mmol/L.
Measured: 11 hours
Area under the curve of sensor glucose levels above 13.9 mmol/L.
Measured: 11 hours
Area under the curve of plasma glucose levels above 16.7 mmol/L.
Measured: 11 hours
Area under the curve of sensor glucose levels above 16.7 mmol/L.
Measured: 11 hours
Standard deviation of plasma glucose levels.
Measured: 11 hours
Standard deviation of sensor glucose levels.
Measured: 11 hours
Coefficient of variance of plasma glucose levels.
Measured: 11 hours
Coefficient of variance of sensor glucose levels.
Measured: 11 hours
Total insulin delivery.
Measured: 11 hours
Mean plasma glucose level.
Measured: 11 hours
Mean sensor glucose level.
Measured: 11 hours
Mean plasma insulin concentration.
Measured: 11 hours
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
Measured: 11 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Apr 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Why it stopped: The owner of the algorithm does not wish that this study be undertaken
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- 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
- Remi Rabasa-Lhoret, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335501
- Sponsor's protocol ID
- CLASS-FiAsp
- Status last verified
- Apr 2018
- First submitted
- 3 Nov 2017
- Last updated
- 27 Apr 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 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03335501
- Acronym / sponsor ID
- CLASS-FiAsp
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Closed-loop control, Artificial pancreas, Postprandial glucose control, Insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The owner of the algorithm does not wish that this study be undertaken
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 7 Nov 2017 (actual)
- 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 pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.
Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid-acting Aspart | Active comparator | Device: Insulin pump, Device: Continuous glucose monitoring system, Other: 11-hour intervention with the single-hormone artificial pancreasRapid-acting Aspart will be used to regulate glucose levels |
| Faster insulin Aspart | Active comparator | Device: Insulin pump, Device: Continuous glucose monitoring system, Other: 11-hour intervention with the single-hormone artificial pancreasFaster insulin Aspart will be used 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 6 months.
- HbA1c ≤ 12%.
Key exclusion criteria (11 listed)
- Using a patch-pump (e.g. Omnipod)
- 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.
- Ongoing or planned pregnancy.
- Breastfeeding.
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 |
|---|---|---|
| Insulin pumpThe participant's insulin pump will be used to infuse insulin | Device | Faster insulin Aspart, Rapid-acting Aspart |
| Continuous glucose monitoring systemThe Dexcom G4 Platinum will be used to measure glucose levels | Device | Faster insulin Aspart, Rapid-acting Aspart |
| 11-hour intervention with the single-hormone artificial pancreasSubjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes. | Other | Faster insulin Aspart, Rapid-acting Aspart |
Primary outcome
Change in plasma glucose levels 1 hour after the meal
Time frame: 1 hour
45 secondary outcomes
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
Time frame: 1 hour
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
Time frame: 2 hours
Plasma glucose level 1 hour after the meal.
Time frame: 1 hour
Plasma glucose level 2 hours after the meal.
Time frame: 2 hours
Glycemic peak in the 3 hours following the meal.
Time frame: 3 hours
Change in plasma glucose levels 2 hours after the meal.
Time frame: 2 hours
Peak time of glucose levels over the 4 hours following the meal.
Time frame: 4 hours
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
Time frame: 4 hours
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels below 3.9 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels below 3.9 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels below 3.3 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels below 3.3 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels below 2.8 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels below 2.8 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels above 10 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels above 10 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels above 13.9 mmol/L
Time frame: 11 hours
Percentage of time of sensor glucose levels above 13.9 mmol/L
Time frame: 11 hours
Percentage of time of plasma glucose levels above 16.7 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels above 16.7 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels below 3.9 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels below 3.9 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels below 3.3 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels below 3.3 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels below 2.8 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels below 2.8 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels above 10.0 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels above 10.0 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels above 13.9 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels above 13.9 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels above 16.7 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels above 16.7 mmol/L.
Time frame: 11 hours
Standard deviation of plasma glucose levels.
Time frame: 11 hours
Standard deviation of sensor glucose levels.
Time frame: 11 hours
Coefficient of variance of plasma glucose levels.
Time frame: 11 hours
Coefficient of variance of sensor glucose levels.
Time frame: 11 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 27 Apr 2018.
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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.
Remi Rabasa-Lhoret principal investigator
Institut de Recherches Cliniques de Montreal
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Insulin pump, Continuous glucose monitoring system and 11-hour intervention with the single-hormone artificial pancreas in people with Type 1 Diabetes Mellitus, run by Institut de Recherches Cliniques de Montreal.
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 11 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 27 Apr 2018. 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?
Change in plasma glucose levels 1 hour after the meal (time frame: 1 hour). 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 27 Apr 2018.