Type 1 DiabetesPhase 2NCT02416765
Closed-loop Control of Postprandial Glucose Levels in Adults With Type 1 Diabetes
A Phase 2 study testing 15-hour intervention, Insulin (Lispro, Aspart or guilisine) and Glucagon (Eli Lilly) in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
Postprandial meal glucose control with closed-loop systems (CLS) still needs some improvements. In the postprandial period, sensor delay in detecting blood glucose rise after a meal together with delays in insulin absorption expose patients to early risk of hyperglycemia and then to late-postprandial hypoglycemia. 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?
- 15-hour intervention, Insulin (Lispro, Aspart or guilisine) and Glucagon (Eli Lilly)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years 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 and currently using a fast actin insulin analog (Lispro, Aspart or Guilisine).
- Last (less than 3 months) HbA1c ≤ 10%.
- Currently using carbohydrate counting as the meal insulin dose strategy.
Who cannot join
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Ongoing pregnancy.
- Severe hypoglycemic episode within 1 month of screening.
- Agents affecting gastric emptying (Motilium®, Prandase®, Victoza®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, SGLT-2 inhibitors and DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
- Oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone Cortef®). Inhale steroids at stable dose in the last month are acceptable.
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- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. unstable psychiatric condition).
- Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).
- Living or planned travel outside Montreal (> 1h of driving) area during closed-loop procedures.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W1R7
About this study
Official title: An Open-label, Randomized, Five-way, Cross-over Study to Compare the Efficacy of Single- and Dual-hormone Closed-loop Operations Combined With Either Conventional Carbohydrate Counting or a Simplified Qualitative Meal-size Estimation, and Sensor-augmented Pump Therapy in Regulating Glucose Levels in Adults With Type 1 Diabetes
Postprandial meal glucose control with closed-loop systems (CLS) still needs some improvements. In the postprandial period, sensor delay in detecting blood glucose rise after a meal together with delays in insulin absorption expose patients to early risk of hyperglycemia and then to late-postprandial hypoglycemia. Glucagon infusion in dual-hormone CLS has the potential to improve post-meal control as compared to single-hormone CLS allowing a better glucose excursion related to a more aggressive insulin infusion while minimizing hypoglycemic risk. Several approaches have been tested for the determination of prandial boluses during closed-loop operation.
The objective of this study is to test in outpatient unrestricted settings whether, in the context of closed-loop strategy, conventional meal carbohydrate counting could be reduced to a simplified qualitative meal size estimation without a significant degradation in overall glycemic control in adult patients with type 1 diabetes.
The investigators hypothesize that in outpatient free-living conditions: 1) Dual-hormone CLS with partial boluses is equivalent to dual-hormone CLS with full boluses in terms of mean glucose; 2) Single-hormone CLS with partial boluses is equivalent to single-hormone CLS with full boluses in terms of mean glucose. Secondary hypothesis are: 3) Dual-hormone CLS with partial boluses will decrease time in hypoglycemia compared to single-hormone CLS with partial boluses; 4) Dual-hormone CLS with partial boluses is better than sensor-augmented pump therapy in terms of mean glucose; 5) Single-hormone CLS with partial boluses is better than sensor-augmented pump therapy in terms of mean glucose.
- Conditions
- Type 1 Diabetes
- Being tested
- 15-hour intervention, Insulin (Lispro, Aspart or guilisine), Glucagon (Eli Lilly), Closed-loop strategy
- Keywords
- Closed-loop strategy, Artificial pancreas, Postprandial glucose, Insulin, Glucagon, Hypoglycemia, Type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15-hour interventionOther
Interventions will be conducted in outpatient settings. Subject's usual insulin will be used. Meals will not be standardized. Subjects will be allowed to eat whatever and when they want and will be allowed to drink alcohol. Subjects will be allowed to exercise, but they will be asked to do the same amount and intensity of exercise on all intervention visits. Subjects will be accompanied all the time by a member from the research team during closed-loop visits to implement hormonal infusions.
Insulin (Lispro, Aspart or guilisine)Drug
Patient's usual insulin (Lispro, Aspart or guilisine) will be used in all interventions.
Glucagon (Eli Lilly)Drug
In the dual-hormone CLS interventions, glucagon (Eli Lilly) will be used.
Closed-loop strategyOther
Every 10 minutes, the glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom) will be entered manually into the computer. The pumps' infusion rate will then be changed manually based on the computer generated recommendation infusion rates. The computer generated recommendations are based on a predictive algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Sensor-augmented pump therapy | Active comparator | Patients will use conventional pump therapy and freely implement their usual basal rate and CHO-matching full prandial bolus to regulate glucose levels. Receives: Other: 15-hour intervention |
| Single-hormone CLS with full boluses | Active comparator | Variable subcutaneous insulin infusion rates will be used to regulate postprandial glucose levels. Carbohydrate-matching full prandial bolus will be given 10 minutes before the meal. Each subject insulin-to-carbohydrate ratio will be used to calculate the insulin bolus to be given. Receives: Other: 15-hour intervention; Drug: Insulin (Lispro, Aspart or guilisine); Other: Closed-loop strategy |
| Single-hormone CLS with partial boluses | Active comparator | Variable subcutaneous insulin infusion rates will be used to regulate postprandial glucose levels. A pre-meal partial prandial bolus will be given 10 minutes before the meal. The partial bolus will be based on the estimated meal size (snack-regular-large-very large). Meal size will be defined as: snack as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, very large meal for anything above 90g CHO. Receives: Other: 15-hour intervention; Drug: Insulin (Lispro, Aspart or guilisine); Other: Closed-loop strategy |
| Dual-hormone CLS with full boluses | Active comparator | Variable subcutaneous insulin and glucagon infusion rates will be used to regulate postprandial glucose levels. Carbohydrate-matching full prandial bolus will be given 10 minutes before the meal. Each subject insulin-to-carbohydrate ratio will be used to calculate the insulin bolus to be given. Receives: Other: 15-hour intervention; Drug: Insulin (Lispro, Aspart or guilisine); Drug: Glucagon (Eli Lilly); Other: Closed-loop strategy |
| Dual-hormone CLS with partial boluses | Active comparator | Variable subcutaneous insulin and glucagon infusion rates will be used to regulate postprandial glucose levels. A pre-meal partial prandial bolus will be given 10 minutes before the meal. The partial bolus will be based on the estimated meal size (snack-regular-large-very large). Meal size will be defined as: snack as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, very large meal for anything above 90g CHO. Receives: Other: 15-hour intervention; Drug: Insulin (Lispro, Aspart or guilisine); Drug: Glucagon (Eli Lilly); Other: Closed-loop strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean glucose levels as measured by the glucose sensor.
The following comparisons will be done: 1) Dual-hormone CLS with partial boluses vs. dual-hormone CLS with full boluses; 2) Single-hormone CLS with partial boluses vs. single-hormone CLS with full boluses.
Measured: 15 hours
Secondary outcomes (15)
Mean glucose levels as measured by the glucose sensor
The following comparisons will be done: 1) Dual-hormone CLS with partial boluses vs. single-hormone CLS with partial boluses; 2) Dual-hormone CLS with partial boluses vs. sensor-augmented pump therapy; 3) Single-hormone CLS with partial boluses vs. sensor-augmented pump therapy.
Measured: 15 hours
Percentage of time of sensor glucose concentrations between 4 and 8 mmol/L
Measured: 15 hours
Percentage of time of sensor glucose concentrations between 4 and 10 mmol/L
Measured: 15 hours
Percentage of time of sensor glucose concentrations above 10 mmol/L
Measured: 15 hours
Percentage of time of sensor glucose concentrations above 14 mmol/L
Measured: 15 hours
Percentage of time of glucose levels spent below 4 mmol/L
Measured: 15 hours
Percentage of time of glucose levels spent below 3.1 mmol/L
Measured: 15 hours
Area under the curve of glucose values below 4 mmol/L
Measured: 15 hours
Area under the curve of glucose values below 3.1 mmol/L
Measured: 15 hours
Number of patients with at least one hypoglycemic event below 3.1 mmol/L with or without symptoms
Measured: 15 hours
Total number of hypoglycemic event below 3.1 mmol/L
Measured: 15 hours
Total insulin delivery
Measured: 15 hours
Total glucagon delivery
Measured: 15 hours
Standard deviation of glucose levels
Measured: 15 hours
Total carbohydrate intake
Measured: 15 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT02416765
- Sponsor's protocol ID
- CLASS10
- Status last verified
- Nov 2015
- First submitted
- 2 Apr 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Five-way, Cross-over Study to Compare the Efficacy of Single- and Dual-hormone Closed-loop Operations Combined With Either Conventional Carbohydrate Counting or a Simplified Qualitative Meal-size Estimation, and Sensor-augmented Pump Therapy in Regulating Glucose Levels in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02416765
- Acronym / sponsor ID
- CLASS10
- Conditions
- Type 1 Diabetes
- Keywords
- Closed-loop strategy, Artificial pancreas, Postprandial glucose, Insulin, Glucagon, Hypoglycemia, Type 1 diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Apr 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.
Postprandial meal glucose control with closed-loop systems (CLS) still needs some improvements. In the postprandial period, sensor delay in detecting blood glucose rise after a meal together with delays in insulin absorption expose patients to early risk of hyperglycemia and then to late-postprandial hypoglycemia. Glucagon infusion in dual-hormone CLS has the potential to improve post-meal control as compared to single-hormone CLS allowing a better glucose excursion related to a more aggressive insulin infusion while minimizing hypoglycemic risk. Several approaches have been tested for the determination of prandial boluses during closed-loop operation.
The objective of this study is to test in outpatient unrestricted settings whether, in the context of closed-loop strategy, conventional meal carbohydrate counting could be reduced to a simplified qualitative meal size estimation without a significant degradation in overall glycemic control in adult patients with type 1 diabetes.
The investigators hypothesize that in outpatient free-living conditions: 1) Dual-hormone CLS with partial boluses is equivalent to dual-hormone CLS with full boluses in terms of mean glucose; 2) Single-hormone CLS with partial boluses is equivalent to single-hormone CLS with full boluses in terms of mean glucose. Secondary hypothesis are: 3) Dual-hormone CLS with partial boluses will decrease time in hypoglycemia compared to single-hormone CLS with partial boluses; 4) Dual-hormone CLS with partial boluses is better than sensor-augmented pump therapy in terms of mean glucose; 5) Single-hormone CLS with partial boluses is better than sensor-augmented pump therapy in terms of mean glucose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sensor-augmented pump therapy | Active comparator | Other: 15-hour interventionPatients will use conventional pump therapy and freely implement their usual basal rate and CHO-matching full prandial bolus to regulate glucose levels. |
| Single-hormone CLS with full boluses | Active comparator | Other: 15-hour intervention, Drug: Insulin (Lispro, Aspart or guilisine), Other: Closed-loop strategyVariable subcutaneous insulin infusion rates will be used to regulate postprandial glucose levels. Carbohydrate-matching full prandial bolus will be given 10 minutes before the meal. Each subject insulin-to-carbohydrate ratio will be used to calculate the insulin bolus to be given. |
| Single-hormone CLS with partial boluses | Active comparator | Other: 15-hour intervention, Drug: Insulin (Lispro, Aspart or guilisine), Other: Closed-loop strategyVariable subcutaneous insulin infusion rates will be used to regulate postprandial glucose levels. A pre-meal partial prandial bolus will be given 10 minutes before the meal. The partial bolus will be based on the estimated meal size (snack-regular-large-very large). Meal size will be defined as: snack as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, very large meal for anything above 90g CHO. |
| Dual-hormone CLS with full boluses | Active comparator | Other: 15-hour intervention, Drug: Insulin (Lispro, Aspart or guilisine), Drug: Glucagon (Eli Lilly), Other: Closed-loop strategyVariable subcutaneous insulin and glucagon infusion rates will be used to regulate postprandial glucose levels. Carbohydrate-matching full prandial bolus will be given 10 minutes before the meal. Each subject insulin-to-carbohydrate ratio will be used to calculate the insulin bolus to be given. |
| Dual-hormone CLS with partial boluses | Active comparator | Other: 15-hour intervention, Drug: Insulin (Lispro, Aspart or guilisine), Drug: Glucagon (Eli Lilly), Other: Closed-loop strategyVariable subcutaneous insulin and glucagon infusion rates will be used to regulate postprandial glucose levels. A pre-meal partial prandial bolus will be given 10 minutes before the meal. The partial bolus will be based on the estimated meal size (snack-regular-large-very large). Meal size will be defined as: snack as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, very large meal for anything above 90g CHO. |
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 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 and currently using a fast actin insulin analog (Lispro, Aspart or Guilisine).
- Last (less than 3 months) HbA1c ≤ 10%.
- Currently using carbohydrate counting as the meal insulin dose strategy.
Key exclusion criteria (9 listed)
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Ongoing pregnancy.
- Severe hypoglycemic episode within 1 month of screening.
- Agents affecting gastric emptying (Motilium®, Prandase®, Victoza®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, SGLT-2 inhibitors and DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
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-hour interventionInterventions will be conducted in outpatient settings. Subject's usual insulin will be used. Meals will not be standardized. Subjects will be allowed to eat whatever and when they want and will be allowed to drink alcohol. Subjects will be allowed to exercise, but they will be asked to do the same amount and intensity of exercise on all intervention visits. Subjects will be accompanied all the time by a member from the research team during closed-loop visits to implement hormonal infusions. | Other | Dual-hormone CLS with full boluses, Dual-hormone CLS with partial boluses, Sensor-augmented pump therapy, Single-hormone CLS with full boluses, Single-hormone CLS with partial boluses |
| Insulin (Lispro, Aspart or guilisine)Patient's usual insulin (Lispro, Aspart or guilisine) will be used in all interventions. | Drug | Dual-hormone CLS with full boluses, Dual-hormone CLS with partial boluses, Single-hormone CLS with full boluses, Single-hormone CLS with partial boluses |
| Glucagon (Eli Lilly)In the dual-hormone CLS interventions, glucagon (Eli Lilly) will be used. | Drug | Dual-hormone CLS with full boluses, Dual-hormone CLS with partial boluses |
| Closed-loop strategyEvery 10 minutes, the glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom) will be entered manually into the computer. The pumps' infusion rate will then be changed manually based on the computer generated recommendation infusion rates. The computer generated recommendations are based on a predictive algorithm. | Other | Dual-hormone CLS with full boluses, Dual-hormone CLS with partial boluses, Single-hormone CLS with full boluses, Single-hormone CLS with partial boluses |
Primary outcome
Mean glucose levels as measured by the glucose sensor.
Time frame: 15 hours
The following comparisons will be done: 1) Dual-hormone CLS with partial boluses vs. dual-hormone CLS with full boluses; 2) Single-hormone CLS with partial boluses vs. single-hormone CLS with full boluses.
15 secondary outcomes
Mean glucose levels as measured by the glucose sensor
Time frame: 15 hours
Percentage of time of sensor glucose concentrations between 4 and 8 mmol/L
Time frame: 15 hours
Percentage of time of sensor glucose concentrations between 4 and 10 mmol/L
Time frame: 15 hours
Percentage of time of sensor glucose concentrations above 10 mmol/L
Time frame: 15 hours
Percentage of time of sensor glucose concentrations above 14 mmol/L
Time frame: 15 hours
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: 15 hours
Percentage of time of glucose levels spent below 3.1 mmol/L
Time frame: 15 hours
Area under the curve of glucose values below 4 mmol/L
Time frame: 15 hours
Area under the curve of glucose values below 3.1 mmol/L
Time frame: 15 hours
Number of patients with at least one hypoglycemic event below 3.1 mmol/L with or without symptoms
Time frame: 15 hours
Total number of hypoglycemic event below 3.1 mmol/L
Time frame: 15 hours
Total insulin delivery
Time frame: 15 hours
Total glucagon delivery
Time frame: 15 hours
Standard deviation of glucose levels
Time frame: 15 hours
Total carbohydrate intake
Time frame: 15 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 16 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémi Rabasa-Lhoret 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 15-hour intervention, Insulin (Lispro, Aspart or guilisine) and Glucagon (Eli Lilly) 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: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean glucose levels as measured by the glucose sensor. (time frame: 15 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 16 Nov 2015.