Type 1 DiabetesPhase 2NCT02798250
Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2
A Phase 2 study testing Dual-hormone closed-loop, Insulin and Glucagon in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. 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?
- Dual-hormone closed-loop, Insulin and Glucagon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Mar 2017
- 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 acting insulin analog (Lispro, Aspart or Glulisine).
- 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.
- 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.
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
About this study
In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. With this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large). It is however important to establish the safety of this simplified meal bolus approach. The safety of overestimating a meal insulin bolus in the context of closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone closed-loop will be tested.
Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an adequately estimated meal size bolus.
- Conditions
- Type 1 Diabetes
- Being tested
- Dual-hormone closed-loop, Insulin, Glucagon, Dexcom G4 Platinum glucose sensor, Accu Chek Combo insulin pump
- Keywords
- Type 1 diabetes, Artificial pancreas, Closed-loop system, Postprandial glucose control, 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.
Dual-hormone closed-loopOther
Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, closed-loop will be initiated. At 9:00, a standardized breakfast (45g CHO) will be served. Study subjects will consume the same meal on the two intervention days. During the intervention, patients will be allowed to do sedentary activities. Patients will be allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions. The intervention day will end at 13:00.
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.
Dexcom G4 Platinum glucose sensorDevice
Accu Chek Combo insulin pumpDevice
| Study group | Role | What they receive |
|---|---|---|
| Dual-hormone CL with overestimation of meal size category | Active comparator | A regular size standardized meal of 45g of carbohydrates will be provided to the patient and the meal size will be overestimated by one category, which will result in a meal insulin bolus for a meal of 65g of carbohydrates. Receives: Other: Dual-hormone closed-loop; Drug: Insulin; Drug: Glucagon; Device: Dexcom G4 Platinum glucose sensor; Device: Accu Chek Combo insulin pump |
| Dual-hormone CL with adequate estimation of meal size category | Active comparator | A regular size standardized meal of 45g of carbohydrates will be provided to the patient and the meal size will be adequately estimated, which will result in a meal insulin bolus for a meal of 35g of carbohydrates. Receives: Other: Dual-hormone closed-loop; Drug: Insulin; Drug: Glucagon; Device: Dexcom G4 Platinum glucose sensor; Device: Accu Chek Combo insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time below 4.0 mmol/L
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Secondary outcomes (11)
Mean glucose
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations between 4.0 and 8.0 mmol/L
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations between 4.0 and 10.0 mmol/L
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations below 3.1 mmol/L
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Area under the curve of glucose values below 4.0 mmol/L
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Area under the curve of glucose values below 3.1 mmol/L
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Number of patients with at least one hypoglycemic event with or without symptoms
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total number of hypoglycemic event below 3.1 mmol/L
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total carbohydrate intake for hypoglycemia correction
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total insulin delivery
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total glucagon delivery
Measured: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2017
- Study completionMar 2017
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 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
- NCT02798250
- Sponsor's protocol ID
- CLASS-Safety study - Part 2
- Status last verified
- Apr 2017
- First submitted
- 9 Jun 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2
- ClinicalTrials.gov ID
- NCT02798250
- Acronym / sponsor ID
- CLASS-Safety study - Part 2
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Artificial pancreas, Closed-loop system, Postprandial glucose control, Hypoglycemia, Insulin, Glucagon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Jun 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.
In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. With this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large). It is however important to establish the safety of this simplified meal bolus approach. The safety of overestimating a meal insulin bolus in the context of closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone closed-loop will be tested.
Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an adequately estimated meal size bolus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-hormone CL with overestimation of meal size category | Active comparator | Other: Dual-hormone closed-loop, Drug: Insulin, Drug: Glucagon, Device: Dexcom G4 Platinum glucose sensor, Device: Accu Chek Combo insulin pumpA regular size standardized meal of 45g of carbohydrates will be provided to the patient and the meal size will be overestimated by one category, which will result in a meal insulin bolus for a meal of 65g of carbohydrates. |
| Dual-hormone CL with adequate estimation of meal size category | Active comparator | Other: Dual-hormone closed-loop, Drug: Insulin, Drug: Glucagon, Device: Dexcom G4 Platinum glucose sensor, Device: Accu Chek Combo insulin pumpA regular size standardized meal of 45g of carbohydrates will be provided to the patient and the meal size will be adequately estimated, which will result in a meal insulin bolus for a meal of 35g of carbohydrates. |
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 acting insulin analog (Lispro, Aspart or Glulisine).
- Last (less than 3 months) HbA1c ≤ 10%.
- Currently using carbohydrate counting as the meal insulin dose strategy.
Key exclusion criteria (8 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.
- 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 |
|---|---|---|
| Dual-hormone closed-loopInterventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, closed-loop will be initiated. At 9:00, a standardized breakfast (45g CHO) will be served. Study subjects will consume the same meal on the two intervention days. During the intervention, patients will be allowed to do sedentary activities. Patients will be allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions. The intervention day will end at 13:00. | Other | Dual-hormone CL with adequate estimation of meal size category, Dual-hormone CL with overestimation of meal size category |
| InsulinParticipant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra). | Drug | Dual-hormone CL with adequate estimation of meal size category, Dual-hormone CL with overestimation of meal size category |
| GlucagonGlucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy. | Drug | Dual-hormone CL with adequate estimation of meal size category, Dual-hormone CL with overestimation of meal size category |
| Dexcom G4 Platinum glucose sensor | Device | Dual-hormone CL with adequate estimation of meal size category, Dual-hormone CL with overestimation of meal size category |
| Accu Chek Combo insulin pump | Device | Dual-hormone CL with adequate estimation of meal size category, Dual-hormone CL with overestimation of meal size category |
Primary outcome
Percentage of time below 4.0 mmol/L
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
11 secondary outcomes
Mean glucose
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations between 4.0 and 8.0 mmol/L
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations between 4.0 and 10.0 mmol/L
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Percentage of time of glucose concentrations below 3.1 mmol/L
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Area under the curve of glucose values below 4.0 mmol/L
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Area under the curve of glucose values below 3.1 mmol/L
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Number of patients with at least one hypoglycemic event with or without symptoms
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total number of hypoglycemic event below 3.1 mmol/L
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total carbohydrate intake for hypoglycemia correction
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total insulin delivery
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
Total glucagon delivery
Time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.
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 26 Apr 2017.
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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
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 Dual-hormone closed-loop, Insulin and Glucagon 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 8 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 26 Apr 2017. 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?
Percentage of time below 4.0 mmol/L (time frame: The outcome measure will be calculated over the 4 hours following the breakfast meal. The 4-hour period is from 9:00 to 13:00.). 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 26 Apr 2017.