Type 1 DiabetesPhase 2NCT02626936

Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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: 10 participants
Where: 1 siteCanada
Study dates: Jan 2016to Jun 2016
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.
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

Other trials in Canada

About this study

Official title: A Single-blind, Randomized, Two-way, Cross-over Study to Examine the Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation Combined With a Simplified Qualitative Meal-size Estimation in Adults With Type 1 Diabetes

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 safety of this simplified meal bolus approach. The safety of overestimating a meal insulin bolus in the context of single and dual-hormone CLS with the simplified meal strategy needs to be determined. Computer simulation will be used to get a reasonable estimate of risks related to over-estimation with single-hormone closed-loop while over-estimation with dual-hormone closed-loop will be tested in adults with type 1 diabètes

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 one to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00 am. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, CLS will be initiated. At 9:00, a standardized breakfast (75g 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 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 groups in NCT02626936
Study group	Role	What they receive
Dual-hormone CL with overestimation of meal size category	Active comparator	A large size standardized meal of 75g 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 95g 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 large size standardized meal of 75g 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 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

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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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.

Jan 2016Jun 2016

First posted10 Dec 2015 (estimated)
Study startJan 2016
Primary completionJun 2016
Study completionJun 2016

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: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02626936
Sponsor's protocol ID: CLASS Safety meal study
Status last verified: Jun 2016
First submitted: 3 Dec 2015
Last updated: 10 Jun 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-blind, Randomized, Two-way, Cross-over Study to Examine the Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation Combined With a Simplified Qualitative Meal-size Estimation in Adults With Type 1 Diabetes
ClinicalTrials.gov ID: NCT02626936
Acronym / sponsor ID: CLASS Safety meal study
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: 10 participants (actual)
Lead sponsor: Institut de Recherches Cliniques de MontrealUniversity, hospital or other
Study start: Jan 2016
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 10 Dec 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.

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 large size standardized meal of 75g 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 95g 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 large size standardized meal of 75g 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 65g 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 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 (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 one to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00 am. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, CLS will be initiated. At 9:00, a standardized breakfast (75g 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 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 given on the dual-hormone closed-loop intervention. 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 10 Jun 2016.
Individual participant dataSharing planned: No

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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 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 10 Jun 2016. 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 given on the dual-hormone closed-loop intervention. 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?

On the ClinicalTrials.gov record for NCT02626936.

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 10 Jun 2016.