type1diabetesPhase 2/3FCLNCT06046417
A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes
A Phase 2/3 study testing Pramlintide, Lyumjev and Automated Insulin Delivery (AID) system in people with type1diabetes and Diabetes Mellitus, Type 1, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The aim of this clinical trial is to investigate whether a fully automated Lyumjev-and-pramlintide delivery system improves glycemic outcomes in adults with type 1 diabetes. The main question we aim to answer is whether a Lyumjev-pramlintide fully closed loop system improves time in range compared to a hybrid closed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- type1diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- Pramlintide, Lyumjev and Automated Insulin Delivery (AID) system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2023to Jun 2025
- Phase
- Phase 2/3
- 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
- Individuals ≥ 18 years of age.
- A clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes relies on the investigator's judgment; C peptide level and antibody determinations are unnecessary.
- Using insulin pump therapy for at least three months.
- Individuals of childbearing potential using an effective birth-control method. An individual of childbearing potential must agree to use a highly effective method of birth control.
Who cannot join
- Current or recent use of antihyperglycemic agents other than insulin (≤ 2-week use of sodium-glucose cotransporter-2 inhibitor (SGLT2I), Metformin, etc.; ≤ 1-month for glucagon-like peptide-1 receptor agonists (GLP1-RA)).
- Current use of glucocorticoid medication (except low, stable doses and inhaled steroids).
- Individuals with confirmed gastroparesis.
- Use of medication that alters gastrointestinal motility (ex: domperidone).
- Use of hydroxyurea.
- Planned or ongoing pregnancy.
Show all 13Show fewer
- Breastfeeding individuals.
- Severe hypoglycemia requiring hospitalization in the past month. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.
- Diabetic ketoacidosis episode in the past month.
- Clinically significant nephropathy, neuropathy, or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event, e.g., acute coronary syndrome.
- Other serious medical illnesses which are likely to interfere with study participation or the ability to complete the trial by the investigator's judgment.
- Known hypersensitivity to the study drugs or their excipients.
Trial locations and contacts
1 site in 1 country.
Ahmad Haidar, PhD. contact
Canada1 site, 1 recruiting
- Recruiting
Research Institute of the McGill University Health Center
Montreal, Quebec, H4A 3J1
Joelle Doumat, BSc., 832-798-3648, joelle.doumat@mail.mcgill.ca
Michael Tsoukas, M.D
About this study
Official title: A Randomized, Controlled, Crossover Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Delivery System Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes.
The aim of this clinical trial is to investigate whether a fully automated Lyumjev-and-pramlintide delivery system improves glycemic outcomes in adults with type 1 diabetes. The main question we aim to answer is whether a Lyumjev-pramlintide fully closed loop system improves time in range compared to a hybrid closed loop system with carbohydrate counting. We also aim to find the optimal insulin to pramlintide ratio for glycemic control in the fully automated system.
In this cross-over study, patients will undergo the following three interventions in a random order:
Read more
(i) fully automated Lyumjev insulin-and-pramlintide (8 μg/u) (ii) fully automated Lyumjev insulin-and-pramlintide (10 μg/u) (iii) rapid automated Lyumjev insulin-and-placebo with carbohydrate-matched boluses
For all interventions, participants will be required to wear two Ypsomed pumps programmed by our developed EuGlide system.
Read the detailed description
The aim of this study is to conduct an outpatient, randomized, crossover clinical trial to compare the glycemic outcomes of a fully automated Lyumjev-pramlintide delivery system to a hybrid automated Lyumjev-placebo delivery system with carbohydrate counting in 26 adults with type 1 diabetes.
Design-
All participants will undergo three interventions in a random order:
(i) Fully automated Lyumjev insulin-pramlintide delivery system. Ratio of 1 unit of inulin for 8μg of pramlintide.
(ii) Fully automated Lyumjev insulin-pramlintide delivery system. Ratio of 1 unit of insulin for 10μg of pramlintide.
(iii) Hybrid automated Lyumjev insulin-placebo delivery system with carbohydrate-matched boluses.
Study drugs-
Lyumjev is a Health Canada insulin for treatment of type 1 diabetes. Participants who do not currently use Lyumjev will be switched to it for the duration of the study.
Pramlintide is an FDA-approved drug used in the treatment of type 1 diabetes. It contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion and increasing satiety. It is not approved for commercial use by Health Canada, but has been approved for the purpose of the study.
Study Devices-
For the duration of the study, participants will use a Dexcom G6 Continuous Glucose Monitor (GCM), two YpsoPumps (for insulin and pramlintide) as well as a study smartphone with the Euglide application installed. The automated insulin delivery (AID) system will integrate these sets of devices to automate insulin (and pramlintide) delivery in response to an individual's glucose levels.
Treatment Period-
Each intervention will last three weeks and be preceded by a 5-day at-home run-in period. After both the second and third interventions, there will be a 14-45 day washout period. Participants will be followed-up with remotely on days 2 (+/-1) and 5 of each run-in and on days 2(+/-1), 3(+/-1) and 7(+/-2) of each intervention. Remote contact can be performed via phone, email, text message or another reasonable communication channel. After each intervention, participants will be interviewed and asked to complete questionnaires assessing diabetes control and quality of life. Participants will need approximately 15-30 weeks to complete the study.
The study will enroll up to 4 pilot participants, as well as 26 main study participants who meet the eligibility criteria.
- Conditions
- type1diabetes, Diabetes Mellitus, Type 1
- Being tested
- Pramlintide, Lyumjev, Automated Insulin Delivery (AID) system
- Keywords
- Pramlintide, fully automated delivery system, artificial pancreas, Insulin, Lyumjev, fully closed loop, adjunctive
- 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.
PramlintideDrug
Pramlintide delivered in a basal-bolus manner.
LyumjevDrug
Lyumjev delivered in a basal-bolus manner.
Automated Insulin Delivery (AID) systemDevice
The AID system consists of a set of devices that work inter-connectedly to automate insulin (and pramlintide) delivery in response to an individual's glucose levels. It consists of a (i) Dexcom G6 glucose sensor, (ii) a smartphone-based algorithm, (iii) an insulin YpsoPump, and (iv) a pramlintide/placebo YpsoPump in a dual hormone configuration.
| Study group | Role | What they receive |
|---|---|---|
| Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u) | Experimental | Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 8 μg of pramlintide. Receives: Drug: Pramlintide; Drug: Lyumjev; Device: Automated Insulin Delivery (AID) system |
| Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u) | Experimental | Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 10 μg of pramlintide. Receives: Drug: Pramlintide; Drug: Lyumjev; Device: Automated Insulin Delivery (AID) system |
| Hybrid automated Lyumjev-and-placebo delivery system with carbohydrate-matched boluses | Active comparator | Lyumjev and saline placebo hybrid automated delivery system with meal announcement. Participants must input the carbohydrate content of their meals to inform the insulin bolus doses based on their pre-programmed insulin-to-carbohydrate ratios. Receives: Drug: Lyumjev |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).
Measured: 18 days
Secondary outcomes (14)
Percentage of time of glucose levels spent between 3.9-7.8 mmol/L.
Measured: 18 days
Percentage of time of glucose levels spent between 3.0-3.9 mmol/L.
Measured: 18 days
Percentage of time of glucose levels spent between 10.0-13.9 mmol/L.
Measured: 18 days
Mean glucose levels.
Measured: 18 days
Standard deviation of glucose levels.
Measured: 18 days
Coefficient of variance of glucose levels.
Measured: 18 days
Total pramlintide delivery (overall, basal, and bolus).
Measured: 18 days
Total insulin delivery (overall, basal, and bolus).
Measured: 18 days
Mean score on the Type 1 Diabetes Distress Scale (T1DDS) excluding the physician subscale.
A scale from 1-6 indicating overall diabetes distress. Higher scores indicate higher levels of diabetes distress. Any total subscale score of >2.0 is considered clinically significant.
Measured: 18 days
Mean score on the Hypoglycemia Fear Survey - II (Worry Subscale) (HSF2).
A scale from 1-5 with higher scores indicating a greater fear of hypoglycemia.
Measured: 18 days
Mean score on the INSPIRE questionnaire for adults (INSPIRE).
A scale from 1-5 with higher scores reflecting more favorable opinions about using Automated Insulin Delivery (AID).
Measured: 18 days
Mean score on selected items from The Diabetes Bowel Symptoms Questionnaire (DBSQ).
A 1-5 scale with higher values reflecting a greater quantity and severity of diabetes bowel symptoms.
Measured: 18 days
Mean score on a Treatment Satisfaction Questionnaire (TSQ) taken from Marrero et al.
A 1-6 scale with higher values indicating more satisfaction with treatment.
Measured: 18 days
Thematic interview analysis
Semi-structured interviews will be carried out after every intervention. We will analyze their qualitative content.
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start30 Nov 2023
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for type1diabetesStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Michael Tsoukas, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Michael Tsoukas, M.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreAhmad Haidar, Ph.D., Study chair, McGill University Health Centre/Research Institute of the McGill University Health CentreLaurent Legault, M.D., Study chair, Montreal's Children's Hospital Division of EndocrinologyMichael Vallis, Ph.D., Study chair, Dalhousie University PsychologistNatasha Garfield, M.D., Study chair, Royal Victoria Hospital Division of EndocrinologyMelissa-Rosina Pasqua, M.D., Study chair, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046417
- Sponsor's protocol ID
- 2023-9373
- Acronym
- FCL
- Status last verified
- Apr 2024
- First submitted
- 12 Sep 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data (that is, insulin delivery, glucose levels and individual participant data) and informed consent form will be shared by the corresponding author, for academic purposes, subject to a material transfer agreement and approval of the McGill University Health Center's Research Ethics Board. All data shared will be de-identified. Raw data will be shared for non-commercial use upon reasonable request and a material transfer agreement.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Crossover Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Delivery System Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT06046417
- Acronym / sponsor ID
- FCL / 2023-9373
- Conditions
- type1diabetes, Diabetes Mellitus, Type 1
- Keywords
- Pramlintide, fully automated delivery system, artificial pancreas, Insulin, Lyumjev, fully closed loop, adjunctive
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 21 Sep 2023 (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.
The aim of this clinical trial is to investigate whether a fully automated Lyumjev-and-pramlintide delivery system improves glycemic outcomes in adults with type 1 diabetes. The main question we aim to answer is whether a Lyumjev-pramlintide fully closed loop system improves time in range compared to a hybrid closed loop system with carbohydrate counting. We also aim to find the optimal insulin to pramlintide ratio for glycemic control in the fully automated system.
In this cross-over study, patients will undergo the following three interventions in a random order:
(i) fully automated Lyumjev insulin-and-pramlintide (8 μg/u) (ii) fully automated Lyumjev insulin-and-pramlintide (10 μg/u) (iii) rapid automated Lyumjev insulin-and-placebo with carbohydrate-matched boluses
For all interventions, participants will be required to wear two Ypsomed pumps programmed by our developed EuGlide system.
Detailed description
The aim of this study is to conduct an outpatient, randomized, crossover clinical trial to compare the glycemic outcomes of a fully automated Lyumjev-pramlintide delivery system to a hybrid automated Lyumjev-placebo delivery system with carbohydrate counting in 26 adults with type 1 diabetes.
Design-
All participants will undergo three interventions in a random order:
(i) Fully automated Lyumjev insulin-pramlintide delivery system. Ratio of 1 unit of inulin for 8μg of pramlintide.
(ii) Fully automated Lyumjev insulin-pramlintide delivery system. Ratio of 1 unit of insulin for 10μg of pramlintide.
(iii) Hybrid automated Lyumjev insulin-placebo delivery system with carbohydrate-matched boluses.
Study drugs-
Lyumjev is a Health Canada insulin for treatment of type 1 diabetes. Participants who do not currently use Lyumjev will be switched to it for the duration of the study.
Pramlintide is an FDA-approved drug used in the treatment of type 1 diabetes. It contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion and increasing satiety. It is not approved for commercial use by Health Canada, but has been approved for the purpose of the study.
Study Devices-
For the duration of the study, participants will use a Dexcom G6 Continuous Glucose Monitor (GCM), two YpsoPumps (for insulin and pramlintide) as well as a study smartphone with the Euglide application installed. The automated insulin delivery (AID) system will integrate these sets of devices to automate insulin (and pramlintide) delivery in response to an individual's glucose levels.
Treatment Period-
Each intervention will last three weeks and be preceded by a 5-day at-home run-in period. After both the second and third interventions, there will be a 14-45 day washout period. Participants will be followed-up with remotely on days 2 (+/-1) and 5 of each run-in and on days 2(+/-1), 3(+/-1) and 7(+/-2) of each intervention. Remote contact can be performed via phone, email, text message or another reasonable communication channel. After each intervention, participants will be interviewed and asked to complete questionnaires assessing diabetes control and quality of life. Participants will need approximately 15-30 weeks to complete the study.
The study will enroll up to 4 pilot participants, as well as 26 main study participants who meet the eligibility criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u) | Experimental | Drug: Pramlintide, Drug: Lyumjev, Device: Automated Insulin Delivery (AID) systemLyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 8 μg of pramlintide. |
| Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u) | Experimental | Drug: Pramlintide, Drug: Lyumjev, Device: Automated Insulin Delivery (AID) systemLyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 10 μg of pramlintide. |
| Hybrid automated Lyumjev-and-placebo delivery system with carbohydrate-matched boluses | Active comparator | Drug: LyumjevLyumjev and saline placebo hybrid automated delivery system with meal announcement. Participants must input the carbohydrate content of their meals to inform the insulin bolus doses based on their pre-programmed insulin-to-carbohydrate ratios. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals ≥ 18 years of age.
- A clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes relies on the investigator's judgment; C peptide level and antibody determinations are unnecessary.
- Using insulin pump therapy for at least three months.
- Individuals of childbearing potential using an effective birth-control method. An individual of childbearing potential must agree to use a highly effective method of birth control.
Key exclusion criteria (13 listed)
- Current or recent use of antihyperglycemic agents other than insulin (≤ 2-week use of sodium-glucose cotransporter-2 inhibitor (SGLT2I), Metformin, etc.; ≤ 1-month for glucagon-like peptide-1 receptor agonists (GLP1-RA)).
- Current use of glucocorticoid medication (except low, stable doses and inhaled steroids).
- Individuals with confirmed gastroparesis.
- Use of medication that alters gastrointestinal motility (ex: domperidone).
- Use of hydroxyurea.
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 |
|---|---|---|
| PramlintidePramlintide delivered in a basal-bolus manner. | Drug | Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u), Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u) |
| LyumjevLyumjev delivered in a basal-bolus manner. | Drug | Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u), Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u), Hybrid automated Lyumjev-and-placebo delivery system with carbohydrate-matched boluses |
| Automated Insulin Delivery (AID) systemThe AID system consists of a set of devices that work inter-connectedly to automate insulin (and pramlintide) delivery in response to an individual's glucose levels. It consists of a (i) Dexcom G6 glucose sensor, (ii) a smartphone-based algorithm, (iii) an insulin YpsoPump, and (iv) a pramlintide/placebo YpsoPump in a dual hormone configuration. | Device | Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u), Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u) |
Primary outcome
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).
Time frame: 18 days
14 secondary outcomes
Percentage of time of glucose levels spent between 3.9-7.8 mmol/L.
Time frame: 18 days
Percentage of time of glucose levels spent between 3.0-3.9 mmol/L.
Time frame: 18 days
Percentage of time of glucose levels spent between 10.0-13.9 mmol/L.
Time frame: 18 days
Mean glucose levels.
Time frame: 18 days
Standard deviation of glucose levels.
Time frame: 18 days
Coefficient of variance of glucose levels.
Time frame: 18 days
Total pramlintide delivery (overall, basal, and bolus).
Time frame: 18 days
Total insulin delivery (overall, basal, and bolus).
Time frame: 18 days
Mean score on the Type 1 Diabetes Distress Scale (T1DDS) excluding the physician subscale.
Time frame: 18 days
Mean score on the Hypoglycemia Fear Survey - II (Worry Subscale) (HSF2).
Time frame: 18 days
Mean score on the INSPIRE questionnaire for adults (INSPIRE).
Time frame: 18 days
Mean score on selected items from The Diabetes Bowel Symptoms Questionnaire (DBSQ).
Time frame: 18 days
Mean score on a Treatment Satisfaction Questionnaire (TSQ) taken from Marrero et al.
Time frame: 18 days
Thematic interview analysis
Time frame: 18 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Yes. The raw data (that is, insulin delivery, glucose levels and individual participant data) and informed consent form will be shared by the corresponding author, for academic purposes, subject to a material transfer agreement and approval of the McGill University Health Center's Research Ethics Board. All data shared will be de-identified. Raw data will be shared for non-commercial use upon reasonable request and a material transfer agreement.
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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.
Ahmad Haidar, PhD. contact
Michael Tsoukas, M.D. principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Ahmad Haidar, Ph.D. study chair
McGill University Health Centre/Research Institute of the McGill University Health Centre
Laurent Legault, M.D. study chair
Montreal's Children's Hospital Division of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pramlintide, Lyumjev and Automated Insulin Delivery (AID) system in people with type1diabetes and Diabetes Mellitus, Type 1, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 18 Apr 2024. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joelle Doumat, BSc. (832-798-3648, joelle.doumat@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L). (time frame: 18 days). 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 18 Apr 2024.