Type 1 DiabetesFCLNCT05199714
A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes
A study testing Fiasp, Artificial Pancreas and Pramlintide in people with Type 1 Diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The investigators aim to assess the glycemic outcomes of a fully automated insulin-and-pramlintide artificial pancreas and a comparator insulin-alone artificial pancreas with carbohydrate matched boluses. 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?
- Fiasp, Artificial Pancreas and Pramlintide
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 21 Feb 2022to 25 Mar 2023
- Phase
- Interventional
- 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
- Females and males ≥ 18 years of age.
- Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Use of insulin pump therapy for at least 3 months.
- Effective birth-control use in individuals of childbearing potential. Individuals of child-bearing potential must agree to use a highly effective method of birth control.
Who cannot join
- Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2I (sodium-glucose transporter), GLP-1(glucagon-like peptide), Metformin, etc.).
- Current use of glucocorticoid medication (except low, stable does and inhaled steroids).
- Individuals with confirmed gastroparesis.
- Use of medication that alters gastrointestinal motility.
- Planned or ongoing pregnancy.
- Breastfeeding individuals.
Show all 11Show fewer
- Severe hypoglycemia requiring hospitalization in the past three months.
- Severe diabetic ketoacidosis episode in the past three months.
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Institute of the McGill University Health Center
Montreal, Quebec, H4A 3T2
About this study
Official title: A Randomized, Controlled, Crossover Pilot Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Artificial Pancreas Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes
The investigators aim to assess the glycemic outcomes of a fully automated insulin-and-pramlintide artificial pancreas and a comparator insulin-alone artificial pancreas with carbohydrate matched boluses.
Read the detailed description
The aim of this pilot study is to generate additional data of (i) a Fiasp-alone artificial pancreas with carbohydrate-matched boluses, compared to (ii) a Fiasp-plus-Pramlintide fully automated artificial pancreas with no meal announcement in an outpatient free-living setting. The study is not powered, nor aims to answer a scientific hypothesis related to the efficacy of the pramlintide and insulin closed-loop systems.
Design
The investigators will undertake a randomized crossover study to compare the following strategies:
- Insulin-alone artificial pancreas with carbohydrate-matched boluses
- Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
- Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide. Each participant will be offered the opportunity to further participate in two optional additional arms:
- Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
- Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
Aspart is used in this optional arm as it is the slower-acting version of Fiasp and can therefore be used to draw reasonable comparisons. Further, Aspart is an FDA approved insulin which is commonly sold and prescribed in North America. Several co-formulations are being developed with insulin, pramlintide, and glucagon. Given the widespread adoption and use of Aspart, it makes this insulin a good candidate for use in co-formulations and an excellent option for transition to market, where they will impact many individuals living with diabetes.
Treatment period: Each intervention will last 14 hours. At-home run-ins, lasting two to four days, will occur prior to the pramlintide interventions. The interventions containing pramlintide with the same insulin will occur in sequence, one immediately after the other. The first pramlintide-and-Fiasp intervention will use a ratio of 8μg pramlintide/1unit of insulin and will be followed by the second pramlintide-and-Fiasp intervention the next day with a 10μg/1unit ratio. A similar schedule will be applied to the optional Aspart-and-pramlintide interventions. There will be a 2-29-day washout period between the Fiasp-and-pramlintide, Fiasp-alone, and Aspart-and-pramlintide interventions. Participants will be followed up remotely 1-2 days after the end of each intervention to ensure their washout period is going smoothly and will inquire about any adverse events. Remote contact can be performed via phone, email, text message or other reasonable communication channel. Participants will also be followed up remotely 1-2 days and 1-2 weeks after the end of their participation in the study.
- Conditions
- Type 1 Diabetes
- Being tested
- Fiasp, Artificial Pancreas, Pramlintide, Aspart
- Keywords
- Artificial Pancreas, Insulin, Pramlintide, Aspart, Fiasp
- 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.
FiaspDrug
Fiasp Insulin delivered in a basal-bolus manner.
Artificial PancreasDevice
Medtronic insulin pump, Dexcom G6 continuous glucose sensor, tablet running the Artificial Pancreas Algorithm.
PramlintideDrug
Pramlintide delivered in a basal-bolus manner.
AspartDrug
Aspart insulin delivered in a basal-bolus manner.
| Study group | Role | What they receive |
|---|---|---|
| Fiasp-and-pramlintide fully automated system (8μg) | Experimental | Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide. Receives: Drug: Fiasp; Device: Artificial Pancreas; Drug: Pramlintide |
| Fiasp-alone with carbohydrate-matched boluses | Active comparator | The Fiasp-alone intervention will have a 14 hour duration. During which, carbohydrate counting will inform insulin bolus doses based on insulin to carbohydrate ratios. Receives: Drug: Fiasp |
| Aspart-and-pramlintide fully automated system (10μg) | Experimental | Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide. Receives: Device: Artificial Pancreas; Drug: Pramlintide; Drug: Aspart |
| Fiasp-and-pramlintide fully automated system (10μg) | Experimental | Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide. Receives: Drug: Fiasp; Device: Artificial Pancreas; Drug: Pramlintide |
| Aspart-and-pramlintide fully automated system (8μg) | Experimental | Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide. Receives: Device: Artificial Pancreas; Drug: Pramlintide; Drug: Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Each participant's percentage of time glucose levels spent in the target range
Time in target range (3.9-10.0 mmol/L).
Measured: 42 +/- 28 hours
Secondary outcomes (13)
Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Glucose data will be collected from a glucose sensor and numerical glucose data will be analyzed as a function of time
Measured: 42 +/- 28 hours
Each participant's percentage of time of glucose levels spent below 3.9 mmol/L
Glucose data will be collected from a glucose sensor and numerical glucose data will be analyzed as a function of time
Measured: 42 +/- 28 hours
Each participant's percentage of time of glucose levels spent below 3.0 mmol/L
Glucose data will be collected from a glucose sensor and numerical glucose data will be analyzed as a function of time
Measured: 42 +/- 28 hours
Each participant's percentage of time of glucose levels spent above 10.0 mmol/L
Glucose data will be collected from a glucose sensor and numerical glucose data will be analyzed as a function of time
Measured: 42 +/- 28 hours
Each participant's percentage of time of glucose levels spent above 13.9 mmol/L
Glucose data will be collected from a glucose sensor and numerical glucose data will be analyzed as a function of time
Measured: 42 +/- 28 hours
Each participant's percentage of time of glucose levels spent above 16.7 mmol/L
Glucose data will be collected from a glucose sensor and numerical glucose data will be analyzed as a function of time
Measured: 42 +/- 28 hours
Each participant's mean glucose levels
Measured: 42 +/- 28 hours
Each participant's standard deviation of glucose levels
Measured: 42 +/- 28 hours
Each participant's coefficient of variance of glucose levels
Measured: 42 +/- 28 hours
Total pramlintide delivery for each participant
Measured: 28 +/- 28 hours
Total insulin delivery for each participant
Measured: 42 +/- 28 hours
Total basal insulin delivery for each participant
Measured: 42 +/- 28 hours
Total bolus insulin delivery for each participant
Measured: 42 +/- 28 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start21 Feb 2022
- Primary completion25 Mar 2023
- Study completion25 Mar 2023
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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 Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199714
- Sponsor's protocol ID
- 2022-8225
- Acronym
- FCL
- Status last verified
- Oct 2023
- First submitted
- 13 Dec 2021
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Crossover Pilot Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Artificial Pancreas Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05199714
- Acronym / sponsor ID
- FCL / 2022-8225
- Conditions
- Type 1 Diabetes
- Keywords
- Artificial Pancreas, Insulin, Pramlintide, Aspart, Fiasp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 25 Mar 2023 (actual)
- First posted
- 20 Jan 2022 (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 investigators aim to assess the glycemic outcomes of a fully automated insulin-and-pramlintide artificial pancreas and a comparator insulin-alone artificial pancreas with carbohydrate matched boluses.
Detailed description
The aim of this pilot study is to generate additional data of (i) a Fiasp-alone artificial pancreas with carbohydrate-matched boluses, compared to (ii) a Fiasp-plus-Pramlintide fully automated artificial pancreas with no meal announcement in an outpatient free-living setting. The study is not powered, nor aims to answer a scientific hypothesis related to the efficacy of the pramlintide and insulin closed-loop systems.
Design
The investigators will undertake a randomized crossover study to compare the following strategies:
- Insulin-alone artificial pancreas with carbohydrate-matched boluses
- Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
- Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide. Each participant will be offered the opportunity to further participate in two optional additional arms:
- Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
- Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
Aspart is used in this optional arm as it is the slower-acting version of Fiasp and can therefore be used to draw reasonable comparisons. Further, Aspart is an FDA approved insulin which is commonly sold and prescribed in North America. Several co-formulations are being developed with insulin, pramlintide, and glucagon. Given the widespread adoption and use of Aspart, it makes this insulin a good candidate for use in co-formulations and an excellent option for transition to market, where they will impact many individuals living with diabetes.
Treatment period: Each intervention will last 14 hours. At-home run-ins, lasting two to four days, will occur prior to the pramlintide interventions. The interventions containing pramlintide with the same insulin will occur in sequence, one immediately after the other. The first pramlintide-and-Fiasp intervention will use a ratio of 8μg pramlintide/1unit of insulin and will be followed by the second pramlintide-and-Fiasp intervention the next day with a 10μg/1unit ratio. A similar schedule will be applied to the optional Aspart-and-pramlintide interventions. There will be a 2-29-day washout period between the Fiasp-and-pramlintide, Fiasp-alone, and Aspart-and-pramlintide interventions. Participants will be followed up remotely 1-2 days after the end of each intervention to ensure their washout period is going smoothly and will inquire about any adverse events. Remote contact can be performed via phone, email, text message or other reasonable communication channel. Participants will also be followed up remotely 1-2 days and 1-2 weeks after the end of their participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Randomized, crossover
| Arm | Type | Receives |
|---|---|---|
| Fiasp-and-pramlintide fully automated system (8μg) | Experimental | Drug: Fiasp, Device: Artificial Pancreas, Drug: PramlintideFiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide. |
| Fiasp-alone with carbohydrate-matched boluses | Active comparator | Drug: FiaspThe Fiasp-alone intervention will have a 14 hour duration. During which, carbohydrate counting will inform insulin bolus doses based on insulin to carbohydrate ratios. |
| Aspart-and-pramlintide fully automated system (10μg) | Experimental | Device: Artificial Pancreas, Drug: Pramlintide, Drug: AspartAspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide. |
| Fiasp-and-pramlintide fully automated system (10μg) | Experimental | Drug: Fiasp, Device: Artificial Pancreas, Drug: PramlintideFiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide. |
| Aspart-and-pramlintide fully automated system (8μg) | Experimental | Device: Artificial Pancreas, Drug: Pramlintide, Drug: AspartAspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females and males ≥ 18 years of age.
- Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Use of insulin pump therapy for at least 3 months.
- Effective birth-control use in individuals of childbearing potential. Individuals of child-bearing potential must agree to use a highly effective method of birth control.
Key exclusion criteria (11 listed)
- Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2I (sodium-glucose transporter), GLP-1(glucagon-like peptide), Metformin, etc.).
- Current use of glucocorticoid medication (except low, stable does and inhaled steroids).
- Individuals with confirmed gastroparesis.
- Use of medication that alters gastrointestinal motility.
- Planned or ongoing pregnancy.
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 |
|---|---|---|
| FiaspFiasp Insulin delivered in a basal-bolus manner. | Drug | Fiasp-alone with carbohydrate-matched boluses, Fiasp-and-pramlintide fully automated system (10μg), Fiasp-and-pramlintide fully automated system (8μg) |
| Artificial PancreasMedtronic insulin pump, Dexcom G6 continuous glucose sensor, tablet running the Artificial Pancreas Algorithm. | Device | Aspart-and-pramlintide fully automated system (10μg), Aspart-and-pramlintide fully automated system (8μg), Fiasp-and-pramlintide fully automated system (10μg), Fiasp-and-pramlintide fully automated system (8μg) |
| PramlintidePramlintide delivered in a basal-bolus manner. | Drug | Aspart-and-pramlintide fully automated system (10μg), Aspart-and-pramlintide fully automated system (8μg), Fiasp-and-pramlintide fully automated system (10μg), Fiasp-and-pramlintide fully automated system (8μg) |
| AspartAspart insulin delivered in a basal-bolus manner. | Drug | Aspart-and-pramlintide fully automated system (10μg), Aspart-and-pramlintide fully automated system (8μg) |
Primary outcome
Each participant's percentage of time glucose levels spent in the target range
Time frame: 42 +/- 28 hours
Time in target range (3.9-10.0 mmol/L).
13 secondary outcomes
Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Time frame: 42 +/- 28 hours
Each participant's percentage of time of glucose levels spent below 3.9 mmol/L
Time frame: 42 +/- 28 hours
Each participant's percentage of time of glucose levels spent below 3.0 mmol/L
Time frame: 42 +/- 28 hours
Each participant's percentage of time of glucose levels spent above 10.0 mmol/L
Time frame: 42 +/- 28 hours
Each participant's percentage of time of glucose levels spent above 13.9 mmol/L
Time frame: 42 +/- 28 hours
Each participant's percentage of time of glucose levels spent above 16.7 mmol/L
Time frame: 42 +/- 28 hours
Each participant's mean glucose levels
Time frame: 42 +/- 28 hours
Each participant's standard deviation of glucose levels
Time frame: 42 +/- 28 hours
Each participant's coefficient of variance of glucose levels
Time frame: 42 +/- 28 hours
Total pramlintide delivery for each participant
Time frame: 28 +/- 28 hours
Total insulin delivery for each participant
Time frame: 42 +/- 28 hours
Total basal insulin delivery for each participant
Time frame: 42 +/- 28 hours
Total bolus insulin delivery for each participant
Time frame: 42 +/- 28 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 25 Oct 2023.
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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.
Michael Tsoukas, M.D. principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiasp, Artificial Pancreas and Pramlintide in people with Type 1 Diabetes, 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 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. 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.
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?
Each participant's percentage of time glucose levels spent in the target range (time frame: 42 +/- 28 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 25 Oct 2023.