Type 1 Diabetes MellitusNCT03993366
Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement
A study testing Fiasp+Pramlintide Closed-Loop System and Fiasp Closed-Loop System in people with Type 1 Diabetes Mellitus, run by McGill University at 1 site in Canada.
Trial summary
The aim of this pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Fiasp+Pramlintide Closed-Loop System and Fiasp Closed-Loop System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 6 Aug 2019
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females ≥ 12 years of age.
- Clinical diagnosis of type 1 diabetes for at least 12 months according to the Diabetes Canada Clinical Practice Guidelines Expert Committee diagnostic criteria.
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Insulin pump therapy for at least 6 months.
- HbA1c ≤ 12%.
Who cannot join
- Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 (Sodium-glucose Cotransporter-2), GLP-1 (glucagon-like peptide 1), Metformin, Acarbose, etc.…).
- Current use of glucocorticoid medication.
- Use of medication that alters gastrointestinal motility.
- Planned or ongoing pregnancy.
- Breastfeeding individuals.
- Severe hypoglycemic episode within one month of admission.
Show all 18Show fewer
- Severe diabetes keto-acidosis episode within one month of admission.
- 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.
- Known hypersensitivity to any of the study drugs or their excipients.
- Individuals with hypoglycemia unawareness.
- Individuals with confirmed gastroparesis.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
- Study Discontinuation/Withdrawal
- Failure to comply with the protocol.
- Pregnancy.
- After an event which the PI believes it is not in the best interest for the patient to continue the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Preliminary Pilot Study to Assess Insulin-plus-Pramlintide Closed-loop Delivery System in Pump Treated Patients With Type 1 Diabetes Mellitus
The aim of this pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Fiasp+Pramlintide Closed-Loop System, Fiasp Closed-Loop System
- Keywords
- type 1 diabetes, artificial pancreas, pramlintide, closed-loop
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiasp+Pramlintide Closed-Loop SystemCombination product
Closed-loop insulin delivery with Fiasp insulin and pramlintide
Fiasp Closed-Loop SystemDevice
Closed-loop insulin delivery with Fiasp insulin alone
| Study group | Role | What they receive |
|---|---|---|
| Simple Meal Announcement | Experimental | Before every meal, the meal will be simply announced to the algorithm by a member of the study team. Meal bolus computation will be independent of the carbohydrate content of the meal. Receives: Combination Product: Fiasp+Pramlintide Closed-Loop System |
| Full Carbohydrate counting | Active comparator | The carbohydrate content of the meal selected by the participant will be entered into the dosing algorithm by a member of the study team at the onset of the meal to compute the insulin prandial bolus. Receives: Device: Fiasp Closed-Loop System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in target
Time spent in target range (between 4.0 mmol/L and 10 mmol/L)
Measured: 24 hours
Time in hypoglycemia
Time spent in hypoglycemic range (below 4.0 mmol/L)
Measured: 24 hours
Time in hyperglycemia
Time spent in hyperglycemic range (above 10.0 mmol/L)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Mar 2019
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a randomized, 2-way, crossover trial assessing: i. Fiasp-alone closed-loop system with full carbohydrate counting ii. Fiasp-plus-Pramlintide closed-loop system with simple meal announcement in regulating glucose levels in patients with type 1 diabetes, over a period of 24h in an inpatient setting.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993366
- Sponsor's protocol ID
- 2019-4947
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Pilot Study to Assess Insulin-plus-Pramlintide Closed-loop Delivery System in Pump Treated Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03993366
- Acronym / sponsor ID
- 2019-4947
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes, artificial pancreas, pramlintide, closed-loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 20 Jun 2019 (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 pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized, 2-way, crossover trial assessing: i. Fiasp-alone closed-loop system with full carbohydrate counting ii. Fiasp-plus-Pramlintide closed-loop system with simple meal announcement in regulating glucose levels in patients with type 1 diabetes, over a period of 24h in an inpatient setting.
| Arm | Type | Receives |
|---|---|---|
| Simple Meal Announcement | Experimental | Combination Product: Fiasp+Pramlintide Closed-Loop SystemBefore every meal, the meal will be simply announced to the algorithm by a member of the study team. Meal bolus computation will be independent of the carbohydrate content of the meal. |
| Full Carbohydrate counting | Active comparator | Device: Fiasp Closed-Loop SystemThe carbohydrate content of the meal selected by the participant will be entered into the dosing algorithm by a member of the study team at the onset of the meal to compute the insulin prandial bolus. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ≥ 12 years of age.
- Clinical diagnosis of type 1 diabetes for at least 12 months according to the Diabetes Canada Clinical Practice Guidelines Expert Committee diagnostic criteria.
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Insulin pump therapy for at least 6 months.
- HbA1c ≤ 12%.
Key exclusion criteria (18 listed)
- Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 (Sodium-glucose Cotransporter-2), GLP-1 (glucagon-like peptide 1), Metformin, Acarbose, etc.…).
- Current use of glucocorticoid medication.
- Use of medication that alters gastrointestinal motility.
- Planned or ongoing pregnancy.
- Breastfeeding individuals.
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 |
|---|---|---|
| Fiasp+Pramlintide Closed-Loop SystemClosed-loop insulin delivery with Fiasp insulin and pramlintide | Combination product | Simple Meal Announcement |
| Fiasp Closed-Loop SystemClosed-loop insulin delivery with Fiasp insulin alone | Device | Full Carbohydrate counting |
Primary outcome
Time in target
Time frame: 24 hours
Time spent in target range (between 4.0 mmol/L and 10 mmol/L)
Time in hypoglycemia
Time frame: 24 hours
Time spent in hypoglycemic range (below 4.0 mmol/L)
Time in hyperglycemia
Time frame: 24 hours
Time spent in hyperglycemic range (above 10.0 mmol/L)
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 1 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
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+Pramlintide Closed-Loop System and Fiasp Closed-Loop System in people with Type 1 Diabetes Mellitus, run by McGill University 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 18 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 1 Apr 2021. 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?
Time in target (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 1 Apr 2021.