AzTrials
AzTrials

Type 1 DiabetesNCT04163874

Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas

A study testing Fiasp, Pramlintide Acetate and Artificial Pancreas in people with Type 1 Diabetes and Type 1 Diabetes Mellitus, run by McGill University 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
Search all trials

Trial summary

One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes. Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Fiasp, Pramlintide Acetate and Artificial Pancreas
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteCanada
Study dates
14 Feb 2020to 30 Jan 2022
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

  • Signed and dated written informed consent
  • Males and females ≥ 12 years of age
  • HbA1c ≤ 12%
  • Insulin pump use for at least 3 months
  • Clinical diagnosis with type 1 diabetes for at least 12 months. The diagnosis of T1D is based on the investigator's clinical judgment; C peptide level and antibody determinations are not planned.
  • Women of child-bearing potential must be ready and able to use a highly effective method of birth control. Women of childbearing potential are females who have experienced [the first occurrence of menstruation] and do not meet the criteria for women not of childbearing potential. Women not of childbearing potential are females who are permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

Who cannot join

  • Participants who meet any of the following criteria are not eligible for the study:
  • Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, Metformin, Acarbose, etc.…).
  • Current use of glucocorticoid medication.
  • Use of medication that alters gastrointestinal motility.
  • Planned or ongoing pregnancy.
  • Breastfeeding individuals.
Show all 19Show fewer
  • Severe hypoglycemic episode within one month of admission.
  • Severe diabetes ketoacidosis 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 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.
  • Unable to travel to research center within 3h if needed during study interventions
  • 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.

Canada1 site

  • 3555 University Street

    Montreal, Quebec, H3A 2B1

Other trials in Canada

About this study

Official title: Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas: a Randomized Controlled Crossover Trial.

One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes. Amylin, in the postprandial period, contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion, and increasing satiety. Pramlintide is a synthetic analog of the hormone amylin. A closed-loop system that delivers both insulin and pramlintide, based on glucose sensor readings, has the potential to better normalize glucose levels, especially during the post-prandial period.

The aim of this project is to assess whether co-administration of pramlintide with the improved insulin aspart formulation - Fiasp, in an artificial pancreas system, will alleviate the need for carb counting by replacing it with a simple meal announcement, without degrading the quality of glycemic control in a closed-loop therapy.

Being tested
Fiasp, Pramlintide Acetate, Placebo, Artificial Pancreas
Keywords
type 1 diabetes, artificial pancreas, pramlintide, fiasp, hyperglycemia, closed-loop
Medical subject headings
Diabetes Mellitus, Type 1, Hyperglycemia

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.

  • Pramlintide AcetateDrug

    Pramlintide delivered in a basal-bolus manner with a fixed ratio with insulin.

  • PlaceboDrug

    Placebo delivered in a basal-bolus manner with a fixed ratio with insulin.

  • Artificial PancreasDevice

    Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.

Study groups in NCT04163874
Study groupRoleWhat they receive
Fiasp-plus-Placebo with Full Carbohydrate CountingExperimentalFiasp insulin and placebo insulin infusion in two insulin pumps with full carbohydrate counting.
Receives: Drug: Fiasp; Drug: Placebo; Device: Artificial Pancreas
Fiasp-plus-placebo with Simple Meal AnnouncementPlacebo comparatorFiasp insulin and placebo (saline) insulin infusion in two insulin pumps using the simple meal announcement system.
Receives: Drug: Fiasp; Drug: Placebo; Device: Artificial Pancreas
Fiasp-plus-Pramlintide with Simple Meal AnnouncementActive comparatorFiasp insulin and pramlintide insulin infusion in two insulin pumps using the simple meal announcement system.
Receives: Drug: Fiasp; Drug: Pramlintide Acetate; Device: Artificial Pancreas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Each participant's time in target range

    Time in target range (3.9-10mmol/L)

    Measured: 12 days

  2. Mean score of the Emotional Burden section of the Diabetes Distress Scale

    Average of all question's scores (from 1-6). Higher score means more emotional burden.

    Measured: 12 days

Secondary outcomes (9)

  1. Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L

    Measured: 12 days

  2. Each participant's percentage of time of glucose levels spent between 3.9 and 10 mmol/L

    Measured: 12 days

  3. Each participant's percentage of time of glucose levels spent below 3.9, 3.3, and 2.8 mmol/L

    Measured: 12 days

  4. Each participant's percentage of time of glucose levels spent above 7.8, 10, 13.9 and 16.7 mmol/L

    Measured: 12 days

  5. Each participant's mean glucose level

    Measured: 12 days

  6. Each participant's standard deviation of glucose levels as a measure of glucose variability

    Measured: 12 days

  7. Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L

    Measured: 12 days

  8. Each participant's number of Gastrointestinal symptoms

    Measured: 12 days

  9. Each participant's total insulin delivery

    Measured: 12 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2019
  2. Study start14 Feb 2020
  3. Primary completion30 Jan 2022
  4. Study completion30 Jan 2022

Resources

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 is a three-way, randomized, blinded, crossover trial to compare the following strategies: (i) Fiasp-plus-Pramlintide closed-loop delivery with a simple meal announcement (pressing a button, no carbohydrate counting) (ii) Fiasp-plus-placebo closed-loop delivery with conventional carbohydrate counting (iii) Fiasp-plus-placebo closed-loop delivery with a simple meal announcement
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04163874
Sponsor's protocol ID
2020-5712
Status last verified
Oct 2022
First submitted
26 Aug 2019
Last updated
10 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The raw data (i.e., insulin delivery, glucose levels, individual participant data) and informed consent form could be shared by the corresponding author, ahmad.haidar@mcgill.ca, upon reasonable request for academic purposes, subject to Material Transfer Agreement and approval of McGill University Health Center's Research Ethics Board. All data shared will be deidentified. Study protocol is available with publication.

Publications

  • Cohen E, Tsoukas MA, Legault L, Vallis M, Von Oettingen JE, Palisaitis E, Odabassian M, Yale JF, Garfield N, Gouchie-Provencher N, Rutkowski J, Jafar A, Ghanbari M, Haidar A. Simple meal announcements and pramlintide delivery versus carbohydrate counting in type 1 diabetes with automated fast-acting insulin aspart delivery: a randomised crossover trial in Montreal, Canada. Lancet Digit Health. 2024 Jul;6(7):e489-e499. doi: 10.1016/S2589-7500(24)00092-X.

    PubMed 38906614

Questions about this trial

What is this clinical trial studying?

A study testing Fiasp, Pramlintide Acetate and Artificial Pancreas in people with Type 1 Diabetes and 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 6 inclusion and 19 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 Oct 2022. 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. Some participants in this study may receive a placebo. 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 time in target range (time frame: 12 days). The study lists 2 primary outcomes in all. 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 NCT04163874, which also lists 1 linked publication.

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 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in