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Trial · Interventional

CompletedNot applicableRegistry data

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

NCTNCT04163874 (opens ClinicalTrials.gov in a new tab)Other id2020-5712
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
36 participants (actual)
Sponsor
McGill University · Other
Design
Randomized · Triple masking
Countries
1 country

Canada

Start
14 Feb 2020
Primary completion
30 Jan 2022
Completion
30 Jan 2022
First posted
15 Nov 2019
Last update posted
10 Oct 2022
Conditions
Type 1 Diabetes · Type 1 Diabetes Mellitus · Hyperglycemia, Postprandial

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023
  1. N/A

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

    NCT04163874

    14 Feb 2020 to 30 Jan 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • FiaspDrug
  • Pramlintide AcetateDrug
  • PlaceboDrug
  • Artificial PancreasDevice

Arms3

  • Experimental

    Fiasp-plus-Placebo with Full Carbohydrate Counting

    Fiasp insulin and placebo insulin infusion in two insulin pumps with full carbohydrate counting.

  • Placebo comparator

    Fiasp-plus-placebo with Simple Meal Announcement

    Fiasp insulin and placebo (saline) insulin infusion in two insulin pumps using the simple meal announcement system.

  • Active comparator

    Fiasp-plus-Pramlintide with Simple Meal Announcement

    Fiasp insulin and pramlintide insulin infusion in two insulin pumps using the simple meal announcement system.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Each participant's time in target range

    Time frame · 12 days

    Registry description

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

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

    Time frame · 12 days

    Registry description

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

Secondary outcomes(9)

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

    Time frame · 12 days

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

    Time frame · 12 days

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

    Time frame · 12 days

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

    Time frame · 12 days

  5. Each participant's mean glucose level

    Time frame · 12 days

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

    Time frame · 12 days

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

    Time frame · 12 days

  8. Each participant's number of Gastrointestinal symptoms

    Time frame · 12 days

  9. Each participant's total insulin delivery

    Time frame · 12 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

5 results

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.

Cohen et al. 2024The Lancet. Digital healthcited by 16

PMID 38906614DOI 10.1016/s2589-7500(24)00092-xPUB-38906614

Full text at the publisher5 results
Publisher pageSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Signed and dated written informed consent 2. Males and females ≥ 12 years of age 3. HbA1c ≤ 12% 4. Insulin pump use for at least 3 months 5. 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. 6. 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. Exclusion Criteria: Participants who meet any of the following criteria are not eligible for the study: 1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, Metformin, Acarbose, etc.…). 2. Current use of glucocorticoid medication. 3. Use of medication that alters gastrointestinal motility. 4. Planned or ongoing pregnancy. 5. Breastfeeding individuals. 6. Severe hypoglycemic episode within one month of admission. 7. Severe diabetes ketoacidosis episode within one month of admission. 8. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. 9. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. 10. Known hypersensitivity to any of the study drugs or their excipients. 11. Individuals with confirmed gastroparesis. 12. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. 13. Unable to travel to research center within 3h if needed during study interventions 14. 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 1. Failure to comply with the protocol. 2. Pregnancy. 3. After an event which the PI believes it is not in the best interest for the patient to continue the trial.

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