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Trial · Interventional

CompletedPhase 2Registry data

Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting

Short name Dual

NCTNCT03800875 (opens ClinicalTrials.gov in a new tab)Other idTriple Hormone
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
24 participants (actual)
Sponsor
McGill University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Canada

Start
8 Feb 2019
Primary completion
19 Sept 2020
Completion
19 Sept 2020
First posted
11 Jan 2019
Last update posted
8 Jun 2021
Conditions
Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 2

    Dual

    NCT03800875

    8 Feb 2019 to 19 Sept 2020

Registry summary

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

Closed-loop system systems that are shown to alleviate the burden of carbohydrate counting without degrading glucose control are still lacking. In this proposal, the investigators aim to develop a novel, fully-automated, closed-loop system that delivers insulin and pramlintide that controls postprandial glucose levels without any input from the user.

Interventions

  • 27-hour inpatient interventionDrug

Arms2

  • Experimental

    Insulin-Pramlintide Closed-Loop Strategy

    Fast-acting insulin will be delivered using two separate infusion pumps. The pumps' infusion rates will then be changed manually based on the computer-generated recommendation. The computer-generated recommendations are based on a dosing algorithm. With no-meal announcement or carbohydrate counting, the dual-hormone closed-loop system will be fully reactive, and insulin and pramlintide dosages will be based solely on sensor readings

  • Active comparator

    Insulin-alone Closed Loop Strategy

    Fast-acting insulin will be delivered by a subcutaneous insulin infusion pump based on an algorithm that automatically adjusts insulin rates based on a dosing algorithm. The carbohydrate content for every ingested meal will be entered into the algorithm to calculate the insulin prandial bolus based on each participant's insulin-to-carbohydrate ratio. The carbohydrate content will be entered at the onset of the meal. Drug(s): Insulin (FiAsp)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Total percentage of time (22:00-22:00) that the glucose concentration remained within 3.9 and 10.0 mmol/L

    Time frame · 24 hours

Secondary outcomes(10)

  1. Total percentage of time (22:00-22:00) that the glucose concentration remained within specified ranges.

    Time frame · 24 hours

    Registry description

    a. between 3.9 and 7.8 mmol/L; b. below 3.9 mmol/L; c. between 3.9 and 10 mmol/L d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.

  2. Percentage of overnight time (24:00-8:00) that the glucose concentration remained within specified ranges.

    Time frame · 8 hours

    Registry description

    a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.

  3. Total amount of insulin delivered to the participant

    Time frame · 24 hours

  4. Mean sensor glucose concentration during the overnight stay

    Time frame · 8 hours

  5. Number of participants experiencing hypoglycemia requiring oral treatment during: a. the overall study period; b. the night; c. the day

    Time frame · 27 hours

  6. The number and severity of gastrointestinal sysmptoms experienced by a participant

    Time frame · 27 hours

    Registry description

    GI symptoms include: nausea, vomiting, bloating and heartburn

  7. Mean daytime insulin concentration

    Time frame · 14 hours

  8. Mean daytime concentration of amylin

    Time frame · 14 hours

  9. Total amount of pramlintide delivered to the participant

    Time frame · 24 hours

  10. Mean glucose level

    Time frame · 24-hour period

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 · 2021

4 results

A fully artificial pancreas versus a hybrid artificial pancreas for type 1 diabetes: a single-centre, open-label, randomised controlled, crossover, non-inferiority trial.

Tsoukas et al. 2021The Lancet. Digital healthcited by 37

PMID 34580055DOI 10.1016/s2589-7500(21)00139-4PUB-34580055

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Males and females ≥ 18 years of age. 2. 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. 3. Insulin pump therapy for at least 6 months. 4. HbA1c ≤ 12% in the last 6 months. Exclusion Criteria: 1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc.…). 2. Severe hypoglycemic episode within one month of admission. 3. Severe diabetic ketoacidosis episode within one month of admission. 4. Pregnancy. 5. Known or suspected allergy to the study drugs. 6. Gastroparesis. 7. Use of prokinetic drugs that stimulate gastric emptying (domperidone, cisapride, metoclopramide). 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. Current use of glucocorticoid medication. 11. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. 12. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

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