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Completed

NCT Number: NCT04163874

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hyperglycemia, Postprandial Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes Mellitus

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

3555 University Street

Montreal, Quebec, H3A 2B1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.
  • 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.

Treatment and study plan

Fiasp

Drug

Fiasp Insulin delivered in a basal-bolus manner.

Pramlintide acetate

Drug

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

Placebo

Drug

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

Artificial Pancreas

Device

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

Primary outcomes

  1. Each participant's time in target range

    Time frame: 12 days

    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

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2019
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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