Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System in Adults With Type 1 Diabetes

NCT04243629 | Unknown

• 1 other identifier: 2020-6258
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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 rapid insulin in an artificial pancreas system will improve glycemic control in adults with Type 1 Diabetes.

Conditions

Diabetes Mellitus, Type 1; Type 1 Diabetes; Postprandial Hyperglycemia

Keywords

Artificial pancreas; Closed-loop system; Amylin; Pramlintide; Type 1 Diabetes; Glycemic control

Outcome Measures

Primary Outcomes (1)

• Time in target range

  Time each participant spent with glucose level in target range (3.9 - 10.0 mmol/L)

  4 weeks

Secondary Outcomes (8)

• Time between 3.9 - 7.8 mmol/L

  4 weeks

• Time below 3,9, 3.3, and 2.8 mmol/L

  4 weeks

• Time above 7.8, 10.0, 13.9, 16.7 mmol/L

  4 weeks

• Mean glucose level

  4 weeks

• Total insulin delivery

  4 weeks

Study Arms (2)

Rapid Insulin-Plus-Pramlintide

EXPERIMENTAL

Rapid insulin and pramlintide infusion in two insulin pumps

Drug: Rapid-Acting Insulin; Drug: Pramlintide Acetate; Device: Artificial Pancreas

Rapid Insulin-Plus-Placebo

PLACEBO COMPARATOR

Rapid insulin and placebo (saline) infusion in two insulin pumps

Drug: Rapid-Acting Insulin; Drug: Placebo; Device: Artificial Pancreas

Interventions

Rapid-Acting Insulin DRUG

Novorapid or Humalog insulin delivered in a basal-bolus manner.

Rapid Insulin-Plus-Placebo; Rapid Insulin-Plus-Pramlintide

Placebo DRUG

Placebo (saline) delivered in a basal-bolus manner at a fixed ratio with insulin.

Rapid Insulin-Plus-Placebo

Pramlintide Acetate DRUG

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

Rapid Insulin-Plus-Pramlintide

Artificial Pancreas DEVICE

Tandem insulin pump, Dexcom G6 sensor, study smartphone running the iMAP algorithm.

Rapid Insulin-Plus-Placebo; Rapid Insulin-Plus-Pramlintide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent
• Males and females ≥ 18 years of age
• HbA1c ≤ 11% (this is so we also include patient that are potentially missing some meal boluses)
• Insulin pump use for at least 6 months and actively performing carbohydrate counting
• Clinical diagnosis of 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.

You may not qualify if:

• Current total daily dose \< 0.4 units/kg (we wish to exclude participants who would still be considered in honeymoon period).
• Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, Metformin, Acarbose, etc.…).
• Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
• Anticipated need to use acetaminophen during study participation
• Use of medication that alters gastrointestinal motility.
• Planned or ongoing pregnancy.
• Breastfeeding individuals.
• Severe hypoglycemic episode within 3 months of admission.
• Severe diabetes ketoacidosis episode within 3 months 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.
• In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study devices.

Sponsors & Collaborators

• McGill University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia

Interventions

Insulin, Short-Acting; pramlintide; Pancreas, Artificial

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Artificial Organs; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Elisa Cohen, BSs

CONTACT

6472372366; elisa.cohen@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-way, randomized, open-label, controlled, crossover trial to compare the following strategies: (i) Rapid insulin-plus-Pramlintide closed-loop delivery (ii) Rapid insulin-plus-Placebo closed-loop delivery

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: November 12, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CA (1)