A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes

NCT05199714 | Completed

• 1 other identifier: 2022-8225
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to assess the glycemic outcomes of a fully automated insulin-and-pramlintide artificial pancreas and a comparator insulin-alone artificial pancreas with carbohydrate matched boluses.

Conditions

Type 1 Diabetes

Keywords

Artificial Pancreas; Insulin; Pramlintide; Aspart; Fiasp

Outcome Measures

Primary Outcomes (1)

• Each participant's percentage of time glucose levels spent in the target range

  Time in target range (3.9-10.0 mmol/L).

  42 +/- 28 hours

Secondary Outcomes (13)

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

  42 +/- 28 hours

• Each participant's percentage of time of glucose levels spent below 3.9 mmol/L

  42 +/- 28 hours

• Each participant's percentage of time of glucose levels spent below 3.0 mmol/L

  42 +/- 28 hours

• Each participant's percentage of time of glucose levels spent above 10.0 mmol/L

  42 +/- 28 hours

• Each participant's percentage of time of glucose levels spent above 13.9 mmol/L

  42 +/- 28 hours

Other Outcomes (1)

• Safety Endpoints

  42 +/- 28 hours

Study Arms (5)

Fiasp-and-pramlintide fully automated system (8μg)

EXPERIMENTAL

Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.

Drug: Fiasp; Device: Artificial Pancreas; Drug: Pramlintide

Fiasp-alone with carbohydrate-matched boluses

ACTIVE COMPARATOR

The Fiasp-alone intervention will have a 14 hour duration. During which, carbohydrate counting will inform insulin bolus doses based on insulin to carbohydrate ratios.

Drug: Fiasp

Aspart-and-pramlintide fully automated system (10μg)

EXPERIMENTAL

Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.

Device: Artificial Pancreas; Drug: Pramlintide; Drug: Aspart

Fiasp-and-pramlintide fully automated system (10μg)

EXPERIMENTAL

Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.

Drug: Fiasp; Device: Artificial Pancreas; Drug: Pramlintide

Aspart-and-pramlintide fully automated system (8μg)

EXPERIMENTAL

Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.

Device: Artificial Pancreas; Drug: Pramlintide; Drug: Aspart

Interventions

Fiasp DRUG

Fiasp Insulin delivered in a basal-bolus manner.

Fiasp-alone with carbohydrate-matched boluses; Fiasp-and-pramlintide fully automated system (10μg); Fiasp-and-pramlintide fully automated system (8μg)

Artificial Pancreas DEVICE

Medtronic insulin pump, Dexcom G6 continuous glucose sensor, tablet running the Artificial Pancreas Algorithm.

Aspart-and-pramlintide fully automated system (10μg); Aspart-and-pramlintide fully automated system (8μg); Fiasp-and-pramlintide fully automated system (10μg); Fiasp-and-pramlintide fully automated system (8μg)

Pramlintide DRUG

Pramlintide delivered in a basal-bolus manner.

Aspart-and-pramlintide fully automated system (10μg); Aspart-and-pramlintide fully automated system (8μg); Fiasp-and-pramlintide fully automated system (10μg); Fiasp-and-pramlintide fully automated system (8μg)

Aspart DRUG

Aspart insulin delivered in a basal-bolus manner.

Aspart-and-pramlintide fully automated system (10μg); Aspart-and-pramlintide fully automated system (8μg)

Eligibility Criteria

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

You may qualify if:

• Females and males ≥ 18 years of age.
• 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.
• Use of insulin pump therapy for at least 3 months.
• Effective birth-control use in individuals of childbearing potential. Individuals of child-bearing potential must agree to use a highly effective method of birth control.

You may not qualify if:

• Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2I (sodium-glucose transporter), GLP-1(glucagon-like peptide), Metformin, etc.).
• Current use of glucocorticoid medication (except low, stable does and inhaled steroids).
• Individuals with confirmed gastroparesis.
• Use of medication that alters gastrointestinal motility.
• Planned or ongoing pregnancy.
• Breastfeeding individuals.
• Severe hypoglycemia requiring hospitalization in the past three months.
• Severe diabetic ketoacidosis episode in the past three months.
• 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.
• Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Research Institute of the McGill University Health Center

Montreal, Quebec, H4A 3T2, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Insulin Aspart; Pancreas, Artificial; pramlintide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; 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

Study Officials

• Michael Tsoukas, M.D.

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michael Tsoukas M.D., Principal Investigator, Assistant Professor, Endocrinology & Metabolism, McGill University Health Centre/Research Institute of the McGill University Health Centre

Model Details: Randomized, crossover

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 20, 2022
• Study Start: February 21, 2022
• Primary Completion: March 25, 2023
• Study Completion: March 25, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

CA (1)