Clinical trial

A Randomized, Controlled, Crossover Pilot Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Artificial Pancreas Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes

NCT05199714

Name

2022-8225

Description

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.

Trial arms

Trial start

2022-02-21

Estimated PCD

2023-03-25

Trial end

2023-03-25

Status

Completed

Treatment

Fiasp

Fiasp Insulin delivered in a basal-bolus manner.

Arms:

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

Artificial Pancreas

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

Arms:

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

Pramlintide delivered in a basal-bolus manner.

Arms:

Aspart

Aspart insulin delivered in a basal-bolus manner.

Arms:

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

Size

Primary endpoint

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

42 +/- 28 hours

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, crossover', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

Updated at

2023-10-25

1 organization

3 products

1 indication

Organization

McGill University Health Centre

Product

Indication

Product

Product