Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

NCT03993366 | Completed

• 1 other identifier: 2019-4947
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes; artificial pancreas; pramlintide; closed-loop

Outcome Measures

Primary Outcomes (3)

• Time in target

  Time spent in target range (between 4.0 mmol/L and 10 mmol/L)

  24 hours

• Time in hypoglycemia

  Time spent in hypoglycemic range (below 4.0 mmol/L)

  24 hours

• Time in hyperglycemia

  Time spent in hyperglycemic range (above 10.0 mmol/L)

  24 hours

Other Outcomes (4)

• Hypoglycemia treatment

  24 hrs

• Hypoglycemia treatment

  During the night of the 24 hour intervention (11pm-7am)

• Hypoglycemia treatment

  During the day of the 24 hour intervention (7am-11pm)

Study Arms (2)

Simple Meal Announcement

EXPERIMENTAL

Before every meal, the meal will be simply announced to the algorithm by a member of the study team. Meal bolus computation will be independent of the carbohydrate content of the meal.

Combination Product: Fiasp+Pramlintide Closed-Loop System

Full Carbohydrate counting

ACTIVE COMPARATOR

The carbohydrate content of the meal selected by the participant will be entered into the dosing algorithm by a member of the study team at the onset of the meal to compute the insulin prandial bolus.

Device: Fiasp Closed-Loop System

Interventions

Fiasp+Pramlintide Closed-Loop System COMBINATION_PRODUCT

Closed-loop insulin delivery with Fiasp insulin and pramlintide

Simple Meal Announcement

Fiasp Closed-Loop System DEVICE

Closed-loop insulin delivery with Fiasp insulin alone

Full Carbohydrate counting

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 12 years of age.
• Clinical diagnosis of type 1 diabetes for at least 12 months according to the Diabetes Canada Clinical Practice Guidelines Expert Committee diagnostic criteria.
• The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
• Insulin pump therapy for at least 6 months.
• HbA1c ≤ 12%.

You may not qualify if:

• Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 (Sodium-glucose Cotransporter-2), GLP-1 (glucagon-like peptide 1), 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 keto-acidosis 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 hypoglycemia unawareness.
• 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.
• 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

Sponsors & Collaborators

• McGill University: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

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 study is a randomized, 2-way, crossover trial assessing: i. Fiasp-alone closed-loop system with full carbohydrate counting ii. Fiasp-plus-Pramlintide closed-loop system with simple meal announcement in regulating glucose levels in patients with type 1 diabetes, over a period of 24h in an inpatient setting.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: June 20, 2019
• Study Start: March 1, 2019
• Primary Completion: August 6, 2019
• Study Completion: August 6, 2019
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CA (1)