Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

A Preliminary Pilot Study to Assess Insulin-plus-Pramlintide Closed-loop Delivery System in Pump Treated Patients With Type 1 Diabetes Mellitus

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Combination product: Fiasp+Pramlintide Closed-Loop System; Device: Fiasp Closed-Loop System

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • McGill University Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 (Sodium-glucose Cotransporter-2), GLP-1 (glucagon-like peptide 1), Metformin, Acarbose, etc.…).
2. Current use of glucocorticoid medication.
3. Use of medication that alters gastrointestinal motility.
4. Planned or ongoing pregnancy.
5. Breastfeeding individuals.
6. Severe hypoglycemic episode within one month of admission.
7. Severe diabetes keto-acidosis episode within one month of admission.
8. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
9. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
10. Known hypersensitivity to any of the study drugs or their excipients.
11. Individuals with hypoglycemia unawareness.
12. Individuals with confirmed gastroparesis.
13. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
14. 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

1. Failure to comply with the protocol.
2. Pregnancy.
3. After an event which the PI believes it is not in the best interest for the patient to continue the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Simple Meal Announcement; 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; Closed-loop insulin delivery with Fiasp insulin and pramlintide
ACTIVE_COMPARATOR: Full Carbohydrate counting; 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; Closed-loop insulin delivery with Fiasp insulin alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoglycemia treatment	Number of participants experiencing hypoglycemia requiring oral treatment	24 hrs
Hypoglycemia treatment	Number of participants experiencing hypoglycemia requiring oral treatment	During the night of the 24 hour intervention (11pm-7am)
Hypoglycemia treatment	Number of participants experiencing hypoglycemia requiring oral treatment	During the day of the 24 hour intervention (7am-11pm)
Gastrointestinal symptoms	Presence of gastrointestinal symptoms	24 hours

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: Juvenile Diabetes Research Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): August 6, 2019
• Study Completion (ACTUAL): August 6, 2019

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (ACTUAL): June 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: artificial pancreas; closed-loop; type 1 diabetes; pramlintide
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Aspart; Pramlintide
• Other Study ID Numbers: 2019-4947

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No