Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

Study Overview
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Brief Summary
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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

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Combination Product: Fiasp+Pramlintide Closed-Loop System
* Device: Fiasp Closed-Loop System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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%. Exclusion Criteria: 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 Failure to comply with the protocol. Pregnancy. After an event which the PI believes it is not in the best interest for the patient to continue the trial.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simple Meal Announcement<br>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<br>* Closed-loop insulin delivery with Fiasp insulin and pramlintide<br>|
| Active Comparator: Full Carbohydrate counting<br>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<br>* Closed-loop insulin delivery with Fiasp insulin alone<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, artificial pancreas, pramlintide, closed-loop