search
Back to results

Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fiasp+Pramlintide Closed-Loop System
Fiasp Closed-Loop System
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes, artificial pancreas, pramlintide, closed-loop

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McGill University Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simple Meal Announcement

Full Carbohydrate counting

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time in target
Time spent in target range (between 4.0 mmol/L and 10 mmol/L)
Time in hypoglycemia
Time spent in hypoglycemic range (below 4.0 mmol/L)
Time in hyperglycemia
Time spent in hyperglycemic range (above 10.0 mmol/L)

Secondary Outcome Measures

Full Information

First Posted
March 11, 2019
Last Updated
March 31, 2021
Sponsor
McGill University
Collaborators
Juvenile Diabetes Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT03993366
Brief Title
Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement
Official Title
A Preliminary Pilot Study to Assess Insulin-plus-Pramlintide Closed-loop Delivery System in Pump Treated Patients With Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 6, 2019 (Actual)
Study Completion Date
August 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McGill University
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
type 1 diabetes, artificial pancreas, pramlintide, closed-loop

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simple Meal Announcement
Arm Type
Experimental
Arm Description
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.
Arm Title
Full Carbohydrate counting
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Fiasp+Pramlintide Closed-Loop System
Intervention Description
Closed-loop insulin delivery with Fiasp insulin and pramlintide
Intervention Type
Device
Intervention Name(s)
Fiasp Closed-Loop System
Intervention Description
Closed-loop insulin delivery with Fiasp insulin alone
Primary Outcome Measure Information:
Title
Time in target
Description
Time spent in target range (between 4.0 mmol/L and 10 mmol/L)
Time Frame
24 hours
Title
Time in hypoglycemia
Description
Time spent in hypoglycemic range (below 4.0 mmol/L)
Time Frame
24 hours
Title
Time in hyperglycemia
Description
Time spent in hyperglycemic range (above 10.0 mmol/L)
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Hypoglycemia treatment
Description
Number of participants experiencing hypoglycemia requiring oral treatment
Time Frame
24 hrs
Title
Hypoglycemia treatment
Description
Number of participants experiencing hypoglycemia requiring oral treatment
Time Frame
During the night of the 24 hour intervention (11pm-7am)
Title
Hypoglycemia treatment
Description
Number of participants experiencing hypoglycemia requiring oral treatment
Time Frame
During the day of the 24 hour intervention (7am-11pm)
Title
Gastrointestinal symptoms
Description
Presence of gastrointestinal symptoms
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

We'll reach out to this number within 24 hrs