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Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas

Primary Purpose

Type 1 Diabetes, Type 1 Diabetes Mellitus, Hyperglycemia, Postprandial

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Fiasp

Pramlintide Acetate

Placebo

Artificial Pancreas

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Signed and dated written informed consent
Males and females ≥ 12 years of age
HbA1c ≤ 12%
Insulin pump use for at least 3 months
Clinical diagnosis with type 1 diabetes for at least 12 months. The diagnosis of T1D is based on the investigator's clinical judgment; C peptide level and antibody determinations are not planned.
Women of child-bearing potential must be ready and able to use a highly effective method of birth control. Women of childbearing potential are females who have experienced [the first occurrence of menstruation] and do not meet the criteria for women not of childbearing potential. Women not of childbearing potential are females who are permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

Exclusion Criteria:

Participants who meet any of the following criteria are not eligible for the study:

Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, 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 ketoacidosis 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 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.
Unable to travel to research center within 3h if needed during study interventions
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.

Sites / Locations

3555 University Street

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Fiasp-plus-Placebo with Full Carbohydrate Counting

Fiasp-plus-placebo with Simple Meal Announcement

Fiasp-plus-Pramlintide with Simple Meal Announcement

Arm Description

Fiasp insulin and placebo insulin infusion in two insulin pumps with full carbohydrate counting.

Fiasp insulin and placebo (saline) insulin infusion in two insulin pumps using the simple meal announcement system.

Fiasp insulin and pramlintide insulin infusion in two insulin pumps using the simple meal announcement system.

Outcomes

Primary Outcome Measures

Each participant's time in target range

Time in target range (3.9-10mmol/L)

Mean score of the Emotional Burden section of the Diabetes Distress Scale

Average of all question's scores (from 1-6). Higher score means more emotional burden.

Secondary Outcome Measures

Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L

Each participant's percentage of time of glucose levels spent between 3.9 and 10 mmol/L

Each participant's percentage of time of glucose levels spent below 3.9, 3.3, and 2.8 mmol/L

Each participant's percentage of time of glucose levels spent above 7.8, 10, 13.9 and 16.7 mmol/L

Each participant's mean glucose level

Each participant's standard deviation of glucose levels as a measure of glucose variability

Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L

Each participant's number of Gastrointestinal symptoms

Each participant's total insulin delivery

Full Information

NCT ID

NCT04163874

First Posted

August 26, 2019

Last Updated

October 6, 2022

Sponsor

McGill University

Collaborators

Juvenile Diabetes Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04163874

Brief Title

Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas

Official Title

Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas: a Randomized Controlled Crossover Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

February 14, 2020 (Actual)

Primary Completion Date

January 30, 2022 (Actual)

Study Completion Date

January 30, 2022 (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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes. Amylin, in the postprandial period, contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion, and increasing satiety. Pramlintide is a synthetic analog of the hormone amylin. A closed-loop system that delivers both insulin and pramlintide, based on glucose sensor readings, has the potential to better normalize glucose levels, especially during the post-prandial period. The aim of this project is to assess whether co-administration of pramlintide with the improved insulin aspart formulation - Fiasp, in an artificial pancreas system, will alleviate the need for carb counting by replacing it with a simple meal announcement, without degrading the quality of glycemic control in a closed-loop therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes, Type 1 Diabetes Mellitus, Hyperglycemia, Postprandial

Keywords

type 1 diabetes, artificial pancreas, pramlintide, fiasp, hyperglycemia, closed-loop

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This is a three-way, randomized, blinded, crossover trial to compare the following strategies: (i) Fiasp-plus-Pramlintide closed-loop delivery with a simple meal announcement (pressing a button, no carbohydrate counting) (ii) Fiasp-plus-placebo closed-loop delivery with conventional carbohydrate counting (iii) Fiasp-plus-placebo closed-loop delivery with a simple meal announcement

Masking

ParticipantCare ProviderInvestigator

Masking Description

This study will be a double-blinded study, where the participants and researchers will be blinded to the study drugs. Participants will wear two pumps for all interventions, one for insulin and the other for pramlintide/placebo (saline solution).

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fiasp-plus-Placebo with Full Carbohydrate Counting

Arm Type

Experimental

Arm Description

Fiasp insulin and placebo insulin infusion in two insulin pumps with full carbohydrate counting.

Arm Title

Fiasp-plus-placebo with Simple Meal Announcement

Arm Type

Placebo Comparator

Arm Description

Fiasp insulin and placebo (saline) insulin infusion in two insulin pumps using the simple meal announcement system.

Arm Title

Fiasp-plus-Pramlintide with Simple Meal Announcement

Arm Type

Active Comparator

Arm Description

Fiasp insulin and pramlintide insulin infusion in two insulin pumps using the simple meal announcement system.

Intervention Type

Drug

Intervention Name(s)

Fiasp

Intervention Description

Fiasp Insulin delivered in a basal-bolus manner.

Intervention Type

Drug

Intervention Name(s)

Pramlintide Acetate

Intervention Description

Pramlintide delivered in a basal-bolus manner with a fixed ratio with insulin.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo delivered in a basal-bolus manner with a fixed ratio with insulin.

Intervention Type

Device

Intervention Name(s)

Artificial Pancreas

Intervention Description

Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.

Primary Outcome Measure Information:

Title

Each participant's time in target range

Description

Time in target range (3.9-10mmol/L)

Time Frame

12 days

Title

Mean score of the Emotional Burden section of the Diabetes Distress Scale

Description

Average of all question's scores (from 1-6). Higher score means more emotional burden.

Time Frame

12 days

Secondary Outcome Measure Information:

Title

Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L

Time Frame

12 days

Title

Each participant's percentage of time of glucose levels spent between 3.9 and 10 mmol/L

Time Frame

12 days

Title

Each participant's percentage of time of glucose levels spent below 3.9, 3.3, and 2.8 mmol/L

Time Frame

12 days

Title

Each participant's percentage of time of glucose levels spent above 7.8, 10, 13.9 and 16.7 mmol/L

Time Frame

12 days

Title

Each participant's mean glucose level

Time Frame

12 days

Title

Each participant's standard deviation of glucose levels as a measure of glucose variability

Time Frame

12 days

Title

Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L

Time Frame

12 days

Title

Each participant's number of Gastrointestinal symptoms

Time Frame

12 days

Title

Each participant's total insulin delivery

Time Frame

12 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed and dated written informed consent Males and females ≥ 12 years of age HbA1c ≤ 12% Insulin pump use for at least 3 months Clinical diagnosis with type 1 diabetes for at least 12 months. The diagnosis of T1D is based on the investigator's clinical judgment; C peptide level and antibody determinations are not planned. Women of child-bearing potential must be ready and able to use a highly effective method of birth control. Women of childbearing potential are females who have experienced [the first occurrence of menstruation] and do not meet the criteria for women not of childbearing potential. Women not of childbearing potential are females who are permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Exclusion Criteria: Participants who meet any of the following criteria are not eligible for the study: Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, 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 ketoacidosis 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 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. Unable to travel to research center within 3h if needed during study interventions 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

3555 University Street

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 2B1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The raw data (i.e., insulin delivery, glucose levels, individual participant data) and informed consent form could be shared by the corresponding author, ahmad.haidar@mcgill.ca, upon reasonable request for academic purposes, subject to Material Transfer Agreement and approval of McGill University Health Center's Research Ethics Board. All data shared will be deidentified. Study protocol is available with publication.

Learn more about this trial

Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas

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