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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163874
• Other study ID #: 2020-5712
• Status: Completed
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: October 2022
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Signed and dated written informed consent

2. Males and females = 12 years of age

3. HbA1c = 12%

4. Insulin pump use for at least 3 months

5. 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.

6. 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:

1. Current or = 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, 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 ketoacidosis 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 confirmed gastroparesis.

12. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

13. Unable to travel to research center within 3h if needed during study interventions

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Fiasp
Fiasp Insulin delivered in a basal-bolus manner.
• Pramlintide Acetate
Pramlintide delivered in a basal-bolus manner with a fixed ratio with insulin.
• Placebo
Placebo delivered in a basal-bolus manner with a fixed ratio with insulin.

Device:
• Artificial Pancreas
Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.

Locations

Country	Name	City	State
Canada	3555 University Street	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Each participant's time in target range	Time in target range (3.9-10mmol/L)	12 days
Primary	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.	12 days
Secondary	Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L		12 days
Secondary	Each participant's percentage of time of glucose levels spent between 3.9 and 10 mmol/L		12 days
Secondary	Each participant's percentage of time of glucose levels spent below 3.9, 3.3, and 2.8 mmol/L		12 days
Secondary	Each participant's percentage of time of glucose levels spent above 7.8, 10, 13.9 and 16.7 mmol/L		12 days
Secondary	Each participant's mean glucose level		12 days
Secondary	Each participant's standard deviation of glucose levels as a measure of glucose variability		12 days
Secondary	Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L		12 days
Secondary	Each participant's number of Gastrointestinal symptoms		12 days
Secondary	Each participant's total insulin delivery		12 days