Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993366
• Other study ID #: 2019-4947
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 6, 2019

Study information

• Verified date: March 2021
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 6, 2019
• Est. primary completion date: August 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Combination Product:
• Fiasp+Pramlintide Closed-Loop System
Closed-loop insulin delivery with Fiasp insulin and pramlintide

Device:
• Fiasp Closed-Loop System
Closed-loop insulin delivery with Fiasp insulin alone

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montréal	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
Other	Hypoglycemia treatment	Number of participants experiencing hypoglycemia requiring oral treatment	24 hrs
Other	Hypoglycemia treatment	Number of participants experiencing hypoglycemia requiring oral treatment	During the night of the 24 hour intervention (11pm-7am)
Other	Hypoglycemia treatment	Number of participants experiencing hypoglycemia requiring oral treatment	During the day of the 24 hour intervention (7am-11pm)
Other	Gastrointestinal symptoms	Presence of gastrointestinal symptoms	24 hours
Primary	Time in target	Time spent in target range (between 4.0 mmol/L and 10 mmol/L)	24 hours
Primary	Time in hypoglycemia	Time spent in hypoglycemic range (below 4.0 mmol/L)	24 hours
Primary	Time in hyperglycemia	Time spent in hyperglycemic range (above 10.0 mmol/L)	24 hours