COMBINATION_PRODUCT
Fiasp+Pramlintide Closed-Loop System
Closed-loop insulin delivery with Fiasp insulin and pramlintide
Status
Completed
Phase
Not applicable
Enrollment
8
Locations
1
Results
Not posted
Publications
0
Study 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
Interventions
COMBINATION_PRODUCT
Closed-loop insulin delivery with Fiasp insulin and pramlintide
DEVICE
Closed-loop insulin delivery with Fiasp insulin alone
Timeline
First posted
Jun 20, 2019
Study start
Mar 1, 2019
Primary completion
Aug 6, 2019
Study completion
Aug 6, 2019
Results posted
Not reported
Registry updated
Apr 1, 2021
Outcomes
Time in target
Time frame · 24 hours
Time spent in target range (between 4.0 mmol/L and 10 mmol/L)
Time in hypoglycemia
Time frame · 24 hours
Time spent in hypoglycemic range (below 4.0 mmol/L)
Time in hyperglycemia
Time frame · 24 hours
Time spent in hyperglycemic range (above 10.0 mmol/L)
Not reported in the indexed record.
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.
Study locations
Canada. Showing up to 24 locations stored in the fast local snapshot.
McGill University Health Center
Montreal, Quebec, Canada
Publications
No PMID-linked publications were present in this registry snapshot.
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