Type 1 Diabetes Mellitus
Conditions
Keywords
type 1 diabetes, artificial pancreas, pramlintide, closed-loop
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
Interventions
COMBINATION_PRODUCTFiasp+Pramlintide Closed-Loop System
Closed-loop insulin delivery with Fiasp insulin and pramlintide
DEVICEFiasp Closed-Loop System
Closed-loop insulin delivery with Fiasp insulin alone
Sponsors
Juvenile Diabetes Research Foundation
McGill University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in target | 24 hours | Time spent in target range (between 4.0 mmol/L and 10 mmol/L) |
| Time in hypoglycemia | 24 hours | Time spent in hypoglycemic range (below 4.0 mmol/L) |
| Time in hyperglycemia | 24 hours | Time spent in hyperglycemic range (above 10.0 mmol/L) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia treatment | 24 hrs | Number of participants experiencing hypoglycemia requiring oral treatment |
| Gastrointestinal symptoms | 24 hours | Presence of gastrointestinal symptoms |
Countries
Canada
Outcome results
None listed