Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement
NCT ID: NCT03993366
Last Updated: 2021-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2019-03-01
2019-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
TREATMENT
NONE
Study Groups
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Simple Meal Announcement
Before every meal, the meal will be simply announced to the algorithm by a member of the study team. Meal bolus computation will be independent of the carbohydrate content of the meal.
Fiasp+Pramlintide Closed-Loop System
Closed-loop insulin delivery with Fiasp insulin and pramlintide
Full Carbohydrate counting
The carbohydrate content of the meal selected by the participant will be entered into the dosing algorithm by a member of the study team at the onset of the meal to compute the insulin prandial bolus.
Fiasp Closed-Loop System
Closed-loop insulin delivery with Fiasp insulin alone
Interventions
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Fiasp+Pramlintide Closed-Loop System
Closed-loop insulin delivery with Fiasp insulin and pramlintide
Fiasp Closed-Loop System
Closed-loop insulin delivery with Fiasp insulin alone
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
McGill University
OTHER
Responsible Party
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Locations
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McGill University Health Center
Montreal, Quebec, Canada
Countries
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Other Identifiers
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2019-4947
Identifier Type: -
Identifier Source: org_study_id
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