Status:
COMPLETED
Assessment of the Efficacy of the Artificial Pancreas Combined With a Qualitative Meal Size Estimation to Control Postprandial Glucose Levels
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Postprandial glycemic excursions are major determinants of overall glycemic control in type 1 diabetes. Carbohydrate content of ingested meals is the main determinant of post-meal glucose excursion. A...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- The subject will have been on insulin pump therapy for at least 3 months.
- Currently using, or willing to switch to Lispro U100 or Aspart for the duration of the study.
- HbA1c \< 10%.
- Exclusion criteria
- Clinically significant nephropathy, neuropathy (e.g. known or suspected gastroparesis) or retinopathy (e.g. proliferative retinopathy) as judged by the investigator
- Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
- Anticipated need to use acetaminophen during interventions with the closed-loop system
- Pregnancy (ongoing or current attempt to become pregnant)
- Breastfeeding
- No nearby third party for assistance if needed (e.g. severe hypoglycemia glucagon treatment)
- Plans to go abroad or travel at more than 3 hours distance from Montreal during the trial period
- Severe hypoglycemic episode within two weeks of screening or during the run-in period
- Severe hyperglycemic episode requiring hospitalization in the last 3 months
- Current use of glucocorticoid medication (except low stable dose and inhaled steroids)
- Agents affecting gastric emptying (Motilium®, Victoza®, Ozempic®, Trulicity®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, Prandase®, DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
- Current use of SGLT-2 inhibitors unless at a stable dose for at least 3 months and appropriate ketone testing performed.
- Known or suspected allergy to the trial products
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator
- Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)
- In the opinion of the investigator, a participant who in unable or unwilling to observed the contraindications of the study devices
Exclusion
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04031599
Start Date
July 10 2020
End Date
December 14 2021
Last Update
January 28 2022
Active Locations (2)
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1
Montreal Clinical Research Institute
Montreal, Quebec, Canada, H2W 1R7
2
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1