Type 1 diabetes Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus
Conditions
Interventions
This is an observational study. Participation in this research project will last approximately 12 weeks and will include 5 visits. Participants will wear an additional glucose sensor for 4 weeks and a
Sponsors
Montreal Clinical Research Institute (IRCM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females =18 years old 2. Clinical diagnosis of type 1 diabetes for at least 1 year (The diagnosis of type 1 diabetes is based on the investigator’s judgment; C-peptide level and antibody determinations are not needed) 3. Having been on AID therapy for at least 3 months 4. Willing to carry an additional CGM and a receiver for 30 days to collect blinded CGM data 5. Accepting that their pump setting parameters to be collected by the research team. This access will be limited to the study period
Exclusion criteria
Exclusion criteria: 1. Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R) 2. Clinically significant nephropathy (eGFR <15 ml/min/1.73m², planned or on dialysis), neuropathy (e.g., known uncontrolled gastroparesis) or retinopathy (e.g., proliferative retinopathy with ongoing active treatment such as laser photocoagulation or planned surgery) as judged by the investigator 3. Recent (<6 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery) 4. Anticipated therapeutic change (including change of insulin, CGM sensor or AID system type) between admission and end of the study 5. Anticipated need to use acetaminophen during the study period 6. Pregnancy (ongoing or current attempt to become pregnant) 7. Breastfeeding 8. Plan to go abroad in a foreign country during the study period 9. Severe hypoglycemic episode within two weeks of screening 10. Severe hyperglycemic episode requiring hospitalization in the last 3 months 11. Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®) 12. Agents affecting gastric emptying (Motilium®, Victoza®, Ozempic®, Trulicity®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, Prandase®, DPP-4 inhibitors) unless at a stable dose for 3 months and without anticipated change during the study. 13. Current use of SGLT-2 inhibitors unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed 14. Known or suspected allergy to the study products (e.g., Dexcom adhesive) 15. Other serious medical illness likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator 16. Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change) 17. Anticipated radiologic examination at the time of study assessment incompatible with CGM wear (e.g., MRI) 18. In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L (TIR%) measured using a worn glucose sensor over 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using a worn glucose sensor over 4 weeks: 1. Percentage of time of glucose levels. between 3.9 and 7.8 mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L; e. above 13.9 mmol/L 2. Mean glucose levels 3. Estimated HbA1c 4. Standard deviation (SD) and coefficient of variance (CV) of glucose levels 5. Episodes of hypoglycemia/hyperglycemia 6. Glucose area under the curve 7. Risk of hypoglycemia and hyperglycemia (low blood glucose index [LBGI] and high blood glucose index [HBGI]) measured using data from the glucose sensor over 4 weeks 8. Scores for QoL questionnaires (Hypoglycemia Fear Survey II, Diabetes Distress Scale, Diabetes Treatment Satisfaction Questionnaire, Pittsburgh Sleep Quality Index, and Audit of Diabetes Dependent Quality of Life) at baseline 9. SD and CV of insulin delivery measured using insulin records of 7 representative previous days of insulin therapy at week 4 10. Total insulin delivery measured using insulin records of 7 representative previous days of insulin therapy at week 4 11. Total number of hours and percentage of time of sensor availability | — |
Countries
Canada
Contacts
Public ContactAnne;Virginie Bonhoure;Messier
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Outcome results
None listed