NCT06158503 Glycemic Control and Osteohealth in Adults Living With Type 1 Diabetes
| NCT ID | NCT06158503 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Type 1 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2025-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Bone damage is frequently observed in type 1 diabetes, and hyperglycemia is associated with an increased risk of fracture. This pilot study in 25 people living with type 1 diabetes aims to determine whether the introduction of an automated insulin delivery (AID) system improves bone markers through rapide optimization of glycemic control. Measurements will be taken before the start of AID, 2 months and 4 months afterwards.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years; * Diagnosis of T1D or latent autoimmune diabetes of adults (LADA) for at least one year; * Current HbA1c \>8.0% and high glycemic variability (CV \>36.0% using CGM); * Participant planning to start using one of the commercially available AID; * Anticipated use of the closed-loop mode; * Willing to share CGM data during the study period. Exclusion Criteria: * Woman who was pregnant, gave birth or breastfed less than 6 months before the beginning of the study or who plans to become pregnant during the study; * Conditions affecting bone turnover markers, such as chronic kidney disease (estimated GFR \<30 ml/min), liver disease, intestinal malabsorption including celiac disease, organ transplant, active cancer, rheumatoid arthritis, and endocrinopathies (active hyperthyroidism, uncontrolled hypothyroidism with abnormal TSH, parathyroid disease, hypogonadism, Cushing syndrome, adrenal insufficiency and acromegaly); * Anticipated therapeutic change and/or type of CGM sensor, insulin pump, or AID during the study period; * Anticipated need to use acetaminophen during the study period at a dose above 1g every 6 hours; * Current or anticipated use of hydroxyurea; * Intake in the past 12 months of drugs influencing bone turnover markers, such as oral or intra-articular glucocorticoids (≥ 7.5 mg daily Prednisone or equivalent during ≥ 3 months or ≥ four intra-articular glucocorticoid infiltrations in the past year), aromatase inhibitor therapy for breast cancer and anti-androgen therapy for prostate cancer, anticoagulants, SGLT-2 inhibitors, thiazolidinediones, and anti-osteoporosis drugs; * Unable to consent.
Contact & Investigator
Rémi Rabasa-Lhoret, MD, PhD
PRINCIPAL INVESTIGATOR
IRCM
Frequently Asked Questions
Who can join the NCT06158503 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06158503 currently recruiting?
Yes, NCT06158503 is actively recruiting participants. Contact the research team at elisabeth.nguyen@ircm.qc.ca for enrollment information.
Where is the NCT06158503 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT06158503 clinical trial?
NCT06158503 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Rémi Rabasa-Lhoret, MD, PhD at IRCM. The trial plans to enroll 25 participants.
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