Status:
RECRUITING
Glycemic Control and Osteohealth in Adults Living With Type 1 Diabetes
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Laval University
Institut de Recherches Cliniques de Montreal
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-100 years
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 w...
Detailed Description
Background: Bone damage is a frequently overlooked complication of type 1 diabetes (T1D), but significantly increases the risk of fractures as early as childhood. Fractures in individuals with T1D inc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06158503
Start Date
February 1 2025
End Date
June 30 2027
Last Update
February 25 2025
Active Locations (2)
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1
CHUM
Montreal, Quebec, Canada, H2X 3E4
2
Centre Hospitalier de l'Université de Montréal
Montreal, Canada