Improving bone health in adults with type 1 diabetes using automated insulin delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the impact of an automated insulin delivery (AID) system on bone health in adults living with type 1 diabetes. It aims to determine whether optimizing glycemic control through AID can improve serum markers of bone remodeling. The study will involve 25 participants who will be monitored before starting AID and at two and four months after its initiation. The primary goal is to quantify the proportion of participants who show significant increases in bone remodeling markers post-intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chum
  Montreal, Quebec, Canada Recruiting
• Centre Hospitalier de l'Université de Montréal
  Montreal, Canada Recruiting

Study contacts

• Principal investigator: Rémi Rabasa-Lhoret, MD, PhD — Ircm
• Study coordinator: Elisabeth Nguyen
• Email: elisabeth.nguyen@ircm.qc.ca
• Phone: 514-987-5617

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.