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

GLYcemic COntrol and OSTEOhealth: Impact of Short-Term Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes

This study is testing if using an automated insulin delivery system can help improve bone health in adults with type 1 diabetes.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Academic / other)
• Drugs / interventions: Prednisone
• Locations: 2 sites (Montreal, Quebec and 1 other locations)
• Trial ID: NCT06158503 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with type 1 diabetes or latent autoimmune diabetes of adults, currently experiencing high glycemic variability.

Not a fit: Patients with conditions affecting bone turnover or those who are pregnant or planning to become pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved bone health and reduced fracture risk for patients with type 1 diabetes.

How similar studies have performed: While studies have shown the relationship between glycemic control and bone health, this specific approach using automated insulin delivery is novel and has not been extensively tested.

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.

Where this trial is running

Montreal, Quebec and 1 other locations

• 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

Conditions Type 1 Diabetes; Bone Health; Automated Insulin Delivery