💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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