NCT06158503Recruiting
Glycemic Control and Osteohealth in Adults Living With Type 1 Diabetes
GLYcemic COntrol and OSTEOhealth: Impact of Short-Term Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 28 Nov 2023
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Diseases
- Type 1 diabetes
- NCT number
- NCT06158503
What you commit to
- Study type: Observational
- Planned participants: 25
- From 1 Feb 2025 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
Lab values
- 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);
Other
- 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;
- Unable to consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHUM Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.