Actively Recruiting
Glycemic Control and Osteohealth in Adults Living With Type 1 Diabetes
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-02-25
25
Participants Needed
2
Research Sites
125 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
L
Laval University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Glycemic Control and Osteohealth in Adults Living With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with type 1 diabetes or latent autoimmune diabetes of adults (LADA) for at least one year
- Current HbA1c greater than 8.0% and high glycemic variability (coefficient of variation above 36.0%) using continuous glucose monitoring
- Planning to start using a commercially available automated insulin delivery system
- Expect to use the closed-loop mode of the device
- Willing to share continuous glucose monitoring data during the study period
You will not qualify if you...
- Pregnant women, women who gave birth or breastfed less than 6 months before the study, or those planning pregnancy during the study
- Conditions affecting bone turnover markers such as chronic kidney disease (eGFR below 30 ml/min), liver disease, intestinal malabsorption including celiac disease, organ transplant, active cancer, rheumatoid arthritis, and certain endocrine disorders
- Anticipated changes in therapy or type of continuous glucose monitor, insulin pump, or automated insulin delivery during the study
- Anticipated need to use acetaminophen above 1g every 6 hours during the study
- Current or expected use of hydroxyurea
- Use in past 12 months of drugs affecting bone turnover markers, including certain glucocorticoids, aromatase inhibitors, anti-androgen therapy, anticoagulants, SGLT-2 inhibitors, thiazolidinediones, and anti-osteoporosis drugs
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
CHUM
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
2
Centre Hospitalier de l'Université de Montréal
Montreal, Canada
Actively Recruiting
Research Team
E
Elisabeth Nguyen
CONTACT
V
Valérie Boudreau
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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