Recruiting

Observational Study

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06158503

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AID

Study Details

Brief summary:

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

Type 1 Diabetes

Study ID

NCT06158503

Start date

Feb 1, 2025

Status verified date

Feb, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

AID initiation

The participants will be selected on the basis that they are planning to start using one of the commercially available AID.

They will start treatment after the initial measurements (baseline), then repeat the measurements at 2 and 4 months post-AID.

Interventions

AID

Initiation of an automated insulin delivery system

Primary outcome measure

  • Bone remodeling improvement [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Elisabeth Nguyen

514-987-5617elisabeth.nguyen@ircm.qc.ca

Valérie Boudreau

514-987-5643valerie.boudreau@ircm.qc.ca

Locations

CHUM

Recruiting

Montréal, Quebec, Canada, H2X 3E4

Contacts

Rémi Rabasa-Lhoret

1-514-987-5762remi.rabasa-lhoret@ircm.qc.ca

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Canada

Contacts

Remi Rabasa-Lhoret

514-987-5500remi.rabasa-lhoret@ircm.qc.ca

Principal Investigator:

Remi Rabasa-Lhoret

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Feb 25, 2025

Last verified

Feb, 2025

Keywords

  • Type 1 Diabetes
  • Bone Health
  • Automated Insulin Delivery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-02-25.