An observational study in Type 1 Diabetes, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 2 sites in Canada. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational
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.
Background: Bone damage is a frequently overlooked complication of type 1 diabetes (T1D), but significantly increases the risk of fractures as early as childhood. Fractures in individuals with T1D increase the risk of delayed healing, postoperative complications, loss of autonomy, reduced quality of life and even mortality. The pathophysiology of bone alterations in T1D probably differs from that of primary osteoporosis. Studies show lower bone mineral density in T1D, but this is not sufficient to fully explain the risk of fractures. T1D is also characterized by low bone remodeling and altered bone microarchitecture. Although chronic hyperglycemia is a risk factor for fracture in T1DM, the effect of improved glycemic control on bone markers remains unclear. The main hypothesis is that rapid optimization of the glycemic profile (hyperglycemia and variability) may improve bone remodeling in people living with T1DM who have suboptimal glycemic control.
Aim: The primary objective of this pilot study is to quantify the proportion of participants significantly increasing at least one of the serum markers of bone remodeling post-installation of an automated insulin delivery system.
Secondary objectives are to quantify: 1) the magnitude of change in each of the serum markers of bone remodeling pre-intervention and at 2 and 4 months post-intervention; 2) the efficacy of the automated insulin delivery system in terms of glycemic control and variability (mean change in HbA1c and glycemic parameters derived from the continuous glucose monitoring system).
Methods: method: This is a prospective pilot study involving 25 adults aged 18 and over living with T1DM or latent autoimmune diabetes of adults (LADA) who are interested in starting an automated insulin delivery system (artificial pancreas).
This study will involve 3 visits:
During visits 1 and 3, participants will take a blood sample, perform a brief physical examination and complete questionnaires.
During visit 1, participants will also undertake a urine sample, and the research team will conduct a brief interview to obtain information on their diabetes diagnosis, associated complications, and medication use.
During Visit 2: blood sample only.
The project will not interfere with the participant's diabetes management. They will be asked to share a copy of their 14-day continuous glucose monitoring profile during the visit periods.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's planned enrollment of 25 is below the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
People living with type 1 diabetes who do not use an automated insulin delivery system but wish to do so. The study takes place around the initiation of AID.
Exclusion Criteria:
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.
Device: AID
Initiation of an automated insulin delivery system
Bone remodeling improvement
The proportion of participants increasing at least one of the serum bone turnover markers above the least significant change (\>43% for CTX, \>25.49% for procollagen type 1 N-terminal propeptide (P1NP) and \>25.65% for osteocalin).
Time frame: 4 months
Carboxy-terminal collagen crosslinks change
Magnitude of the change and the variance for CTX
Time frame: 2 months
Carboxy-terminal collagen crosslinks change
Magnitude of the change and the variance for CTX
Time frame: 4 months
N-terminal propeptide (P1NP) change
Magnitude of the change and the variance for P1NP
Time frame: 2 months
N-terminal propeptide (P1NP) change
Magnitude of the change and the variance for P1NP
Time frame: 4 months
Osteocalin change
Magnitude of the change and the variance for Osteocalin
Time frame: 2 months
Osteocalin change
Magnitude of the change and the variance for Osteocalin
Time frame: 4 months
HbA1c change
Mean change of glycated hemoglobin (HbA1c)
Time frame: 2 months
HbA1c change
Mean change of glycated hemoglobin (HbA1c)
Time frame: 4 months
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Centre hospitalier de l'Université de Montréal (CHUM)