Glycemic Control and Osteohealth in Adults Living with Type 1 Diabetes (GLYCO-OSTEO)

February 24, 2025 updated by: Rémi Rabasa-Lhoret, Centre hospitalier de l'Université de Montréal (CHUM)

GLYcemic COntrol and OSTEOhealth: Impact of Short-Term Glycemic Control on Skeletal Outcomes in Adults with Type 1 Diabetes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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:

  1. Visit 1: before installation of the automated insulin delivery system,
  2. Visit 2: follow-up at 2 months after installation of the automated insulin delivery system,
  3. Visit 3: follow-up at 4 months after installation of the automated insulin delivery system.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
      • Montreal, Canada
        • Recruiting
        • Centre Hospitalier de L'Universite de Montreal
        • Contact:
        • Contact:
          • Remi Rabasa-Lhoret
    • Quebec
      • Montréal, Quebec, Canada, H2X 3E4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: AID
Initiation of an automated insulin delivery system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bone remodeling improvement
Time Frame: 4 months
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).
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Carboxy-terminal collagen crosslinks change
Time Frame: 2 months
Magnitude of the change and the variance for CTX
2 months
Carboxy-terminal collagen crosslinks change
Time Frame: 4 months
Magnitude of the change and the variance for CTX
4 months
N-terminal propeptide (P1NP) change
Time Frame: 2 months
Magnitude of the change and the variance for P1NP
2 months
N-terminal propeptide (P1NP) change
Time Frame: 4 months
Magnitude of the change and the variance for P1NP
4 months
Osteocalin change
Time Frame: 2 months
Magnitude of the change and the variance for Osteocalin
2 months
Osteocalin change
Time Frame: 4 months
Magnitude of the change and the variance for Osteocalin
4 months
HbA1c change
Time Frame: 2 months
Mean change of glycated hemoglobin (HbA1c)
2 months
HbA1c change
Time Frame: 4 months
Mean change of glycated hemoglobin (HbA1c)
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut de Recherches Cliniques de Montreal
Laval University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD, IRCM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MP-02-2024-11708

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes

Clinical Trials on AID

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings