Type 1 DiabetesGLYCO-OSTEONCT06158503
Glycemic Control and Osteohealth in Adults Living With Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- AID
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Feb 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
CHUM
Montreal, Quebec, H2X 3E4
Rémi Rabasa-Lhoret, 1-514-987-5762, remi.rabasa-lhoret@ircm.qc.ca
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal
Remi Rabasa-Lhoret, 514-987-5500 ext. 3227, remi.rabasa-lhoret@ircm.qc.ca
Remi Rabasa-Lhoret
About this study
Official title: 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.
Read the 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:
- Visit 1: before installation of the automated insulin delivery system,
- Visit 2: follow-up at 2 months after installation of the automated insulin delivery system,
- 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.
- Conditions
- Type 1 Diabetes
- Being tested
- AID
- Keywords
- Type 1 Diabetes, Bone Health, Automated Insulin Delivery
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIDDevice
Initiation of an automated insulin delivery system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months
Secondary outcomes (8)
Carboxy-terminal collagen crosslinks change
Magnitude of the change and the variance for CTX
Measured: 2 months
Carboxy-terminal collagen crosslinks change
Magnitude of the change and the variance for CTX
Measured: 4 months
N-terminal propeptide (P1NP) change
Magnitude of the change and the variance for P1NP
Measured: 2 months
N-terminal propeptide (P1NP) change
Magnitude of the change and the variance for P1NP
Measured: 4 months
Osteocalin change
Magnitude of the change and the variance for Osteocalin
Measured: 2 months
Osteocalin change
Magnitude of the change and the variance for Osteocalin
Measured: 4 months
HbA1c change
Mean change of glycated hemoglobin (HbA1c)
Measured: 2 months
HbA1c change
Mean change of glycated hemoglobin (HbA1c)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University, Institut de Recherches Cliniques de Montreal
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Centre hospitalier de l'Université de Montréal (CHUM)
- Investigators
- Rémi Rabasa-Lhoret, MD, PhD, Principal investigator, IRCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158503
- Sponsor's protocol ID
- MP-02-2024-11708
- Acronym
- GLYCO-OSTEO
- Status last verified
- Feb 2025
- First submitted
- 28 Nov 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLYcemic COntrol and OSTEOhealth: Impact of Short-Term Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06158503
- Acronym / sponsor ID
- GLYCO-OSTEO / MP-02-2024-11708
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Bone Health, Automated Insulin Delivery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Laval University, Institut de Recherches Cliniques de Montreal
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Visit 1: before installation of the automated insulin delivery system,
- Visit 2: follow-up at 2 months after installation of the automated insulin delivery system,
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AID initiation | – | Device: AIDThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIDInitiation of an automated insulin delivery system | Device | AID initiation |
Primary outcome
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).
8 secondary outcomes
Carboxy-terminal collagen crosslinks change
Time frame: 2 months
Carboxy-terminal collagen crosslinks change
Time frame: 4 months
N-terminal propeptide (P1NP) change
Time frame: 2 months
N-terminal propeptide (P1NP) change
Time frame: 4 months
Osteocalin change
Time frame: 2 months
Osteocalin change
Time frame: 4 months
HbA1c change
Time frame: 2 months
HbA1c change
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rémi Rabasa-Lhoret, MD, PhD principal investigator
IRCM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Nguyen (514-987-5617, elisabeth.nguyen@ircm.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone remodeling improvement (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.