Glycemic Control and Osteohealth in Adults Living With Type 1 Diabetes

NCT06158503 | Recruiting

• 1 other identifier: MP-02-2024-11708
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

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

Keywords

Type 1 Diabetes; Bone Health; Automated Insulin Delivery

Outcome Measures

Primary Outcomes (1)

• 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).

  4 months

Secondary Outcomes (8)

• Carboxy-terminal collagen crosslinks change

  2 months

• Carboxy-terminal collagen crosslinks change

  4 months

• N-terminal propeptide (P1NP) change

  2 months

• N-terminal propeptide (P1NP) change

  4 months

• Osteocalin change

  2 months

Study Arms (1)

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

Interventions

AID DEVICE

Initiation of an automated insulin delivery system

AID initiation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Laval University: collaborator
• Institut de Recherches Cliniques de Montreal: collaborator

Study Sites (2)

CHUM

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples before and after initiation of the AID system.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Rémi Rabasa-Lhoret, MD, PhD

  IRCM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Nguyen

CONTACT

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

Valérie Boudreau

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

CA (2)