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AID for Type 1 Diabetes (GLYCO-OSTEO Trial)

N/A

Waitlist Available

Led By Rémi Rabasa-Lhoret, MD, PhD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Be older than 18 years old

Must not have

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

Current or anticipated use of hydroxyurea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if an automated insulin system can reduce bone damage in people with type 1 diabetes by helping to regulate blood sugar levels.

Who is the study for?

This trial is for adults over 18 with Type 1 Diabetes or LADA, who have had it for at least a year. They should have high blood sugar levels (HbA1c >8.0%) and variability (CV >36.0%). Participants must be planning to use an AID system and willing to share their data. Pregnant women, those with conditions affecting bones, or taking certain medications are excluded.

What is being tested?

The study tests if using an automated insulin delivery (AID) system can improve bone health in people with type 1 diabetes by quickly optimizing blood sugar control. Bone markers will be measured before starting AID, then after 2 and 4 months of use.

What are the potential side effects?

While the trial focuses on glycemic control rather than side effects, potential risks may include low blood sugar episodes due to insulin adjustments when starting the AID system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been pregnant, given birth, or breastfed in the last 6 months or plan to become pregnant.

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I am currently taking or plan to take hydroxyurea.

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I expect to need more than 1g of acetaminophen every 6 hours.

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I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bone remodeling improvement

Secondary study objectives

Carboxy-terminal collagen crosslinks change

HbA1c change

N-terminal propeptide (P1NP) change

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AID initiationExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met