AID for Type 1 Diabetes

(GLYCO-OSTEO Trial)

Recruiting at 2 trial locations

Overseen By Valérie Boudreau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must be taking: Automated insulin

Must not be taking: Glucocorticoids, Anticoagulants, SGLT-2 inhibitors, others

Disqualifiers: Pregnancy, Chronic kidney disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether an automated insulin delivery (AID) system can improve bone health in people with type 1 diabetes by better managing blood sugar levels. The study tracks changes in bone markers before and after starting AID. Individuals with type 1 diabetes for at least a year, high blood sugar levels, and plans to start using an AID system might be suitable candidates. As a Phase 2 trial, this research measures the AID system's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in diabetes care.

Will I have to stop taking my current medications?

The trial requires that you do not use certain medications that affect bone turnover markers, like glucocorticoids, aromatase inhibitors, anti-androgens, anticoagulants, SGLT-2 inhibitors, thiazolidinediones, and anti-osteoporosis drugs. If you are taking any of these, you may need to stop before joining the study.

What prior data suggests that this automated insulin delivery system is safe for people with type 1 diabetes?

Research has shown that automated insulin delivery (AID) systems are generally safe for people with type 1 diabetes. In past studies, these systems improved blood sugar control and reduced the risk of low blood sugar episodes. For example, one study found that people using AID experienced fewer low blood sugar incidents and better overall blood sugar levels. Another study found these systems particularly beneficial for those with diabetes for over 20 years. These findings suggest that AID systems are well-tolerated and offer safety benefits for managing type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AID (Automated Insulin Delivery) for Type 1 Diabetes because it offers a smarter way to control blood sugar levels. Unlike traditional methods like manual insulin injections or insulin pumps that require constant monitoring by the user, AID systems automatically adjust insulin delivery based on real-time glucose readings. This means less hassle and more precise control, potentially leading to better blood sugar management and fewer complications for people with Type 1 Diabetes. The ability to seamlessly integrate these systems into daily life and reduce the burden of diabetes management is what makes AID a promising development in diabetes care.

What evidence suggests that this AID system is effective for improving bone markers in type 1 diabetes?

Research has shown that automated insulin delivery (AID) systems effectively manage type 1 diabetes. Studies have found that AID systems control blood sugar more effectively than traditional insulin methods, reducing spikes and drops in blood sugar levels. Stable blood sugar is crucial as it lowers the risk of complications, such as bone damage. In daily life, individuals using AID systems have reported better overall health. These findings support the potential benefits of AID systems for people with type 1 diabetes. Participants in this trial will begin treatment with a commercially available AID system, with measurements taken at baseline, 2 months, and 4 months after initiation. ^{6 7 8 9 10}

Who Is on the Research Team?

Rémi Rabasa-Lhoret, MD, PhD

Principal Investigator

IRCM

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with Type 1 diabetes or LADA for over a year.

Participant planning to start using one of the commercially available AID

Current HbA1c >8.0% and high glycemic variability (CV >36.0% using CGM)

Exclusion Criteria

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

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

I haven't taken drugs affecting bone health in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial measurements and assessments before the installation of the automated insulin delivery system

1 day

1 visit (in-person)

Treatment

Participants start using the automated insulin delivery system and are monitored for changes in bone markers and glycemic control

4 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AID

Trial Overview 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.

How Is the Trial Designed?

Group I: AID initiation Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Laval University

Collaborator

Trials

439

Recruited

178,000+

Institut de Recherches Cliniques de Montreal

Collaborator

Trials

72

Recruited

10,300+

Published Research Related to This Trial

Automated insulin delivery (AID) systems, which combine rapid insulin analogs, insulin pumps, continuous glucose monitors, and control algorithms, have been shown to optimize metabolic control for individuals with type 1 diabetes.

The increasing availability and use of AID systems in the U.S. and Europe suggest they are becoming a key technology for achieving better glycemic control, as highlighted by the largest studies reviewed in this article.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status and Emerging Options for Automated Insulin Delivery Systems. Forlenza, GP., Lal, RA.[2023]

In a study involving 570 adult patients with moderate-to-severe atopic dermatitis, 0.1% tacrolimus ointment showed similar efficacy to 0.1% hydrocortisone butyrate, indicating it is a viable alternative treatment.

The 0.03% tacrolimus ointment was less effective than both the 0.1% tacrolimus and hydrocortisone butyrate, and while skin burning and itching were more common in the tacrolimus groups, no serious safety issues were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis. Reitamo, S., Rustin, M., Ruzicka, T., et al.[2022]

Atopic dermatitis (AD) is a prevalent condition that causes significant discomfort, and recent FDA-approved therapies offer new treatment options, but their long-term safety data is still limited.

The review highlights the need for effective AD medications that can be used long-term with minimal side effects, as current options are limited and the disease is chronic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A safety review of the medications used to treat atopic dermatitis. Shukla, S., Feldman, SR., Strowd, LC.[2022]

Topical calcineurin inhibitors, like Protopic and Elidel, are effective treatments for atopic eczema, but their use has been accompanied by a 'black box warning' from the FDA due to safety concerns.

The report reviews the evidence behind this warning and discusses the ongoing debate among dermatological societies regarding the safety and efficacy of these medications, highlighting the need for informed decision-making among patients and parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current aspects of the therapy with topical calcineurin inhibitors]. Enderlein, E., Meller, S., Rieker, J., et al.[2018]

Automated insulin delivery (AID) systems are associated with lower eating distress and improved quality of life for people with type 1 diabetes, suggesting they may ease the psychological burden of managing dietary intake.

AID users reported changes in eating behaviors, such as increased food intake and less parental dietary control, indicating that AID may alter how individuals with type 1 diabetes approach their nutrition, although more research is needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does insulin delivery technology change our relationship with foods? A scoping review. South, CA., Talbo, MK., Roy-Fleming, A., et al.[2023]

Automated insulin delivery (AID) systems, which combine continuous glucose monitors and insulin pumps, have shown improved glycaemic outcomes in managing type 1 diabetes mellitus (T1DM) through randomized controlled trials and real-world studies.

While AID systems enhance insulin management, they still require users to administer bolus doses for meals, highlighting the need for personalized care and the ongoing evolution of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Automated Insulin Delivery Systems for Type 1 Diabetes and Associated Time in Range Outcomes. Nallicheri, A., Mahoney, KM., Gutow, HA., et al.[2022]

Automated insulin delivery (AID) systems represent a significant advancement in managing type 1 diabetes (T1D), aiming to achieve glycemic targets while minimizing the risk of hypoglycemia and improving quality of life for users.

Despite their potential, current AID systems require further optimization and user education to enhance usability and reduce the burden of diabetes management, highlighting the importance of involving people with T1D in the design and assessment of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Insulin Delivery Systems: Today, Tomorrow and User Requirements. Giménez, M., Conget, I., Oliver, N.[2022]

In a study of up to 232,611 adults with severe atopic dermatitis, cyclosporine and methotrexate were found to have the lowest risk of serious bacterial and opportunistic infections, making them safer options for treatment.

Conversely, medications like prednisone, azathioprine, and mycophenolate were associated with increased risks of serious infections compared to methotrexate, highlighting the importance of careful medication selection in managing severe atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative safety of systemic immunomodulatory medications in adults with atopic dermatitis. Schneeweiss, MC., Perez-Chada, L., Merola, JF.[2021]

In a one-year study of 54 children and adolescents with type 1 diabetes, those using advanced hybrid closed-loop (AHCL) insulin delivery systems showed significantly better glucose control compared to those using hybrid closed-loop (HCL) systems, particularly in terms of time in range and mean sensor glucose levels.

Both AID systems were effective in maintaining glycemic targets, but the AHCL system allowed for longer periods of automatic mode activation and fewer manual adjustments, leading to improved usability and sustained glycemic outcomes without increasing the risk of hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Performance of First- Versus Second-Generation Automated Insulin Delivery Systems on a Pediatric Population With Type 1 Diabetes: A One-Year Observational Study. Bombaci, B., Passanisi, S., Valenzise, M., et al.[2023]

A patient with type 1 diabetes and a history of atopic dermatitis developed severe skin issues after starting tacrolimus as part of an immunosuppressive regimen following islet transplantation.

Discontinuing tacrolimus and switching to mycophenolate mofetil led to full remission of the dermatitis symptoms, indicating a potential adverse effect of tacrolimus on pre-existing atopic dermatitis without compromising islet graft function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resolution of severe atopic dermatitis after tacrolimus withdrawal. Ponte, GM., Baidal, DA., Romanelli, P., et al.[2019]

In many developing countries, type 1 diabetes can lead to a very short life expectancy, sometimes as little as 1 year, due to limited access to insulin, highlighting a significant health disparity compared to industrialized nations.

A proposal suggests that major insulin manufacturers could donate insulin to support type 1 diabetic patients in highly indebted poor countries, potentially preventing deaths caused by unaffordable insulin and improving health outcomes for these vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin for the world's poorest countries. Yudkin, JS.[2015]

In a study of 94 adults with type 1 diabetes, initiating first-generation automated insulin delivery (AID) led to a significant reduction in HbA1c levels by an average of 0.5 percentage points within 3 months, with improvements sustained for up to 2 years.

The most significant benefits were seen in individuals with higher pre-initiation HbA1c levels (above 8.5%), and the safety profile was favorable, with only a small percentage (13%) discontinuing AID due to challenges with continuous glucose monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated insulin delivery among adults with type 1 diabetes for up to 2 years: a real-world, multicentre study. Donaldson, LE., Fourlanos, S., Vogrin, S., et al.[2023]

Citations

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Efficacy of automated insulin delivery (AID) systems in type 1 ... The objective of this systematic review and meta-analysis is to assess the efficacy of AID systems in comparison with current intensified insulin therapy for ...

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Efficacy of automated insulin delivery systems in people ... This study includes a comprehensive comparison of the relative efficacy of various treatment options for type 1 diabetes through a systematic review and NMA.

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One-year evaluation of automated insulin delivery systems ... Introduction: This study evaluates the effectiveness of four commercially available automated insulin delivery (AID) systems in routine clinical ...

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Automated Insulin Delivery for Type 1 Diabetes: Present and ... Advancements in automated insulin delivery (AID) systems have transformed type 1 diabetes management, making AID the most effective technology

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Real-world glycaemic outcomes of automated insulin ... Abstract. Aim: To evaluate the real-world effectiveness of automated insulin delivery (AID) systems in patients with type 1 diabetes (T1D).

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Safety and Glycemic Outcomes With a Tubeless Automated ... Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase.

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Efficacy and Safety of Automated Insulin Delivery Systems in ... Patients on AID systems had more pronounced improvement of time below range when diabetes duration was more than 20 years (–1.80% vs. –0.86%, P=0.031) and ...

8. diabetesjournals.org diabetesjournals.org/care/article/46/12/2180/153654/Safety-and-Efficacy-of-Sustained-Automated-Insulin

Safety and Efficacy of Sustained Automated Insulin Delivery ... In adults with T1D at high risk for hypoglycemia, AID reduced the risk for hypoglycemia more than twofold, as quantified by TBR, while improving ...

9. e-dmj.org e-dmj.org/upload/pdf/dmj-2024-0130.pdf

Efficacy and Safety of Automated Insulin Delivery Systems ... We aimed to evaluate the efficacy and safety of AID systems in patients with type 1 diabetes mellitus (T1DM). Methods: We searched PubMed, Embase, Cochrane ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168822724008209

Real-world efficacy and safety of open-source automated ... This study aimed to describe efficacy and safety of android artificial pancreas (AAPS) in people with type 1 diabetes mellitus (T1DM) from mainland China.