AID for Type 1 Diabetes

(GLYCO-OSTEO Trial)

Recruiting at 1 trial location

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

Trial Summary

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 data supports the effectiveness of the treatment AID for Type 1 Diabetes?

Research shows that Automated Insulin Delivery (AID) systems help people with type 1 diabetes manage their blood sugar levels better by automatically adjusting insulin based on glucose levels. These systems have been effective in improving blood sugar control and reducing the burden of managing diabetes in both clinical trials and real-world settings. ^{1 2 3 4 5}

Is tacrolimus safe for humans?

Tacrolimus, used in treating skin conditions like atopic dermatitis, has been shown to be effective but comes with a range of side effects. The FDA issued a warning about its use, and some patients have experienced severe skin reactions, suggesting caution is needed when using this medication. ^{6 7 8 9 10}

How is the AID treatment for type 1 diabetes different from other treatments?

The AID (Automated Insulin Delivery) treatment for type 1 diabetes is unique because it combines a continuous glucose monitor, an insulin pump, and an algorithm to automatically adjust insulin levels based on real-time glucose readings. This system reduces the burden of managing diabetes by optimizing insulin delivery, although users still need to manually administer insulin for meals. ^{1 2 5 11 12}

What is the purpose of this trial?

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.

Research Team

Rémi Rabasa-Lhoret, MD, PhD

Principal Investigator

IRCM

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Automated insulin delivery among adults with type 1 diabetes for up to 2 years: a real-world, multicentre study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Current Status and Emerging Options for Automated Insulin Delivery Systems. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Automated Insulin Delivery Systems: Today, Tomorrow and User Requirements. [2022]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Does insulin delivery technology change our relationship with foods? A scoping review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A safety review of the medications used to treat atopic dermatitis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Resolution of severe atopic dermatitis after tacrolimus withdrawal. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Current aspects of the therapy with topical calcineurin inhibitors]. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Comparative safety of systemic immunomodulatory medications in adults with atopic dermatitis. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Review of Automated Insulin Delivery Systems for Type 1 Diabetes and Associated Time in Range Outcomes. [2022]

12. England pubmed.ncbi.nlm.nih.gov

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