Automated Insulin Delivery for Type 1 Diabetes

(AIMING Trial)

Overseen By Principal Investigator

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: AID systems

Must not be taking: Glucose metabolism drugs

Disqualifiers: Planned cesarean, Fetal demise, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: From admission to labor/delivery unit to birth of infant

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that interfere with glucose metabolism.

What data supports the effectiveness of the treatment Automated insulin delivery (AID) system for Type 1 Diabetes?

Research shows that automated insulin delivery (AID) systems improve blood sugar control in people with type 1 diabetes, and these improvements can last for up to 2 years. AID systems are considered the most effective technology for managing blood sugar levels in type 1 diabetes. ^{1 2 3 4 5}

Is automated insulin delivery safe for humans?

Automated insulin delivery (AID) systems have been shown to be safe for people with type 1 diabetes, as they help manage blood sugar levels effectively. Clinical studies have confirmed their safety and effectiveness, and they have been approved for use in both children and adults. ^{1 3 5 6 7}

How is the Automated Insulin Delivery system different from other treatments for type 1 diabetes?

The Automated Insulin Delivery (AID) system is unique because it combines insulin pumps, continuous glucose monitors, and control algorithms to automatically adjust insulin levels based on real-time glucose readings, optimizing blood sugar control more effectively than traditional methods. ^{1 2 4 5 6}

What is the purpose of this trial?

The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are * What are the neonatal glycemic outcomes with use of AID systems during labor/delivery? * Do patients report higher birth satisfaction with use of AID systems during labor/delivery? * Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor/delivery? Researchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.

Research Team

Ivonne Verduzco, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for pregnant individuals with type 1 diabetes or gestational diabetes. They are looking to see if an automated insulin delivery system can better manage blood sugar during labor compared to the standard IV insulin treatment.

Inclusion Criteria

Currently pregnant at 34 weeks or more

Current use of commercially available AID system for at least 6 months

Singleton pregnancy

Exclusion Criteria

Intrauterine fetal demise

Physical or psychological disease likely to interfere with the conduct of the study and/or the ability to participate in own healthcare

Planned cesarean delivery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either automated insulin delivery (AID) systems or intravenous (IV) insulin for glucose management during labor/delivery

From admission to labor/delivery unit to birth of infant

Follow-up

Participants are monitored for neonatal glucose values and birth satisfaction

2 weeks

Treatment Details

Interventions

• Automated insulin delivery (AID) system

Trial Overview The study compares two methods of controlling blood sugar during labor: a traditional intravenous (IV) insulin approach and an automated insulin delivery (AID) system. Participants will be randomly assigned to one of these treatments.

Participant Groups

Group I: Automated insulin delivery (AID) system Experimental Treatment 1 Intervention

Group II: Intravenous (IV) insulin Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

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 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 have been shown to be safe and effective in improving blood sugar control for individuals with type 1 diabetes, supported by large randomized controlled studies and recent commercial approvals.

Despite their success, AID systems still face challenges in being optimized for specific groups such as young children, athletes, pregnant women, seniors, and those with hypoglycemia unawareness, indicating a need for further advancements in technology tailored to these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Automated Insulin Delivery Systems for Individuals with Type 1 Diabetes: Tailored Solutions for Subpopulations. Aiello, EM., Deshpande, S., Ozaslan, B., et al.[2022]

References

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

Safety and Efficacy of Sustained Automated Insulin Delivery Compared With Sensor and Pump Therapy in Adults With Type 1 Diabetes at High Risk for Hypoglycemia: A Randomized Controlled Trial. [2023]

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

A Systematic Review of Commercial Hybrid Closed-Loop Automated Insulin Delivery Systems. [2023]

3. 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]

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

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

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

Open-Source Automated Insulin Delivery in Type 1 Diabetes. [2023]

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

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

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

Review of Automated Insulin Delivery Systems for Individuals with Type 1 Diabetes: Tailored Solutions for Subpopulations. [2022]