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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an automated insulin delivery (AID) system can manage blood sugar levels more effectively than the usual IV insulin during labor for pregnant individuals with type 1 diabetes. Researchers aim to determine if AID systems lead to better newborn health, improved blood sugar control, and higher birth satisfaction. Participants will be randomly assigned to use either the AID system or continue with IV insulin. The trial seeks pregnant individuals who have had type 1 diabetes for at least a year, currently use an AID system, and are in their 34th week or later of a single pregnancy. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance diabetes management during labor.

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 prior data suggests that automated insulin delivery systems are safe for glucose management during labor and delivery?

Studies have shown that an automated insulin delivery (AID) system is safe for many people with type 1 diabetes. Participants in previous studies experienced better blood sugar control and fewer instances of low blood sugar. However, a small risk of developing diabetic ketoacidosis exists, a serious condition where the body produces too many acids called ketones. This risk may be higher for some individuals. Overall, the AID system has been well-tolerated, but discussing specific situations with a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the automated insulin delivery (AID) system for Type 1 Diabetes because it offers a cutting-edge way to manage blood sugar levels. Unlike traditional methods like multiple daily injections or continuous subcutaneous insulin infusion, the AID system automatically adjusts insulin delivery in real-time based on glucose readings. This automation reduces the burden of constant monitoring and manual adjustments, potentially leading to better glucose control and improved quality of life for patients.

What evidence suggests that automated insulin delivery systems are effective for glucose management during labor and delivery?

Research has shown that automated insulin delivery (AID) systems, one of the treatments studied in this trial, effectively manage type 1 diabetes. Studies have found that AID systems maintain blood sugar levels within the target range more often than traditional methods. For example, one study found that after starting AID therapy, individuals with type 1 diabetes improved their average time-in-range (TIR) from 53.4% to 70% or more. This improvement indicates better overall blood sugar control, which is crucial for health. AID systems are considered the best way to manage type 1 diabetes, transforming how people live with the condition. These systems are particularly helpful for managing blood sugar during challenging times, such as childbirth. ^{2 3 5 6 7}

Who Is on the Research Team?

Ivonne Verduzco, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12017971/

Efficacy of automated insulin delivery systems in people with ... The results showed that AID systems were beneficial to varying degrees with respect to the percentage of time in the range of 70–180 mg/dl and ...

2. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2025.1596188/full

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 ...

3. diabetesjournals.org diabetesjournals.org/spectrum/article/38/3/217/163136/Automated-Insulin-Delivery-for-Type-1-Diabetes

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 ...

4. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2838298

Automated Insulin Delivery Systems and Glucose ... Meaning Results suggest that AIDs are an effective way to improve measures of glucose management in children and adolescents with type 1 ...

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16485

Real‐world evaluation of automated insulin delivery therapy in ... The study consisted of 158 people living with T1DM who were initiated on AID. Following AID initiation, mean TIR improved from 53.4% (SD 21.1%) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9346983/

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.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025001221

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.