Type 1 Diabetes (T1D)AIMINGNCT06883344
Automated Insulin for Management of Intrapartum Glycemia
A study testing Automated insulin delivery (AID) system and Intravenous (IV) insulin in people with Type 1 Diabetes (T1D) and Pregnancy, run by University of California, San Francisco at 3 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Type 1 Diabetes (T1D), Pregnancy, Pre-Gestational Diabetes
- What is being tested?
- Automated insulin delivery (AID) system and Intravenous (IV) insulin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Currently pregnant at ≥ 34 weeks
- Known diagnosis of type 1 diabetes ≥ 1 year
- Use of commercially available AID system since at least 28 weeks gestation
- Singleton pregnancy
- English- or Spanish-speaking
Who cannot join
- Multifetal gestation
- Planned cesarean delivery
- Use of medications known to interfere with glucose metabolism
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Dana Levine-Lopez, 310-267-4331, ictu@mednet.ucla.edu
Christina Han
- Recruiting
University of California, San Diego
San Diego, California, 92121
CORI Study Team, 858-249-5985, CORIstudyteam@health.ucsd.edu
Gladys (Sandy) Ramos
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Nasim Sobhani, 415-307-9319, dappresearch@ucsf.edu
Ivonne Verduzco
About this study
Official title: Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Multicenter Randomized Controlled 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.
- Conditions
- Type 1 Diabetes (T1D), Pregnancy, Pre-Gestational Diabetes
- Being tested
- Automated insulin delivery (AID) system, Intravenous (IV) insulin
- Keywords
- Pregnancy, Intrapartum glycemic management, Neonatal hypoglycemia, Perinatal care, Diabetes in pregnancy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated insulin delivery (AID) systemDevice
An AID system incorporates data from a continuous glucose monitor (CGM) to automatically adjust the amount of insulin delivered by an insulin pump via an algorithm that incorporates multiple factors, including predicted glucose level in the next 30-60 minutes, target glucose level, and recent insulin delivery.
Intravenous (IV) insulinOther
Variable rate IV insulin infusions are used in most labor/delivery units as the standard of care for glycemic management for pregnant people with T1D. A continuous rate of IV insulin is infused, with manual rate adjustments made based on current glucose level and hospital-specific protocols.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous (IV) insulin | Active comparator | Not described Receives: Other: Intravenous (IV) insulin |
| Automated insulin delivery (AID) system | Experimental | Not described Receives: Device: Automated insulin delivery (AID) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
First neonatal glucose value
A primary clinical goal of intrapartum glycemic management is to minimize the likelihood of low neonatal glucose values (hypoglycemia).
Measured: Within 2 hours of birth
Secondary outcomes (2)
Birth Satisfaction Scale Revised (BSS-R) score
The BSS-R is a 10-item, multi-dimensional, psychometric instrument that has been validated as a measure of birth satisfaction. This endpoint was selected to adequately assess patient perception of quality of care received and labor-related stress experienced.
Measured: Within 2 weeks of delivery
CGM-derived glycemic parameters
Glycemic parameters like time in range (TIR), time below range (TBR), and time above range (TAR) will be examined as markers of intrapartum glycemia
Measured: From admission to labor/delivery unit to birth of infant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start5 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasim Sobhani, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883344
- Sponsor's protocol ID
- 25-43619
- Acronym
- AIMING
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06883344
- Acronym / sponsor ID
- AIMING / 25-43619
- Conditions
- Type 1 Diabetes (T1D), Pregnancy, Pre-Gestational Diabetes
- Keywords
- Pregnancy, Intrapartum glycemic management, Neonatal hypoglycemia, Perinatal care, Diabetes in pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous (IV) insulin | Active comparator | Other: Intravenous (IV) insulin |
| Automated insulin delivery (AID) system | Experimental | Device: Automated insulin delivery (AID) system |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Currently pregnant at ≥ 34 weeks
- Known diagnosis of type 1 diabetes ≥ 1 year
- Use of commercially available AID system since at least 28 weeks gestation
- Singleton pregnancy
- English- or Spanish-speaking
Key exclusion criteria (5 listed)
- Multifetal gestation
- Planned cesarean delivery
- Use of medications known to interfere with glucose metabolism
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated insulin delivery (AID) systemAn AID system incorporates data from a continuous glucose monitor (CGM) to automatically adjust the amount of insulin delivered by an insulin pump via an algorithm that incorporates multiple factors, including predicted glucose level in the next 30-60 minutes, target glucose level, and recent insulin delivery. | Device | Automated insulin delivery (AID) system |
| Intravenous (IV) insulinVariable rate IV insulin infusions are used in most labor/delivery units as the standard of care for glycemic management for pregnant people with T1D. A continuous rate of IV insulin is infused, with manual rate adjustments made based on current glucose level and hospital-specific protocols. | Other | Intravenous (IV) insulin |
Primary outcome
First neonatal glucose value
Time frame: Within 2 hours of birth
A primary clinical goal of intrapartum glycemic management is to minimize the likelihood of low neonatal glucose values (hypoglycemia).
2 secondary outcomes
Birth Satisfaction Scale Revised (BSS-R) score
Time frame: Within 2 weeks of delivery
CGM-derived glycemic parameters
Time frame: From admission to labor/delivery unit to birth of infant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nasim Sobhani, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated insulin delivery (AID) system and Intravenous (IV) insulin in people with Type 1 Diabetes (T1D) and Pregnancy, run by University of California, San Francisco at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DAPP Principal Investigator ((415) 307-9319, dappresearch@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First neonatal glucose value (time frame: Within 2 hours of birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.