Type 1 DiabetesNCT07808385
Single Arm Intervention Trial of DEKA TWIIST TM Insulin Pump Utilizing Tidepool Loop Algorithm in Pregnant People With Pre-existing Type 1 Diabetes
A study testing Automated Insulin Delivery (AID) in people with Type 1 Diabetes and Pregnancy, run by Mayo Clinic at 4 sites in United States.
Trial summary
Suboptimal glycemic control during pregnancy contributes to adverse maternal and fetal health outcomes and previous automated insulin delivery (AID) studies have demonstrated improvement in glucose control across all ages and sexes irrespective of past treatment modality or diabetes duration with no increase in… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type 1 Diabetes, Pregnancy
- What is being tested?
- Automated Insulin Delivery (AID)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2026to 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy is confirmed by ultrasound.
- Pregnant woman between pregnancy confirmation to 96/7 weeks gestation.
- Clinical diagnosis of T1D for 1 year or longer.
- Using insulin pump (AID/SAP) or multiple daily insulin injections at screening visit.
- Willing to use U100 aspart (Novolog) or lispro (Humalog) insulin during the study.
- Willing to announce all carbohydrate intake unless for the treatment or prevention of hypoglycemia.
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- No significant maternal and/or fetal complications at the time of enrollment visit.
- Willing to abide by study protocol.
- Willing to learn and use study-provided devices and perform necessary actions for interacting with devices when needed.
- Able and willing to receive routine and specialty obstetric care during the study.
- Able to speak and understand English and provide informed consent.
- Able to have at least one care partner available during the study. A care partner is defined as an adult person (≥18 yrs.) who will either be staying in the same location as the participant or within a 40-mile radius and willing to be trained on study devices and using the TWIIST smartphone App (follower app), will to provide treatment of hypo- and hyperglycemia, and able to take the participant to the hospital or call 911 (emergency services) in case of an emergency.
Who cannot join
- Individuals with T2D, gestational diabetes, or other types of diabetes (e.g., CFRD, MODY, etc.).
- Use of basal insulin alone.
- Use of short-acting insulin alone, unless use is through an insulin pump.
- Severe allergy to medical grade adhesives within the last 3 months that would inhibit participant ability to wear the study devices.
- Significant maternal and/or fetal complications, such as pre-existing heart disease (untreated or unstable cardiac diseases), pre-existing severe kidney (eGFR < 45) disease and any other condition that limits participant safety as per investigator discretion.
- Unwilling to wear the study insulin pump for the duration of the study or unwilling to switch from current insulin therapy to investigational device for duration of the study.
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- Presence of significant skin diseases/changes at sensor or infusion wear sites (for example: extensive scarring, extensive eczema, dermatitis herpetiformis, extensive burn or extensive psoriasis).
- Multifetal pregnancy.
- Inadequate access to a phone and/or computer (for downloading devices and web-based communications).
- Unable to attend required on-site study visits due to a planned move to a non-commutable distance to the study site.
- People with advanced diabetes complications such as advanced nephropathy (creatinine >1.5 mg/dl, eGFR <45 or currently on dialysis), severe autonomic neuropathy, uncontrolled gastroparesis, advanced retinopathy requiring active treatments or as per investigator judgment.
- Any bleeding disorder or hemophilia.
- Abnormal TSH 6 weeks after two consecutive titrations of thyroid medications
- Adrenal insufficiency.
- History of severe hypoglycemic event or DKA requiring hospitalization in the past 3 months or greater than 1 episode of DKA within the last year.
- Currently being treated for malignancies.
- Organ transplant recipient.
- On ultra rapid acting insulin, inhaled insulin or U200 insulin unless willing to switch to an insulin with existing data on pump compatibility.
- Daily insulin dose ≥ 1.5 units/kg/day at enrollment.
- Current use of any non-insulin glucose lowering agents except metformin, unless willing to discontinue use of said agents to participate in the study.
- Chronic oral steroid use, current oral steroid use, or high dose steroid use (oral or injectable) in the last 2 months.
- Body mass index > 40 kg/m2 at enrollment.
- Known or suspected allergy to insulin.
- Severe visual or hearing impairment preventing successful use of study system.
- Participant has any condition (physical or psychological disease) that in the opinion of the site investigator would interfere with the normal conduct and interpretation of the study results or put participant at risk during the study.
- Currently participating in another pharmaceutical or device related interventional trial at the time of enrollment or any time during the study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
Sarit Polsky, MC, 8139758690, ppwt1d@jaeb.org
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Carol Levy, MD, 8139758690, ppwt1d@jaeb.org
Mayo Clinic
Rochester, Minnesota, 55905
Stanford University
Stanford, California, 94305
Rayhan Lal, MD, 8139758690, ppwt1d@jaeb.org
About this study
Suboptimal glycemic control during pregnancy contributes to adverse maternal and fetal health outcomes and previous automated insulin delivery (AID) studies have demonstrated improvement in glucose control across all ages and sexes irrespective of past treatment modality or diabetes duration with no increase in hypoglycemia. However, very few studies evaluating AID system use in pregnancy have been performed in the US and no AID systems are currently approved for use during pregnancy. The objective of this trial is to evaluate the safety and efficacy of THE TWIIST™ system that enables the selection of pregnancy-specific glucose targets. This phase 3 pivotal trial will assess the system's performance in pregnant people with pre-existing type 1 diabetes in the US, starting as early as pregnancy confirmation, continuing throughout the pregnancy including delivery and up to 6 weeks post-partum.
- Conditions
- Type 1 Diabetes, Pregnancy
- Being tested
- Automated Insulin Delivery (AID)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Insulin Delivery (AID)Device
The AID control algorithm, that will be used during the study employs a model-based predictive control algorithm to forecast future glucose levels. This predictive model accounts for the impact of delivered insulin, user-entered carbohydrates, and incorporates two short-term adaptations: "glucose momentum" and "retrospective correction." These features work to optimize glucose management with precision. The impact of carbohydrates is calculated based on the user-defined insulin-to-carbohydrate ratio and insulin sensitivity factor (ISF), while the insulin effect is governed by the ISF itself. The system then dynamically adjusts insulin delivery, aiming to bring glucose levels in line with the midpoint of the user's personalized glucose target range. Loop fine-tunes insulin delivery by increasing or decreasing the basal insulin rate, as needed, each time a new CGM value is received.
| Study group | Role | What they receive |
|---|---|---|
| AID and CGM | Experimental | Not described Receives: Device: Automated Insulin Delivery (AID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range 60-140 mg/dL per night
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 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 DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, University of Colorado, Denver, Stanford University
- Responsible party
- Principal investigator, Yogish C. Kudva, Mayo Clinic
- Investigators
- Yogish C. Kudva, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808385
- Sponsor's protocol ID
- 25-011927
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Intervention Trial of DEKA TWIIST TM Insulin Pump Utilizing Tidepool Loop Algorithm in Pregnant People With Pre-existing Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07808385
- Acronym / sponsor ID
- 25-011927
- Conditions
- Type 1 Diabetes, Pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, University of Colorado, Denver, Stanford University
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Sep 2026 (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.
Suboptimal glycemic control during pregnancy contributes to adverse maternal and fetal health outcomes and previous automated insulin delivery (AID) studies have demonstrated improvement in glucose control across all ages and sexes irrespective of past treatment modality or diabetes duration with no increase in hypoglycemia. However, very few studies evaluating AID system use in pregnancy have been performed in the US and no AID systems are currently approved for use during pregnancy. The objective of this trial is to evaluate the safety and efficacy of THE TWIIST™ system that enables the selection of pregnancy-specific glucose targets. This phase 3 pivotal trial will assess the system's performance in pregnant people with pre-existing type 1 diabetes in the US, starting as early as pregnancy confirmation, continuing throughout the pregnancy including delivery and up to 6 weeks post-partum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AID and CGM | Experimental | Device: Automated Insulin Delivery (AID) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Singleton pregnancy is confirmed by ultrasound.
- Pregnant woman between pregnancy confirmation to 96/7 weeks gestation.
- Clinical diagnosis of T1D for 1 year or longer.
- Using insulin pump (AID/SAP) or multiple daily insulin injections at screening visit.
- Willing to use U100 aspart (Novolog) or lispro (Humalog) insulin during the study.
Key exclusion criteria (26 listed)
- Individuals with T2D, gestational diabetes, or other types of diabetes (e.g., CFRD, MODY, etc.).
- Use of basal insulin alone.
- Use of short-acting insulin alone, unless use is through an insulin pump.
- Severe allergy to medical grade adhesives within the last 3 months that would inhibit participant ability to wear the study devices.
- Significant maternal and/or fetal complications, such as pre-existing heart disease (untreated or unstable cardiac diseases), pre-existing severe kidney (eGFR < 45) disease and any other condition that limits participant safety as per investigator discretion.
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)The AID control algorithm, that will be used during the study employs a model-based predictive control algorithm to forecast future glucose levels. This predictive model accounts for the impact of delivered insulin, user-entered carbohydrates, and incorporates two short-term adaptations: "glucose momentum" and "retrospective correction." These features work to optimize glucose management with precision. The impact of carbohydrates is calculated based on the user-defined insulin-to-carbohydrate ratio and insulin sensitivity factor (ISF), while the insulin effect is governed by the ISF itself. The system then dynamically adjusts insulin delivery, aiming to bring glucose levels in line with the midpoint of the user's personalized glucose target range. Loop fine-tunes insulin delivery by increasing or decreasing the basal insulin rate, as needed, each time a new CGM value is received. | Device | AID and CGM |
Primary outcome
Time in Range 60-140 mg/dL per night
Time frame: 30 weeks
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 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Yogish C. Kudva, MBBS principal investigator
Mayo Clinic
4 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) in people with Type 1 Diabetes and Pregnancy, run by Mayo Clinic at 4 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 12 inclusion and 26 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Chloe Miller, BS (507-255-0316, miller.Chloe4@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range 60-140 mg/dL per night (time frame: 30 weeks). 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 8 Sep 2026.