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Single Arm Intervention Trial of DEKA TWIIST TM Insulin Pump Utilizing Tidepool Loop Algorithm in Pregnant People With Pre-existing Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and well the TWIIST insulin pump with Tidepool Loop software works during pregnancy. It is for pregnant people who already have type 1 diabetes and follows them through delivery and up to 6 weeks after birth.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have one baby confirmed by ultrasound, and join by 9 weeks and 6 days of pregnancy.
  • Have had type 1 diabetes for at least 1 year and use an insulin pump or several daily insulin shots.
  • Agree to use U100 Novolog or Humalog insulin.
  • Agree to enter all carbs you eat into the system, except carbs used to treat or prevent low blood sugar.
  • Have no major health problems affecting you or the baby when you join.
  • Agree to follow study rules, learn to use study devices, and receive routine and specialist pregnancy care.
  • Speak and understand English and be able to give informed consent.
  • Have an adult care partner staying with you or within 40 miles who can learn the devices and follower app, treat high or low blood sugar, and get emergency help.

Who can't join

  • Have a type of diabetes other than type 1, carry more than one baby, or use only long-acting insulin or only short-acting insulin without a pump.
  • Have major pregnancy problems, serious heart or kidney disease, advanced diabetes damage to nerves or eyes, or severe problems with the stomach emptying.
  • Have a bleeding disorder, low adrenal hormone levels, thyroid tests that stay abnormal after medicine changes, current cancer treatment, or an organ transplant.
  • Had very low blood sugar or diabetic ketoacidosis (dangerous acid buildup) needing a hospital stay in the past 3 months, or more than one ketoacidosis episode in the past year.
  • Need at least 1.5 units of insulin per kilogram of body weight daily, have a body mass index above 40, or have a known or suspected insulin allergy.
  • Use insulin that is not allowed and will not switch; use other blood sugar medicines besides metformin and will not stop; or use oral steroids now, long-term, or high-dose steroids within the past 2 months.
  • Have a recent severe allergy to medical adhesives, major skin problems where devices attach, or vision or hearing loss that prevents device use; or will not wear the study pump.
  • Lack needed phone or computer access, plan a move that prevents study visits, take part in another drug or device treatment study, or have another condition the study doctor thinks makes participation unsafe or affects the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.

Study sites (4)

CA

CO

MN

NY