A Single-Arm Trial with an Innovative Automated Insulin Delivery System for Type 2 Diabetes

Investigating an Automated Insulin Delivery System for Type 2 Diabetes

V
Viral Shah

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
5 participants needed
4 Locations

Brief description of study

The goal of this clinical trial is to learn if the twiist insulin delivery system works to treat adults with insulin-treated type 2 diabetes.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

This is a multi-center 13-week single-arm clinical trial of adults (≥18 years) with insulin-treated type 2 diabetes (T2D) to evaluate the safety and efficacy of a patient-friendly, highly accurate novel hybrid closed loop insulin pump system (twiist insulin delivery system [“twiist”]) compared with insulin delivery by open-loop insulin pump or insulin injection plus continuous glucose monitoring (CGM).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type 2 Diabetes, T2D
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria:

  1. Age >18 years old at the time of screening (date informed consent form signed)
  2. Clinical diagnosis of type 2 diabetes based on investigator assessment of at least 6 months duration at time of screening.
  3. Using one of the following insulin regimens for at least 13 weeks prior to screening: (1) basal-bolus insulin therapy with at least one injection containing rapid-acting insulin per day, (2) open-loop insulin pump, (3) premixed insulin with a rapid component, (4) basal insulin without bolus insulin.
  4. If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that can have a meaningful effect on glycemia, dose has been stable for at least 4 weeks prior to screening in the judgement of the investigator, and there are no plans to change the dose during the duration of the study. If not using glucose-lowering or weight-reduction medications that can have a meaningful effect on glycemia, participant agrees to not initiate such medications during the duration of the study.
  5. Willing and able to use only insulin approved for use in the study pump.
  6. Has the ability to read and understand written English or another language available as an option for the pump's user interface.
  7. Investigator believes that the participant has the cognitive capacity to provide informed consent.
  8. Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study.

    a. This includes considering the potential impact of medical conditions known to be present including cardiovascular, liver, kidney disease, thyroid disease, adrenal disease, malignancies, vision difficulties, active proliferative retinopathy, and other medical conditions; psychiatric conditions including eating disorders; drug or alcohol abuse.

  9. Willing to participate in the study meal and exercise challenges and have a care partner willing to be trained in hypoglycemia treatment guidelines present during and immediately after the exercise challenges (not required if exercise sessions will be done in clinic).
  10. Participants capable of becoming pregnant must meet one of the following criteria:

    a. Has a negative urine pregnancy test and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening until last follow-up visit. The following contraceptive measures are considered adequate: i. Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).

ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).

iii. Placement of an intrauterine device or intrauterine hormone-releasing system.

iv. Bilateral tubal occlusion. v. Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository).

vi. Has a vasectomized or sterile partner (where partner is sole partner of subject) and where vasectomy has been confirmed by medical assessment.

vii. Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.

or b. Participant is of non-childbearing potential due to menopause with at least one year since last menses or a medical condition confirmed by the investigator.

Exclusion Criteria:

  1. Type 1 diabetes
  2. Use of an FDA-approved or non-FDA approved closed-loop or hybrid closed-loop insulin delivery system within the past 3 months.
  3. Pregnancy (as demonstrated by a positive test) or breast-feeding at time of screening or planning to become pregnant during the next 4 months.
  4. Concomitant disease or condition that in the opinion of the investigator may compromise patient safety including but not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits.
  5. Current use of implantable CGM sensor (e.g., Senseonics)
  6. Current use of at least 500 mg of ascorbic acid (Vitamin C)
  7. Presence of a hemoglobinopathy or other condition that is expected to affect the measurement of HbA1c in the judgment of the investigator.
  8. Immediate family member (spouse, child, sibling, parent) of any person at an investigative site who is directly affiliated with this study or who is an employee of Sequel Med Tech, Millyard Advanced Medical Products LLC, Merrimack Manufacturing, or DEKA Research and Development Corp.
  9. More than 2 severe hypoglycemic events requiring third party help or hospitalization within the last 6 months prior to screening
  10. More than one DKA or HHS event within the last 6 months prior to screening
  11. Lack of reliable telephone or internet service (for contact)
  12. Known allergy to medical grade adhesives or skin condition that precludes use of the study pump or CGM
  13. Current participation in another diabetes-related interventional clinical trial.
  14. Anticipated change of residency or travel for more than 14 days at a time during the study that may, per investigator judgment, interfere with the completion of study visits, contacts, or procedures.
  15. Feasibility Phase only: Clarke Hypoglycemia Awareness Survey score of 4 or greater.

Updated on 14 Jul 2025. Study ID: ENDO-JAEB-TWIIST-T2D, 27252

This study investigates the use of an automated insulin delivery system for adults with Type 2 diabetes who are already using insulin. The purpose is to evaluate the safety and effectiveness of a hybrid closed-loop insulin pump system, which is compared to traditional methods like open-loop insulin pumps or insulin injections with continuous glucose monitoring (CGM). Type 2 diabetes is a condition where the body does not use insulin properly, leading to higher blood sugar levels.

Participants will use the insulin delivery system and undergo various study procedures, including meal and exercise challenges. The system is designed to automatically adjust insulin delivery based on glucose levels, which is different from standard insulin pumps that require manual adjustments. Participants will be monitored for safety and the system's effectiveness in managing blood sugar levels.

  • Who can participate: Adults aged 18 or older with a clinical diagnosis of Type 2 diabetes for at least 6 months are eligible. Participants must use specific insulin regimens, operate study devices, and adhere to the protocol.
  • Study details: Participants will use the automated insulin delivery system and participate in study-related activities, such as meal and exercise challenges. The study involves using only the insulin approved for the study pump.
  • Study timelines: The study will last 13 weeks.
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only