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New smart insulin pump could simplify diabetes management

NCT ID NCT06853990

Disease control Sponsor: Deka Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed trial tested a new automated insulin delivery system called twiist in 307 adults with insulin-treated type 2 diabetes. The system combines an insulin pump, a continuous glucose monitor, and a smart algorithm to automatically adjust insulin. The main goal was to see if it improves blood sugar control (HbA1c) compared to the participants' usual insulin therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
twiist insulin delivery system (insulin pump, CGM sensor, and algorithm)
What this could lead to
If it works, this could offer a more convenient and effective way to manage blood sugar for people with type 2 diabetes who need insulin.
What could go wrong
This is a single-arm trial without a comparison group, so results may not be definitive. The device may not work for everyone or could have technical issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

307 people

The number who actually took part.

Started

Apr 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insulin treated type 2 diabetes mellitus Type 2 diabetes

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Diabetes & Endocrine Treatment Specialists

    Sandy City, Utah, 84093, United States

  • Emory University

    Atlanta, Georgia, 30303, United States

  • Endeavor Health

    Skokie, Illinois, 60077, United States

  • Endocrine Research Solutions, Inc

    Roswell, Georgia, 30076, United States

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • IU Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • International Diabetes Center - Health Partners Institute

    Minneapolis, Minnesota, 55416, United States

  • Iowa Diabetes & Endocrinology Research Center

    West Des Moines, Iowa, 50265, United States

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Naomi Berrie Diabetes Center

    New York, New York, 10032, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Rocky Mountain Clinical Research, LLC

    Idaho Falls, Idaho, 83404, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93111, United States

  • Scripps Whittier Diabetes Institute

    La Jolla, California, 92037, United States

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37411, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Miami

    Miami, Florida, 33146, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington

    Seattle, Washington, 98109, United States

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