Type 2 Diabetestwiist-T2DNCT06853990
Innovative Automated Insulin Delivery System for Type 2 Diabetes
A study testing twiist insulin delivery system in people with Type 2 Diabetes and Insulin Treated Type 2 Diabetes Mellitus, run by Deka Research and Development at 30 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Insulin Treated Type 2 Diabetes Mellitus
- What is being tested?
- twiist insulin delivery system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 30 sitesUnited States
- Study dates
- 14 Apr 2025to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old at the time of screening (date informed consent form signed)
- Clinical diagnosis of type 2 diabetes based on investigator assessment of at least 6 months duration at time of screening.
- 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.
- 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.
- Willing and able to use only insulin approved for use in the study pump.
- Has the ability to read and understand written English or another language available as an option for the pump's user interface.
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- Investigator believes that the participant has the cognitive capacity to provide informed consent.
- 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.
- 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.
- 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).
- Participants capable of becoming pregnant must meet one of the following criteria:
- 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).
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
- Placement of an intrauterine device or intrauterine hormone-releasing system.
- Bilateral tubal occlusion. v. Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository).
- Has a vasectomized or sterile partner (where partner is sole partner of subject) and where vasectomy has been confirmed by medical assessment.
- 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.
Who cannot join
- Type 1 diabetes
- Use of an FDA-approved or non-FDA approved closed-loop or hybrid closed-loop insulin delivery system within the past 3 months.
- Pregnancy (as demonstrated by a positive test) or breast-feeding at time of screening or planning to become pregnant during the next 4 months.
- 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.
- Current use of implantable CGM sensor (e.g., Senseonics)
- Current use of at least 500 mg of ascorbic acid (Vitamin C)
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- Presence of a hemoglobinopathy or other condition that is expected to affect the measurement of HbA1c in the judgment of the investigator.
- 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.
- More than 2 severe hypoglycemic events requiring third party help or hospitalization within the last 6 months prior to screening
- More than one DKA or HHS event within the last 6 months prior to screening
- Lack of reliable telephone or internet service (for contact)
- Known allergy to medical grade adhesives or skin condition that precludes use of the study pump or CGM
- Current participation in another diabetes-related interventional clinical trial.
- 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.
- Feasibility Phase only: Clarke Hypoglycemia Awareness Survey score of 4 or greater.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30303
University of Colorado
Aurora, Colorado, 80045
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731
University of Maryland
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of North Carolina
Chapel Hill, North Carolina, 27599
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37411
The Ohio State University
Columbus, Ohio, 43210
Henry Ford Health
Detroit, Michigan, 48202
Rocky Mountain Clinical Research, LLC
Idaho Falls, Idaho, 83404
IU Health University Hospital
Indianapolis, Indiana, 46202
Scripps Whittier Diabetes Institute
La Jolla, California, 92037
University of Miami
Miami, Florida, 33146
International Diabetes Center - Health Partners Institute
Minneapolis, Minnesota, 55416
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Naomi Berrie Diabetes Center
New York, New York, 10032
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Endocrine Research Solutions, Inc
Roswell, Georgia, 30076
Diabetes & Endocrine Treatment Specialists
Sandy City, Utah, 84093
Sansum Diabetes Research Institute
Santa Barbara, California, 93111
University of Washington
Seattle, Washington, 98109
Endeavor Health
Skokie, Illinois, 60077
SUNY Upstate Medical University
Syracuse, New York, 13210
Iowa Diabetes & Endocrinology Research Center
West Des Moines, Iowa, 50265
About this study
Official title: A Single-arm Trial With an Innovative Automated Insulin Delivery System for Type 2 Diabetes ("Twiist-T2D")
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.
- Being tested
- twiist insulin delivery system
- Keywords
- automated insulin delivery system (AID)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
twiist insulin delivery systemDevice
twiist system includes a novel insulin pump, a CGM sensor and the DEKA Loop algorithm
| Study group | Role | What they receive |
|---|---|---|
| twiist users | Experimental | Not described Receives: Device: twiist insulin delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
HbA1c will be tested first for non-inferiority (non-inferiority limit 0.3%) and then if non-inferiority is demonstrated, it will be tested for superiority.
Measured: Baseline to 13-weeks
Secondary outcomes (1)
CGM-measured time in and out of range
For the following endpoints, the change from baseline to follow-up will be tested in a hierarchy to control the overall type 1 error (assuming the analysis of the primary endpoint is statistically significant). Testing will be for superiority unless otherwise specified.
- CGM-measured time in range 70-180 mg/dL
- CGM-measured time in tight range 70-140 mg/dL
- CGM-measured time <54 mg/dL (non-inferiority, margin 0.5%)
- CGM-measured time <70 mg/dL (non-inferiority, margin 2.0%)
- CGM-measured mean glucose
- CGM-measured time >180 mg/dL
- CGM-measured time >250 mg/dL
- CGM-measured time <70 mg/dL
- CGM-measured time <54 mg/dL
Measured: Baseline to 13-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start14 Apr 2025
- Primary completion25 Feb 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deka Research and Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sequel Med Tech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853990
- Sponsor's protocol ID
- DKPI-00730-001
- Acronym
- twiist-T2D
- Status last verified
- Jun 2026
- First submitted
- 25 Feb 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Trial With an Innovative Automated Insulin Delivery System for Type 2 Diabetes ("Twiist-T2D")
- ClinicalTrials.gov ID
- NCT06853990
- Acronym / sponsor ID
- twiist-T2D / DKPI-00730-001
- Keywords
- automated insulin delivery system (AID)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Deka Research and DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- Sequel Med Tech
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 3 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 to learn if the twiist insulin delivery system works to treat adults with insulin-treated type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| twiist users | Experimental | Device: twiist insulin delivery system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age >18 years old at the time of screening (date informed consent form signed)
- Clinical diagnosis of type 2 diabetes based on investigator assessment of at least 6 months duration at time of screening.
- 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.
- 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.
- Willing and able to use only insulin approved for use in the study pump.
Key exclusion criteria (15 listed)
- Type 1 diabetes
- Use of an FDA-approved or non-FDA approved closed-loop or hybrid closed-loop insulin delivery system within the past 3 months.
- Pregnancy (as demonstrated by a positive test) or breast-feeding at time of screening or planning to become pregnant during the next 4 months.
- 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.
- Current use of implantable CGM sensor (e.g., Senseonics)
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 |
|---|---|---|
| twiist insulin delivery systemtwiist system includes a novel insulin pump, a CGM sensor and the DEKA Loop algorithm | Device | twiist users |
Primary outcome
Change in HbA1c
Time frame: Baseline to 13-weeks
HbA1c will be tested first for non-inferiority (non-inferiority limit 0.3%) and then if non-inferiority is demonstrated, it will be tested for superiority.
1 secondary outcome
CGM-measured time in and out of range
Time frame: Baseline to 13-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing twiist insulin delivery system in people with Type 2 Diabetes and Insulin Treated Type 2 Diabetes Mellitus, run by Deka Research and Development at 30 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 18 inclusion and 15 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: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Baseline to 13-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 2 Jun 2026.