Innovative Automated Insulin Delivery System for Type 2 Diabetes

NCT06853990 | Active Not Recruiting DMC FDA Device

• 1 other identifier: DKPI-00730-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 30

Brief 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.

Conditions

Type 2 Diabetes; Insulin Treated Type 2 Diabetes Mellitus

Keywords

automated insulin delivery system (AID)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 13-weeks

Secondary Outcomes (1)

• CGM-measured time in and out of range

  Baseline to 13-weeks

Study Arms (1)

twiist users

EXPERIMENTAL

Device: twiist insulin delivery system

Interventions

twiist insulin delivery system DEVICE

twiist system includes a novel insulin pump, a CGM sensor and the DEKA Loop algorithm

twiist users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• 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:
• 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).

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Deka Research and Development: lead
• Sequel Med Tech: collaborator

Study Sites (30)

Scripps Whittier Diabetes Institute

La Jolla, California, 92037, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Sansum Diabetes Research Institute

Santa Barbara, California, 93111, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Miami

Miami, Florida, 33146, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Endocrine Research Solutions, Inc

Roswell, Georgia, 30076, United States

Location

Rocky Mountain Clinical Research, LLC

Idaho Falls, Idaho, 83404, United States

Location

Endeavor Health

Skokie, Illinois, 60077, United States

Location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Iowa Diabetes & Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

International Diabetes Center - Health Partners Institute

Minneapolis, Minnesota, 55416, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Naomi Berrie Diabetes Center

New York, New York, 10032, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, 78731, United States

Location

Diabetes & Endocrine Treatment Specialists

Sandy City, Utah, 84093, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: April 14, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)