RECRUITING

Innovative Automated Insulin Delivery System for Type 2 Diabetes

Conditions

Type 2 Diabetes Insulin Treated Type 2 Diabetes Mellitus automated insulin delivery system (AID)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Single-arm Trial With an Innovative Automated Insulin Delivery System for Type 2 Diabetes ("Twiist-T2D")

Quick Facts

Study Start:2025-04-14

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06853990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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:	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.

Inclusion Criteria

Exclusion 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.
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:

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.

Contacts and Locations

Study Locations (Sites)

Scripps Whittier Diabetes Institute

La Jolla, California, 92037

United States

Sansum Diabetes Research Institute

Santa Barbara, California, 93111

United States

Endocrine Research Solutions, Inc

Roswell, Georgia, 30076

United States

Rocky Mountain Clinical Research, LLC

Idaho Falls, Idaho, 83404

United States

Endeavor Health

Skokie, Illinois, 60077

United States

Joslin Diabetes Center

Boston, Massachusetts, 02215

United States

Henry Ford Health

Detroit, Michigan, 48202

United States

International Diabetes Center - Health Partners Institute

Minneapolis, Minnesota, 55416

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Naomi Berrie Diabetes Center

New York, New York, 10032

United States

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, 78731

United States

Collaborators and Investigators

Sponsor: Deka Research and Development

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-14

Study Completion Date2026-06

Study Record Updates

Study Start Date2025-04-14

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

automated insulin delivery system (AID)

Additional Relevant MeSH Terms

Type 2 Diabetes
Insulin Treated Type 2 Diabetes Mellitus