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| Name | Class |
|---|---|
| Sequel Med Tech | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| twiist users | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| twiist insulin delivery system | Device | twiist system includes a novel insulin pump, a CGM sensor and the DEKA Loop algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
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Inclusion Criteria:
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).
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Whittier Diabetes Institute | La Jolla | California | 92037 | United States | ||
| Hoag Memorial Hospital Presbyterian |
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| Baseline to 13-weeks |
| Newport Beach |
| California |
| 92663 |
| United States |
| Sansum Diabetes Research Institute | Santa Barbara | California | 93111 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| University of Miami | Miami | Florida | 33146 | United States |
| Emory University | Atlanta | Georgia | 30303 | 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 |
| IU Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Iowa Diabetes & Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
| International Diabetes Center - Health Partners Institute | Minneapolis | Minnesota | 55416 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | 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 |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University Diabetes & Endocrine Consultants | Chattanooga | Tennessee | 37411 | United States |
| Texas Diabetes & Endocrinology, P.A. | Austin | Texas | 78731 | United States |
| Diabetes & Endocrine Treatment Specialists | Sandy City | Utah | 84093 | United States |
| University of Washington | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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