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L'essai clinique NCT05815342 (SECURE-T2D) pour Diabète de Type 2 est terminé. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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OP5-005 Using Omnipod 5 in Adults With Type 2 (SECURE-T2D) 343 Multicentrique
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT05815342 (SECURE-T2D) a été une étude interventionnel pour Diabète de Type 2. Son statut actuel est : terminé. L'étude a commencé le 11 avril 2023, avec un objectif de recruter 343 participants. Dirigée par Insulet Corporation, l'étude s'est terminée le 1 mars 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 29 septembre 2025.
Résumé succinct
This is a single arm, multi-center, prospective study that will evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.
Description détaillée
This outpatient study consists of 2 phases.
Phase 1 is a 14-day period to collect baseline glucose and insulin data. Participants will manage their diabetes as an outpatient per their usual routine. During this time participants will wear a blinded continuous glucose monitor to collect baseline glycemic information.
Phase 2 is a 13 week treatment period during which participants will use the Omnipod 5 System consis...
Afficher plusTitre officiel
Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes
Pathologies
Diabète de Type 2Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- SECURE-T2D
- G230013
Numéro NCT
Date de début (réel)
2023-04-11
Dernière mise à jour publiée
2025-09-29
Date de fin (estimée)
2024-03-01
Inscription (estimée)
343
Type d'étude
Interventionnel
PHASE
N/A
Statut
Terminé
Mots clés
T2D
Omnipod
Automated Insulin Delivery
Omnipod
Automated Insulin Delivery
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalTreatment All subjects wearing the Omnipod 5 Automated Glucose Monitoring System | Omnipod 5 Automated Glucose Control System The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Change in HbA1c | The change in HbA1c at 13 weeks from baseline | Comparing the change in HbA1c during the 13 weeks study phase |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Mean Glucose | Glucose metric from study provided continuous glucose monitor (CGM) | Measuring mean glucose during the 13 weeks study phase |
Percentage of Time in Range 70-180 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase |
Percent of Time in Range 70-140 mg/dL | Glucose metric from study CGM | Measured during 13 weeks study phase |
Percent of Time ≥ 300 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase |
Percent of Time > 250 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase |
Percent of Time >180 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase |
Percent of Time < 70 mg/dL [Non-inferiority; Non-inferiority Limit 2.0%] | Glucose metric from CGM | Measured during 13 weeks study phase |
Percent of Time < 54 mg/dL [Non-inferiority; Non-inferiority Limit 0.5%] | Glucose metric from CGM | Measured during 13 weeks study phase |
Change From Baseline in T2-DDAS Total Score | A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome. | Baseline compared to end of week 13 visit |
Percentage Meeting MCID for T2-DDAS | A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome. | Baseline compared to end week 13 visit |
Change From Baseline in Pittsburgh Sleep Quality Index Total Score | Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items.
Minimum Score = 0 (better); Maximum Score = 21 (worse). Lower scores indicate better outcomes (eg, less distress related to diabetes, better sleep quality). | Baseline compared to end of week 13 visit |
% Meeting MCID for Pittsburgh Sleep Quality Index | Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items. | Baseline compared to end of week 13 visit |
Change From Baseline in HCS Total Score | Questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome. | Baseline compared to end week 13 visit |
% Meeting MCID for HCS | Questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome. | Baseline compared to end week 13 visit |
Percentage of Time <70 mg/dL (Superiority) | Glucose metric from CGM | Measured during 13 weeks study phase |
Percentage of Time <54 mg/dL (Superiority) | Glucose metric from CGM | Measured during 13 weeks study phase |
Coefficient of Variation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period. | Measured during 13 weeks study phase and compared to standard therapy |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- Age at time of consent 18-75 years
- Diagnosed with type 2 diabetes, on current insulin regimen for at least 3 months prior to screening (i.e. Basal-bolus, basal only or pre-mix)
- Basal bolus (long-acting insulin and rapid acting analog) or pre-mix users with A1C <12.0% OR basal users on long or intermediate acting insulin only with A1C > 7.0% and < 12.0%
- Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
- Participant agrees to provide their own insulin for the duration of the study
- Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator
- Stable doses of weight loss medications over the preceding 4 weeks and throughout the study that may affect glycemic control directly and/or indirectly, except for a dose reduction or discontinuation, as determined by Investigator
- Willing to wear the system continuously throughout the study
- Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
- Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
- Able to read and understand English or Spanish
- Willing and able to sign the Informed Consent Form (ICF)
- If female of childbearing potential, willing and able to have pregnancy testing
- Use of an AID pump in automated mode within 3 months prior to screening
- Any medical condition which in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia)
- Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
- Any planned surgery during the study which could be considered major in the opinion of the investigator
- History of more than 1 severe hypoglycemic event in the 6 months prior to screening
- History of more than 1 episode of diabetic ketoacidosis (DKA) or Hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening; unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis
- Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1c
- Plans to receive blood transfusion over the course of the study
- Has taken oral or injectable steroids within 8 weeks prior to screening or plans to take oral or injectable steroids during the study
- Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
- Pregnant or lactating, planning to become pregnant during the study, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal)
- Participation in another clinical study using an investigational drug or device other than the Omnipod 5 in the 30 days prior to screening or intends to participate during the study period
- Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment
- Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned
Insulet CorporationJaeb Center for Health ResearchAucune donnée de contact disponible
21 Centres de l'étude dans 1 pays
California
University of Southern California, Los Angeles, California, 90022, United States
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
Colorado
University of Colorado, Aurora, Colorado, 80045, United States
Florida
East Coast Institute for Research, Jacksonville, Florida, 32216, United States
Metabolic Research Institute, West Palm Beach, Florida, 33401, United States
Georgia
Emory, Atlanta, Georgia, 30303, United States
East Coast Institute for Research, Canton, Georgia, 30114, United States
Endocrine Research, Roswell, Georgia, 30076, United States
Massachusetts
Joslin Diabetes, Boston, Massachusetts, 02215, United States
Michigan
Henry Ford, Detroit, Michigan, 48202, United States
Minnesota
Health Partners, Minneapolis, Minnesota, 55416, United States
New York
Albert Einstein College of Medicine, The Bronx, New York, 10461, United States
North Carolina
MAHEC, Asheville, North Carolina, 28803, United States
University of North Carolina, Chapel Hill, North Carolina, 27514, United States
Physicians East, Greenville, North Carolina, 27834, United States
AccellaCare, Wilmington, North Carolina, 28401, United States
Ohio
Ohio State, Columbus, Ohio, 43203, United States
Tennessee
University Diabetes and Endocrine Consultants, Chattanooga, Tennessee, 37411, United States
Texas
Texas Diabetes and Endocrinology, Austin, Texas, 78731, United States
Diabetes and Thyroid Center, Fort Worth, Texas, 76132, United States
Diabetes and Glandular Disease Clinic, San Antonio, Texas, 78229, United States