Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Conditions
Keywords
Omnipod, Automated Insulin Delivery, T2D, T1D, Type 2 Diabetes, Type 1 Diabetes, AID
Brief summary
This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.
Detailed description
Following a 2-week standard therapy phase for baseline data collection, participants will be randomly assigned to the order in which they receive Omnipod 6 or Omnipod 5. After completion of the first 13-week period, participants will cross-over to the opposite system for an additional 13 weeks. An optional 4-week extension will be offered to all participants to assess the response of the Omnipod 6 System with restricted boluses
Interventions
DEVICEOmnipod 5 System
The Omnipod 5 System with the study CGM
DEVICEOmnipod 6 System
The Omnipod 6 System with the study CGM
Sponsors
Insulet Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age at time of consent 14-75 years (inclusive) * Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment * Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation * HbA1c ≥ 7.5% * Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user * Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user * Currently using a continuous glucose monitor * Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents. * Participant agrees to provide their own insulin for the duration of the study * Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol * Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol * If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes. * Willing to wear the system continuously throughout the study * Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from adolescent participants aged \< 18 years per local regulatory requirements * Able to read and understand English and operate the study device in English * If of childbearing potential, willing and able to have pregnancy testing
Exclusion criteria
* Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk * Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, 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 judgment of the investigator * History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions. * History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure * Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement * Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c * Use of hydroxyurea * Plans to receive blood transfusion over the course of the study * Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study * Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening. * Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening * Pregnant or lactating, or of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner). * Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this 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 of any of the aforementioned
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range 70-180 mg/dL | 13 weeks | Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5 |
| Time <54 mg/dL | 13 weeks | Change in CGM percent time \<54 mg/dL compared between Omnipod 6 and Omnipod 5 |
| Time <70 mg/dL | 13 weeks | Change in CGM percent time \<70 mg/dL compared between Omnipod 6 and Omnipod 5 |
| Time >180 mg/dL | 13 weeks | Change in CGM percent time \>180 mg/dL compared between Omnipod 6 and Omnipod 5 |
| Time in Range 70-140 mg/dL | 13 weeks | Change in CGM percent time 70-140 mg/dL compared between Omnipod 6 and Omnipod 5 |
| HbA1c | 13 weeks | Change in HbA1c (%) between Omnipod 6 and Omnipod 5 |
| Mean sensor glucose | 13 weeks | Change in mean CGM glucose mg/dL compared between Omnipod 6 and Omnipod 5 |
| Time >250 mg/dL | 13 weeks | Change in CGM percent time \>250 mg/dL compared between Omnipod 6 and Omnipod 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total boluses per day | 13 weeks | Total blues per day will be compared between Omnipod 6 and Omnipod 5 |
| Total daily insulin per kg and total insulin delivered via automation | 13 weeks | Total daily insulin per kg and total insulin delivered via automation will be compared between Omnipod 6 and Omnipod 5 |
| Percentage of time in automated mode | 13 weeks | Percentage of time in automated mode will be compared between Omnipod 6 and Omnipod 5 |
| Percentage with HbA1c <7.0% and <7.5% | 13 weeks | Percentage with HbA1c \<7.0% and \<7.5% will be compared between Omnipod 6 and Omnipod 5 |
| Percentage with >= 70% time in range | 13 weeks | Percentage with \>= 70% time in range will be compared between Omnipod 6 and Omnipod 5 |
| Percentage with >= 50% time in range | 13 weeks | Percentage with \>= 50% time in range will be compared between Omnipod 6 and Omnipod 5 |
| Diabetes treatment satisfaction | 13 weeks | Patient Reported Outcome with treatment period comparison and baseline to Omnipod 6 |
| System Usability | 13 weeks | Patient Reported Outcome Survey evaluated at the end of each 13-week period |
| System Opinion | 13 weeks | Patient Reported Outcome Survey evaluated at the end of each 13-week period |
| Health Related Quality of Life (HR-QOL) | 13 weeks | Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6 |
| Hypoglycemia confidence | 13 weeks | Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6 |
| Missed Meal - Peak glucose | 13 weeks | Peak glucose 4-hours post-prandial compared between Omnipod 6 and Omnipod 5 |
| Missed Meal - AUC | 13 weeks | AUC 4-hours post-prandial compared between Omnipod 6 and Omnipod 5 |
| Missed Meal - Time in Range | 13 weeks | Time in Range 4-hours post-prandial compared between Omnipod 6 and Omnipod 5 |
| Missed Meal - Percentage of Time > 180 mg/dL | 13 weeks | Percentage of Time \> 180 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5 |
| Missed Meal - Percentage of Time > 250 mg/dL | 13 weeks | Percentage of Time \> 250 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5 |
| Missed Meal - Percentage of Time <54 mg/dL | 13 weeks | Percentage of Time \<54 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5 |
| Missed Meal - Percentage of Time <70 mg/dL | 13 weeks | Percentage of Time \<70 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5 |
| Number of severe hypoglycemic events | 13 weeks | — |
| Number of DKA or HHS events | 13 weeks | — |
| Other related serious adverse events | 13 weeks | — |
| Unanticipated adverse device effects | 13 weeks | — |
| Reportable device-related adverse events | 13 weeks | — |
Countries
United States
Contacts
CONTACTTrang Ly, MBBS, PhD
CONTACTBonnie Dumais, RN
Outcome results
None listed