Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes, T2D, Omnipod 5, Automated Insulin Delivery System
Brief summary
This is a single arm feasibility study to evaluate the Omnipod M System in adults with Type 2 Diabetes with the aim to enroll to 40 participants aged 18-75 years with type 2 diabetes to have a minimum of 20 participants initiate the use of Omnipod M System and the goal of 16 participants completing the 6-week treatment period.
Interventions
DEVICEOmnipod M system
The Omnipod M system will allow user to use a lower glucose target and improve systems glucose control
Sponsors
Insulet Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age at time of consent 18-75 years (inclusive) 2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening 3. On current insulin regimen for at least 3 months prior to screening (i.e. basal-bolus, basal insulin only or premix) 4. Basal-bolus (AID or non-AID pump \& MDI) or premix users with A1C \< 14% OR basal users on long or intermediate acting insulin only with A1C \> 8.0% and \< 14% 5. 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 6. Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities 7. If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, 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. 8. Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol 9. Willing to wear the system, including Pods, continuously throughout the study 10. Willing and able to sign the Informed Consent Form (ICF) 11. Able to read and understand English 12. If of childbearing potential, willing and able to have pregnancy testing
Exclusion criteria
1. Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse. 2. Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening 3. Any planned surgery during the study which could be considered major in the opinion of the Investigator 4. History of more than 1 severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions 5. History of more than 1 diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis 6. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement 7. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c 8. Use of hydroxyurea 9. Plans to receive blood transfusion over the course of the study 10. Pregnant or lactating, or is of childbearing potential and not using an 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); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal). 11. Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study 12. 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 13. 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 14. Participant is an employee of Insulet, an Investigator or a member of Investigator's study team, or immediate family member of any of the aforementioned
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of time in hypoglycemic range <70mg/dL | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system |
| Percent of time in hyperglycemic range >180 mg/dL | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Glucose | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system |
| Percentage of time <54 mg/dL | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system |
| Percentage of time >250mg/dL | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system |
| Percentage of time >300mg/dL | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system |
| Percent of time between 70-180mg/dL | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system |
| Standard Deviation | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) |
| Coefficient of Variation | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV) |
| Average total daily insulin (TDI) | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system |
| Average TDI/kg | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system |
| Change in weight | Comparing baseline metrics to the end of the treatment period (Day45) | measures change in weight |
| Patient reported outcomes | Comparing baseline metrics to the end of the treatment period (Day45) | Participant responses to various questionnaires related to the investigational device as well as managing diabetes |
| 4-hour post prandial glycemic metrics | Comparing baseline metrics to the end of the treatment period (Day45) | Glucose metric from study continuous glucose monitoring system |
Countries
United States
Outcome results
None listed