This is an outpatient study testing different starting doses of insulin in participants with type 2 diabetes. Participants will manage their diabetes using the Omnipod M System. The system is comprised of an Omnipod M Pod, an Omnipod M Controller, and will be used with a Dexcom G6 continuous glucose monitoring sensor (CGM). The main objectives of the study are to evaluate the safety and tolerability of different starting doses of insulin using the Omnipod M System. There is a precursory evaluation before the main, randomized trial. Participation in the precursory evaluation could last up to 12 weeks and participation in the randomized trial could last up to 6 weeks. During both the evaluation and the randomized trial, participants will manage their diabetes using the Omnipod M System in Automated Mode. An optional 12-weeks of continued Omnipod M System use is available upon completion of the randomized trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system
Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system
University of Colorado
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
MassResearch LLC.
Waltham, Massachusetts, United States
AccellaCare
Wilmington, North Carolina, United States
Disease & Glandular Disease Clinic
San Antonio, Texas, United States
Percent of time >180 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time <70 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time in range (TIR) 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time above range (TAR) >250 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Percent of time below range (TBR) <54 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Total daily insulin (TDI)
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Total daily insulin/kg
Glucose metric from study continuous glucose monitoring system
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Perception questionnaire
Includes questions about participant's private attitudes, feelings, and behavior related to the investigational device as well as managing diabetes.
Time frame: Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial.
Weight
Measures change in weight
Time frame: Comparing baseline to end of continuation phase in the randomized trial.
HbA1c
Measures changes in HbA1c
Time frame: Comparing baseline to end of continuation phase in the randomized trial.
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