Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Insulet Corporation
- Enrollment
- 25
- Locations
- 4
- Primary Endpoint
- Hyperglycemia
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The study subjects will be separated into 2 groups, depending on their previous insulin therapy with approximately 50% of subjects from each group, continuous glucose monitoring (CGM) naive.
Group A will complete a 2-week Standard Therapy Phase followed by 8 weeks of Omnipod 5 system use.
Group B will complete a 2-week Standard Therapy Phase followed by 10 weeks of Omnipod 5 system use.
Group A and Group B will have an optional 6-month extension of Omnipod 5 system use
Detailed Description
Basal-Bolus - Group A (N=12) * 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 continuous glucose monitoring (CGM) , followed by: * 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by: * 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus * 6-month optional extension using Automated Mode Basal - Group B (N=12) * 2 weeks standard therapy - using basal injection only and Dexcom G6 continuous glucose monitoring (CGM) , followed by: * 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 continuous glucose monitoring (CGM) - with fixed basal rate, no bolus, followed by: * 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by: * If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR * If % time in range 70-180 mg/dL during Automated Mode is \>50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus * 6-month optional extension using Automated Mode
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age at time of consent 18-75 years
- •Diagnosed with type 2 diabetes on insulin therapy by injection: basal-bolus (12 subjects) or basal only (12 subjects) regimens
- •A1C 8.0-12.0%
- •Has not used an insulin pump within 3 months of screening
- •Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study
- •Maximum insulin dose of 200 units/day
- •Stable doses over the last 4 weeks of other glucose-lowering medications 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 subject has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
Exclusion Criteria
- •A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
- •Planned major surgery during the study
- •History of severe hypoglycemia in the past 6 months
- •History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
- •Diagnosed with a blood dyscrasia or bleeding disorder
- •Plans to receive blood transfusion over the course of the study
- •Currently diagnosed with anorexia nervosa or bulimia
- •Currently on hemodialysis
- •History of adrenal insufficiency
- •Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the study
Outcomes
Primary Outcomes
Hyperglycemia
Time Frame: 8-10 weeks and after 6-month optional extension
Overall percentage of time ≥250 mg/dL during standard therapy phase and ALL phases of Automated Mode
Hypoglycemia
Time Frame: 8-10 weeks and after 6-month optional extension
Overall percentage of time \<54 mg/dL during standard therapy phase and all phases of Automated Mode
Secondary Outcomes
- Percent of Time in Range 70-180 mg/dL(Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B)
- Percent of Time > 180 mg/dL(Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B)
- Percent of Time ≥ 300 mg/dL(Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B)
- Percent of Time < 70 mg/dL(Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B)
- Standard Deviation(Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B)
- Coefficient of Variation (of Glucose)(Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B)
- Mean Glucose(Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B)
- Total Daily Insulin (Units)(Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B)
- Total Daily Insulin (Units/kg)(Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B)
- Change in Hemoglobin A1c (HbA1c)(End of study (8-10 weeks) and during extension (21-23 weeks and 24-26 weeks) compared to baseline (Days 57, 147, and 237 (Group A) or Days 71, 161, and 251 (Group B) compared to Day -30)