Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes

Not Applicable

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Device: Omnipod 5 Automated Insulin Delivery System

Registration Number: NCT04617795

Lead Sponsor: Insulet Corporation

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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
Must be willing to use the Dexcom App on the Omnipod 5 PDM as the sole source of Dexcom data (except for the Dexcom Follow App) during Automated Mode
Subjects scoring ≥ 4 on the Clarke Questionnaire must agree to have an overnight companion, defined as someone who resides in the same home or building as the study subject and who can be available overnight
Able to read and speak English fluently
Willing and able to sign the Informed Consent Form (ICF)

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
Unable to tolerate adhesive tape or has any unresolved skin condition in sensor or pump placement
Plans to use insulin other than U-100 insulin during the Omnipod 5 phase of the study
Cardiac disease with functional status New York Heart Association Class III or IV or 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 previous 12-months.
Pregnant or lactating, 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)
Participation in another clinical study using an investigational drug or device other than the Omnipod 5 in the preceding 30-days 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Basal-Bolus (Group A)	Omnipod 5 Automated Insulin Delivery System	* 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (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)	Omnipod 5 Automated Insulin Delivery System	* 2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by: * 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (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

Primary Outcome Measures

Name	Time	Method
Hyperglycemia	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	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 Outcome Measures

Name	Time	Method
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	Glucose metric from study continuous glucose monitoring system
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	Glucose metric from study continuous glucose monitoring system
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	Glucose metric from study continuous glucose monitoring system
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	Glucose metric from study continuous glucose monitoring system
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	Glucose metric from study continuous glucose monitoring system-measured glucose variability with the standard deviation
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	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.
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	Glucose metric from study continuous glucose monitoring system
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	Measure of insulin requirements
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	Measure of insulin requirements
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	Measures average blood sugar levels over the past 3 months

Trial Locations

Locations (4): Emory University
🇺🇸
Atlanta, Georgia, United States
University of California
🇺🇸
Los Angeles, California, United States
Atlanta Diabetes
🇺🇸
Atlanta, Georgia, United States
International Diabetes Center
🇺🇸
Saint Louis Park, Minnesota, United States