Clinical trial NCT04617795: Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
Official title: Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: T2D
Omnipod
Lead sponsor: Insulet Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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

Eligibility criteria: Inclusion Criteria:

1. Age at time of consent 18-75 years
2. Diagnosed with type 2 diabetes on insulin therapy by injection: basal-bolus (12 subjects) or basal only (12 subjects) regimens
3. A1C 8.0-12.0%
4. Has not used an insulin pump within 3 months of screening
5. Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study
6. Maximum insulin dose of 200 units/day
7. Stable doses over the last 4 weeks of other glucose-lowering medications as determined by Investigator
8. Willing to wear the system continuously throughout the study
9. Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
10. Investigator has confidence that the subject has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
11. 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
12. 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
13. Able to read and speak English fluently
14. Willing and able to sign the Informed Consent Form (ICF)

Exclusion Criteria:

1. A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
2. Planned major surgery during the study
3. History of severe hypoglycemia in the past 6 months
4. History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
5. Diagnosed with a blood dyscrasia or bleeding disorder
6. Plans to receive blood transfusion over the course of the study
7. Currently diagnosed with anorexia nervosa or bulimia
8. Currently on hemodialysis
9. History of adrenal insufficiency
10. Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the study
11. Unable to tolerate adhesive tape or has any unresolved skin condition in sensor or pump placement
12. Plans to use insulin other than U-100 insulin during the Omnipod 5 phase of the study
13. 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.
14. 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)
15. 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
16. 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

Primary outcomes:
measure: Hyperglycemia
timeFrame: 8-10 weeks and after 6-month optional extension
measure: Hypoglycemia
timeFrame: 8-10 weeks and after 6-month optional extension
Secondary outcomes:
measure: Percent of Time in Range 70-180 mg/dL
timeFrame: 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: Percent of Time > 180 mg/dL
timeFrame: 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: Percent of Time ≥ 300 mg/dL
timeFrame: 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: Percent of Time < 70 mg/dL
timeFrame: 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: Standard Deviation
timeFrame: 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: Coefficient of Variation (of Glucose)
timeFrame: 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: Mean Glucose
timeFrame: 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: Total Daily Insulin (Units)
timeFrame: 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: Total Daily Insulin (Units/kg)
timeFrame: 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: Change in Hemoglobin A1c (HbA1c)
timeFrame: 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
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Diabetes
state: Georgia
city: Saint Louis Park
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Anders Carlson, MD
role: STUDY_CHAIR
affiliation: Keck School of Medicine of USC
name: Anne Peters, MD
role: STUDY_CHAIR
References: