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

Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04617795

Enrollment

Registered

2020-11-05

Start date

2020-11-23

Completion date

2022-03-06

Last updated

2025-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

T2D, Omnipod

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

Interventions

DEVICEOmnipod 5 Automated Insulin Delivery System

The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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
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
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
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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Basal-Bolus (Group A) * 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 Omnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.	12
Basal (Group B) * 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 Omnipod 5 Automated Insulin Delivery System: The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM). The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values. The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.	12
Total	24

Withdrawals & dropouts

Period	Reason	FG000	FG001
Main Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	Total	Basal-Bolus (Group A)	Basal (Group B)
Age, Continuous	60.6 years STANDARD_DEVIATION 8.1	61.7 years STANDARD_DEVIATION 8.6	59.4 years STANDARD_DEVIATION 7.5
BMI	33.54 kg/m^2 STANDARD_DEVIATION 4.44	35.19 kg/m^2 STANDARD_DEVIATION 4.53	31.88 kg/m^2 STANDARD_DEVIATION 3.84
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	2 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants	10 Participants	10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	8 Participants	5 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	15 Participants	6 Participants	9 Participants
Sex: Female, Male Female	12 Participants	6 Participants	6 Participants
Sex: Female, Male Male	12 Participants	6 Participants	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 12	0 / 12	0 / 10
other Total, other adverse events	1 / 12	3 / 12	6 / 12	2 / 10
serious Total, serious adverse events	0 / 12	1 / 12	2 / 12	1 / 10

Outcome results

Primary

Hyperglycemia

Overall percentage of time ≥250 mg/dL during standard therapy phase and ALL phases of Automated Mode

Time frame: 8-10 weeks and after 6-month optional extension

Population: In Group B, only 10 subjects completed the extension study.

Arm	Measure	Group	Value (MEAN)	Dispersion
Basal-Bolus (Group A)	Hyperglycemia	Overall ST	21.5 Percent of Time (%)	Standard Deviation 16.8
Basal-Bolus (Group A)	Hyperglycemia	Overall AUTO	9.3 Percent of Time (%)	Standard Deviation 5.6
Basal-Bolus (Group A)	Hyperglycemia	Overall Extension	12.4 Percent of Time (%)	Standard Deviation 11.1
Basal (Group B)	Hyperglycemia	Overall AUTO	11.7 Percent of Time (%)	Standard Deviation 11.3
Basal (Group B)	Hyperglycemia	Overall ST	33.3 Percent of Time (%)	Standard Deviation 23.8
Basal (Group B)	Hyperglycemia	Overall Extension	6.4 Percent of Time (%)	Standard Deviation 4.8

Primary

Hypoglycemia

Overall percentage of time \<54 mg/dL during standard therapy phase and all phases of Automated Mode

Time frame: 8-10 weeks and after 6-month optional extension

Population: In Group B, only 10 subjects completed the extension study.

Arm	Measure	Group	Value (MEAN)	Dispersion
Basal-Bolus (Group A)	Hypoglycemia	Overall Extension	0.02 Percent of Time (%)	Standard Deviation 0.02
Basal-Bolus (Group A)	Hypoglycemia	Overall ST	0.19 Percent of Time (%)	Standard Deviation 0.36
Basal-Bolus (Group A)	Hypoglycemia	Overall AUTO	0.05 Percent of Time (%)	Standard Deviation 0.09
Basal (Group B)	Hypoglycemia	Overall AUTO	0.01 Percent of Time (%)	Standard Deviation 0.02
Basal (Group B)	Hypoglycemia	Overall Extension	0.04 Percent of Time (%)	Standard Deviation 0.05
Basal (Group B)	Hypoglycemia	Overall ST	0.02 Percent of Time (%)	Standard Deviation 0.07

Secondary

Change in Hemoglobin A1c (HbA1c)

Measures average blood sugar levels over the past 3 months

Time frame: 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

Population: In Group B, only 10 participants completed the extension.

Arm	Measure	Group	Value (MEAN)	Dispersion
Basal-Bolus (Group A)	Change in Hemoglobin A1c (HbA1c)	Baseline	9.4 Percentage of HbA1C	Standard Deviation 1
Basal-Bolus (Group A)	Change in Hemoglobin A1c (HbA1c)	End of Main Study	8.1 Percentage of HbA1C	Standard Deviation 0.8
Basal-Bolus (Group A)	Change in Hemoglobin A1c (HbA1c)	End of Extension	8.0 Percentage of HbA1C	Standard Deviation 0.7
Basal (Group B)	Change in Hemoglobin A1c (HbA1c)	End of Extension	7.5 Percentage of HbA1C	Standard Deviation 0.6
Basal (Group B)	Change in Hemoglobin A1c (HbA1c)	Baseline	9.5 Percentage of HbA1C	Standard Deviation 0.8
Basal (Group B)	Change in Hemoglobin A1c (HbA1c)	End of Main Study	8.1 Percentage of HbA1C	Standard Deviation 0.6

Secondary

Coefficient of Variation (of Glucose)

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.