Omnipod 5 System Compared to Pump Therapy

Efficacy and Safety of the Omnipod 5 System Compared to Pump Therapy in the Treatment of Type 1 Diabetes: a Randomized, Parallel-group Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05409131

Enrollment

196

Registered

2022-06-08

Start date

2022-07-07

Completion date

2025-01-10

Last updated

2025-09-16

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

Conditions

Type 1 Diabetes

Keywords

T1D, Omnipod, Automated Insulin Delivery

Brief summary

Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system. Participants in France will be offered an optional extension of 12 months of Omnipod 5 System use.

Detailed description

This is an outpatient study that consists of two phases, Phase 1 and Phase 2. There will be approximately 8 study visits conducted in person or via telehealth. Phase 1 is a 14-day period to collect baseline sensor and insulin data where subjects will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system. Phase 2 is a 90-day period where subjects will be randomized into one of two groups. One group will use the Omnipod 5 system and the other group will continue to use their personal insulin pump with the study continuous glucose monitoring system. Following the 90-day outpatient phase, participants in France will be offered the option to transition to use the CE-marked commercial Omnipod 5 System for an additional 12 months with the French interface.

Interventions

DEVICEOmnipod 5 System

Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Age at time of consent 18-70 years of age 2. Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment. 3. On pump therapy for ≥ 3 months prior to screening and familiar with pump therapy concepts such as basal and bolus insulin delivery, and carbohydrate counting. Participants using automated insulin delivery (AID) devices, including devices with predictive low glucose suspend (PLGS), in the 3 months prior to screening, will be excluded from participating. 4. A1C 7.0-11.0% by point-of-care taken at screening visit 5. Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment 6. Must have a smartphone that supports the Dexcom app download and participants must be willing to use the app throughout the study 7. Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol 8. Willing to wear the system continuously throughout the study 9. Willing and able to sign the Informed Consent Form (ICF)

Exclusion criteria

1. Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk 2. History of severe hypoglycemia in the past 6 months 3. History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion set failure 4. Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1C. 5. Currently on systemic steroids or intends to receive systemic steroid treatment during study participation, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed. 6. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement 7. Use of non-insulin anti-hyperglycemic medication other than metformin, in the 12 weeks prior to the Baseline Visit. Participants taking metformin should remain on a steady dose during study participation. 8. Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner) 9. Participation in another clinical study using an investigational drug or device within 30-days or 5 half-lives (whichever is longer) prior to screening, or intends to participate in any other study during this study period 10. 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 11. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

Design outcomes

Primary

Measure	Time frame	Description
Percent of Time in Range 70-180 mg/dL	Comparing intervention group with control group during the 13-week study phase	Glucose metric from study continuous glucose monitoring system

Secondary

Measure	Time frame	Description
Change in HbA1c	Baseline compared to end of study visit (Day -30 to Day 90)	Measures device effectiveness
Percent of Time <54 mg/dL (Non-inferiority)	Comparing intervention group with control group at the end of the 13-week study phase	Glucose metric from study continuous glucose monitoring system
Percent of Time >180 mg/dL	Comparing intervention group with control group at the end of the 13-week study phase	Glucose metric from study continuous glucose monitoring system
Percent of Time <70 mg/dL	Comparing intervention group with control group at the end of the 13-week study phase	Glucose metric from study continuous glucose monitoring system
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score	Baseline compared to end of study visit (Day -14 to Day 90)	A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome.
Mean Glucose	Comparing intervention group with control group at the end of the 13-week study phase	Glucose metric from study continuous glucose monitoring system
Change in Diabetes Quality of Life (DQOL)-Brief Total Score	Baseline compared to end of study visit (Day -14 to Day 90)	A questionnaire that assesses the relative burden of an intensive diabetes treatment regimen (15-item scale with 5 choices that range from 1 (Very Dissatisfied/All the Time) to 5 (Very Satisfied/Never)). The total score can range from 1 to 5, with a higher score indicating a better outcome.
Proportion of Participants With T1-DDS MCID After 13 Weeks	Comparing intervention group with control group at the end of the 13-week study phase	Proportion of participants achieving a minimal clinically important difference (MCID) of ≥ 0.19 points (improvement) on the T1-DDS questionnaire total score at 13 weeks compared between treatment groups
Proportion of Participants With DQOL-brief Clinically Meaningful Improvement After 13 Weeks	Comparing intervention group with control group at the end of the 13-week study phase	Proportion of participants achieving a clinically meaningful improvement in the DQOL-brief total score after 13 weeks
Proportion of Participants With HCS Mean Score ≥ 3 After 13 Weeks	Comparing intervention group with control group at the end of the 13-week study phase	Secondary Effectiveness Endpoint of Proportion of Participants with HCS Mean Score ≥ 3 After 13 Weeks OP5
Change in Hypoglycemic Confidence Scale (HCS) Total Score	Baseline compared to end of study visit (Day -14 to Day 90)	A questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome.

Countries

France, United States

Participant flow

Participants by arm

Arm	Count
Intervention Arm Omnipod 5 System with Dexcom G6 continuous glucose monitoring system Omnipod 5 System: Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.	132
Control Arm Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system	62
Total	194

Baseline characteristics

Characteristic	Total	Control Arm	Intervention Arm
Age, Continuous	36 years STANDARD_DEVIATION 14	36 years STANDARD_DEVIATION 13	36 years STANDARD_DEVIATION 14
BMI (kg/m^2)	26.2 (kg/m^2) STANDARD_DEVIATION 4.6	25.4 (kg/m^2) STANDARD_DEVIATION 4.1	26.6 (kg/m^2) STANDARD_DEVIATION 4.8
Daily Insulin Dose	0.62 units/kg STANDARD_DEVIATION 0.19	0.59 units/kg STANDARD_DEVIATION 0.17	0.63 units/kg STANDARD_DEVIATION 0.2
Duration of Insulin Pump Use	9.6 years STANDARD_DEVIATION 7.2	9.8 years STANDARD_DEVIATION 6.8	9.5 years STANDARD_DEVIATION 7.4
HbA1c ≥ 8%	157 Participants	51 Participants	106 Participants
HbA1c at Screening	8.5 Percentage STANDARD_DEVIATION 0.8	8.6 Percentage STANDARD_DEVIATION 0.9	8.5 Percentage STANDARD_DEVIATION 0.8
Previous or Current CGM Use	183 Participants	59 Participants	124 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	3 Participants	2 Participants	1 Participants
Race (NIH/OMB) Black or African American	7 Participants	3 Participants	4 Participants
Race (NIH/OMB) More than one race	4 Participants	2 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants	1 Participants	3 Participants
Race (NIH/OMB) White	99 Participants	29 Participants	70 Participants
Region of Enrollment France	76 participants	24 participants	52 participants
Region of Enrollment United States	118 participants	38 participants	80 participants
Sex: Female, Male Female	116 Participants	38 Participants	78 Participants
Sex: Female, Male Male	78 Participants	24 Participants	54 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 132	0 / 62
other Total, other adverse events	11 / 132	8 / 62
serious Total, serious adverse events	1 / 132	1 / 62

Outcome results

Primary

Percent of Time in Range 70-180 mg/dL

Glucose metric from study continuous glucose monitoring system

Time frame: Comparing intervention group with control group during the 13-week study phase

Population: Subjects are included in the Primary Endpoint Analysis even if data for one period is missing.

Arm	Measure	Group	Value (MEAN)	Dispersion
Intervention Arm	Percent of Time in Range 70-180 mg/dL	Baseline	43.9 Percentage of time	Standard Deviation 14
Intervention Arm	Percent of Time in Range 70-180 mg/dL	13 Weeks	61.2 Percentage of time	Standard Deviation 11.2
Control Arm	Percent of Time in Range 70-180 mg/dL	Baseline	41.3 Percentage of time	Standard Deviation 14.6
Control Arm	Percent of Time in Range 70-180 mg/dL	13 Weeks	43.8 Percentage of time	Standard Deviation 14.5

Secondary

Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score

A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome.

Time frame: Baseline compared to end of study visit (Day -14 to Day 90)

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score	-0.30 score on a scale	Standard Deviation 0.5
Control Arm	Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score	-0.20 score on a scale	Standard Deviation 0.47

Secondary

Change in Diabetes Quality of Life (DQOL)-Brief Total Score

A questionnaire that assesses the relative burden of an intensive diabetes treatment regimen (15-item scale with 5 choices that range from 1 (Very Dissatisfied/All the Time) to 5 (Very Satisfied/Never)). The total score can range from 1 to 5, with a higher score indicating a better outcome.

Time frame: Baseline compared to end of study visit (Day -14 to Day 90)

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	Change in Diabetes Quality of Life (DQOL)-Brief Total Score	0.35 score on a scale	Standard Deviation 0.44
Control Arm	Change in Diabetes Quality of Life (DQOL)-Brief Total Score	-0.02 score on a scale	Standard Deviation 0.45

Secondary

Change in HbA1c

Measures device effectiveness

Time frame: Baseline compared to end of study visit (Day -30 to Day 90)

Population: Subjects are included in the Secondary Endpoint Analysis even if data for one period is missing.

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	Change in HbA1c	-1.24 percentage of HbA1C	Standard Deviation 0.75
Control Arm	Change in HbA1c	-0.68 percentage of HbA1C	Standard Deviation 0.93

Secondary

Change in Hypoglycemic Confidence Scale (HCS) Total Score

A questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome.

Time frame: Baseline compared to end of study visit (Day -14 to Day 90)

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	Change in Hypoglycemic Confidence Scale (HCS) Total Score	0.16 score on a scale	Standard Deviation 0.52
Control Arm	Change in Hypoglycemic Confidence Scale (HCS) Total Score	0.01 score on a scale	Standard Deviation 0.49

Secondary