OP5-005 Using Omnipod 5 in Adults With Type 2

Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05815342

Acronym

SECURE-T2D

Enrollment

343

Registered

2023-04-18

Start date

2023-04-11

Completion date

2024-03-01

Last updated

2025-09-29

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

Conditions

Type2 Diabetes

Keywords

T2D, Omnipod, Automated Insulin Delivery

Brief summary

This is a single arm, multi-center, prospective study that will evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.

Detailed description

This outpatient study consists of 2 phases. Phase 1 is a 14-day period to collect baseline glucose and insulin data. Participants will manage their diabetes as an outpatient per their usual routine. During this time participants will wear a blinded continuous glucose monitor to collect baseline glycemic information. Phase 2 is a 13 week treatment period during which participants will use the Omnipod 5 System consisting of the Omnipod 5 pod, Omnipod 5 app as well as a Dexcom G6 continuous glucose monitor. Participants will do in-clinic or virtual visits at least monthly for a total of 8 visits. During the treatment period all participants will undergo supervised exercise and meal challenges.

Interventions

DEVICEOmnipod 5 Automated Glucose Control System

The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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 current insulin regimen for at least 3 months prior to screening (i.e. Basal-bolus, basal only or pre-mix) 3. Basal bolus (long-acting insulin and rapid acting analog) or pre-mix users with A1C \<12.0% OR basal users on long or intermediate acting insulin only with A1C \> 7.0% and \< 12.0% 4. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog 5. Participant agrees to provide their own insulin for the duration of the study 6. Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator 7. Stable doses of weight loss medications over the preceding 4 weeks and throughout the study that may affect glycemic control directly and/or indirectly, except for a dose reduction or discontinuation, 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 participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol 11. Able to read and understand English or Spanish 12. Willing and able to sign the Informed Consent Form (ICF) 13. If female of childbearing potential, willing and able to have pregnancy testing

Exclusion criteria

1. Use of an AID pump in automated mode within 3 months prior to screening 2. Any medical condition which in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia) 3. 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 12 months prior to screening 4. Any planned surgery during the study which could be considered major in the opinion of the investigator 5. History of more than 1 severe hypoglycemic event in the 6 months prior to screening 6. History of more than 1 episode of diabetic ketoacidosis (DKA) or Hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening; unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis 7. 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 8. Plans to receive blood transfusion over the course of the study 9. Has taken oral or injectable steroids within 8 weeks prior to screening or plans to take oral or injectable steroids during the study 10. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement 11. Pregnant or lactating, planning to become pregnant during the study, 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); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal) 12. Participation in another clinical study using an investigational drug or device other than the Omnipod 5 in the 30 days prior to screening or intends to participate during the study period 13. 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 14. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned

Design outcomes

Primary

Measure	Time frame	Description
Change in HbA1c	Comparing the change in HbA1c during the 13 weeks study phase	The change in HbA1c at 13 weeks from baseline

Secondary

Measure	Time frame	Description
Percent of Time ≥ 300 mg/dL	Measured during 13 weeks study phase	Glucose metric from CGM
Percent of Time > 250 mg/dL	Measured during 13 weeks study phase	Glucose metric from CGM
Percent of Time >180 mg/dL	Measured during 13 weeks study phase	Glucose metric from CGM
Mean Glucose	Measuring mean glucose during the 13 weeks study phase	Glucose metric from study provided continuous glucose monitor (CGM)
Percentage of Time in Range 70-180 mg/dL	Measured during 13 weeks study phase	Glucose metric from CGM
Percent of Time < 70 mg/dL [Non-inferiority; Non-inferiority Limit 2.0%]	Measured during 13 weeks study phase	Glucose metric from CGM
Percent of Time < 54 mg/dL [Non-inferiority; Non-inferiority Limit 0.5%]	Measured during 13 weeks study phase	Glucose metric from CGM
Change From Baseline in T2-DDAS Total Score	Baseline compared to end of week 13 visit	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.
Percent of Time in Range 70-140 mg/dL	Measured during 13 weeks study phase	Glucose metric from study CGM
Change From Baseline in Pittsburgh Sleep Quality Index Total Score	Baseline compared to end of week 13 visit	Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items. Minimum Score = 0 (better); Maximum Score = 21 (worse). Lower scores indicate better outcomes (eg, less distress related to diabetes, better sleep quality).
% Meeting MCID for Pittsburgh Sleep Quality Index	Baseline compared to end of week 13 visit	Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items.
Change From Baseline in HCS Total Score	Baseline compared to end week 13 visit	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.
% Meeting MCID for HCS	Baseline compared to end week 13 visit	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.
Percentage of Time <70 mg/dL (Superiority)	Measured during 13 weeks study phase	Glucose metric from CGM
Percentage of Time <54 mg/dL (Superiority)	Measured during 13 weeks study phase	Glucose metric from CGM
Coefficient of Variation	Measured during 13 weeks study phase and compared to standard therapy	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.
Percentage Meeting MCID for T2-DDAS	Baseline compared to end week 13 visit	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Treatment All subjects wearing the Omnipod 5 Automated Glucose Monitoring System Omnipod 5 Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery	305
Total	305

Withdrawals & dropouts

Period	Reason	FG000
Baseline, Standard Therapy (2 Weeks)	Ineligible	4
Baseline, Standard Therapy (2 Weeks)	Lost to Follow-up	2
Baseline, Standard Therapy (2 Weeks)	Withdrawal by Subject	9
Treatment Phase (13 Weeks)	Lost to Follow-up	2
Treatment Phase (13 Weeks)	Withdrawal by Subject	14

Baseline characteristics

Characteristic	Treatment
Age, Continuous	57 years STANDARD_DEVIATION 11
BMI	35 kg/m^2 STANDARD_DEVIATION 8
HbA1C	8.2 Percentage of HbA1C STANDARD_DEVIATION 1.3
Race/Ethnicity, Customized ≥1 Race, not Hispanic or Latino	3 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native, not Hispanic or Latino	2 Participants
Race/Ethnicity, Customized Asian or Pacific Islander, not Hispanic or Latino	7 Participants
Race/Ethnicity, Customized Black, not Hispanic or Latino	72 Participants
Race/Ethnicity, Customized Hispanic or Latino	66 Participants
Race/Ethnicity, Customized Unknown	2 Participants
Race/Ethnicity, Customized White, not Hispanic or Latino	153 Participants
Sex: Female, Male Female	175 Participants
Sex: Female, Male Male	130 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 320	0 / 305
other Total, other adverse events	3 / 320	43 / 305
serious Total, serious adverse events	1 / 320	13 / 305

Outcome results

Primary

Change in HbA1c

The change in HbA1c at 13 weeks from baseline

Time frame: Comparing the change in HbA1c during the 13 weeks study phase

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change in HbA1c	Baseline or Standard Therapy (2 weeks)	8.2 Percentage of HbA1C	Standard Deviation 1.3
Treatment	Change in HbA1c	End of treatment or treatment phase (13 weeks)	7.4 Percentage of HbA1C	Standard Deviation 0.9

Secondary

Change From Baseline in HCS Total Score

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 week 13 visit

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in HCS Total Score	Baseline of Standard Therapy (2 weeks)	3.2 score on a scale	Standard Deviation 0.6
Treatment	Change From Baseline in HCS Total Score	End of treatment or treatment phase (13 weeks)	3.3 score on a scale	Standard Deviation 0.6

Secondary

Change From Baseline in Pittsburgh Sleep Quality Index Total Score

Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items. Minimum Score = 0 (better); Maximum Score = 21 (worse). Lower scores indicate better outcomes (eg, less distress related to diabetes, better sleep quality).

Time frame: Baseline compared to end of week 13 visit

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in Pittsburgh Sleep Quality Index Total Score	Baseline or ST (2 weeks)	7.3 score on a scale	Standard Deviation 4
Treatment	Change From Baseline in Pittsburgh Sleep Quality Index Total Score	End of treatment or treatment phase (13 weeks)	7.0 score on a scale	Standard Deviation 4.1

Secondary

Change From Baseline in T2-DDAS 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 week 13 visit

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Change From Baseline in T2-DDAS Total Score	Baseline or Standard Therapy (2 weeks)	2.5 Score	Standard Deviation 1
Treatment	Change From Baseline in T2-DDAS Total Score	End of treatment or treatment phase (13 weeks)	2.2 Score	Standard Deviation 0.9

Secondary

Coefficient of Variation

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.

Time frame: Measured during 13 weeks study phase and compared to standard therapy

Population: Based on the pre-specified criteria (CGM analyses will include all participants with ≥168 hours of CGM data during each of the Standard therapy period and the 13-week treatment period.), N=299 for the glycemic metrics.

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Coefficient of Variation	Baseline or Standard Therapy (2 weeks)	27.8 Percent coefficient of variation	Standard Deviation 6.3
Treatment	Coefficient of Variation	End of treatment or treatment phase (13 weeks)	27.1 Percent coefficient of variation	Standard Deviation 5.1

Secondary

Mean Glucose

Glucose metric from study provided continuous glucose monitor (CGM)

Time frame: Measuring mean glucose during the 13 weeks study phase

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment	Mean Glucose	Baseline or Standard Therapy (2 weeks)	202 mg/dL	Standard Deviation 50
Treatment	Mean Glucose	End of treatment or treatment phase (13 weeks)	170 mg/dL	Standard Deviation 24

Secondary

% Meeting MCID for HCS

Time frame: Baseline compared to end week 13 visit

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

Arm	Measure	Group	Value (NUMBER)
Treatment	% Meeting MCID for HCS	Baseline or Standard Therpey (2 weeks)	32 Percentage
Treatment	% Meeting MCID for HCS	End of treatment or treatment phase (13 weeks)	0.2 Percentage

Secondary

% Meeting MCID for Pittsburgh Sleep Quality Index

Change from baseline in PSQI total score which assesses sleep quality over a one month interval. The survey includes 10 self-rated items.

Time frame: Baseline compared to end of week 13 visit

Population: The number of participants with available data ranged from 294 to 305 across outcomes.

Arm	Measure	Group	Value (NUMBER)
Treatment	% Meeting MCID for Pittsburgh Sleep Quality Index	Baseline or ST (2 weeks)	63 Percentage
Treatment	% Meeting MCID for Pittsburgh Sleep Quality Index	End of treatment or treatment phase (13 weeks)	59 Percentage

Secondary

Percentage Meeting MCID for T2-DDAS

Time frame: Baseline compared to end week 13 visit

Arm	Measure	Group	Value (NUMBER)
Treatment	Percentage Meeting MCID for T2-DDAS	Baseline or Standard Therapy (2 weeks)	66 Percentage
Treatment	Percentage Meeting MCID for T2-DDAS	End of treatment or treatment phase (13 weeks)	55 Percentage

Secondary