Insulet : Omnipod® 5 Competitive Clinical Performance

Published: 2026-05-05 12:19:10 ET PODD

Published on 05/05/2026 at 12:19 pm EDT

Omnipod® 5

Competitive Clinical Performance

May, 2026

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The 2026 American Diabetes Association Standards of Care1 make it clear: Automated Insulin Delivery (AID) is no longer optional - it is the preferred approach for insulin delivery in both type 1 and type 2 diabetes

Diabetes is a chronic, progressive disease characterized by either absolute or partial insulin deficiency, leading to various degrees of glycemic variability (hyper and hypoglycemia), impacting overall health and management burden

Omnipod 5 robust evidence has helped shape ADA guidelines

Context is critical when evaluating AID system performance. Omnipod 5 demonstrates competitive clinical results.

No head-to-head trials exist

CGM-measured TIR alone is an incomplete performance metric

Change in glycemic status (e.g., change in HbA1c/TIR) is the standard for assessing a treatment effect in diabetes. Study population differences in baseline glycemic levels impact results achieved.

Omnipod 5 is designed for individualized care across the age spectrum and allows for personalized glucose targets. Optimized settings help achieve tighter glucose control.

Across a comprehensive body of evidence, Omnipod 5 demonstrates strong, competitive clinical performance in a broad and representative population

1. American Diabetes Association Professional Practice Committee. Diabetes Care. 2026.

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Background

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Type 1

The body attacks beta cells resulting in cell death and the need for exogenous insulin, as a form of replacement therapy. Glucose variability (high and low glucose levels) is high.

Type 2

H Y P O G L Y C E M I A

Is characterized by insulin resistance and progressive decline in endogenous insulin production. Residual insulin production attenuates glucose variability (high and low glucose levels). There are multiple treatment options, including insulin treatment.

180

Illustrative Glucose Profile

Hyperglycemia

H Y P E R G L Y C E M I A

Occurs when the body has insufficient insulin, cannot use insulin effectively, or both, leading to glucose building up in the bloodstream instead of being absorbed by cells for energy. Sustained hyperglycemia is linked to complications.

Hypoglycemia

Occurs when the body has insufficient glucose in the blood. Low blood glucose can impair normal bodily and mental functions, quality of life, and in severe cases be life-threatening.

Hypoglycemia in diabetes often results from treatment (sulfonylureas, insulin). Novel approaches to diabetes management, like AID, allow for improved glycemic control without increased hypoglycemia risk, leading to lower glycemic variability

For illustrative purposes

Adapted from Handbook of diabetes, 4th edition. Bilous R, Donnelly R.

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2026 American Diabetes Association (ADA) guidelines endorse Automated Insulin Delivery systems as the preferred insulin delivery method for T1D and insulin-treated T2D1

Only 47% of children and 22% of adults with T1D are using AID. Most people with diabetes are not achieving goals.2

80%

60%

40%

Children

47%

% using AID

80%

60%

40%

Adults

28%

% HbA1c

< 7%

20% 7%

19%

% HbA1c

< 7%

20%

21%

22%

% using

AID

0% 1%

'09-'11 '12-'14 '15-'17 '18-'20 '21-'23

Percent of children using AID

Percent of children at target HbA1C ≤7%

0% 1%

'09-'11 '12-'14 '15-'17 '18-'20 '21-'23

Percent of adults using AID

Percent of adults at target HbA1C ≤7%

1. American Diabetes Association Professional Practice Committee. Diabetes Care. 2026. 2. Adapted from: Fang M, et al. JAMA Netw Open. 2025;8(8):e2526353.

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AID Landscape: Omnipod 5 & Other Manufacturers

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Evaluating AID performance: The importance of context

No head-to-head trials exist with AIDs

Reported differences across AID systems are based on indirect comparisons in different populations, not randomized head-to-head (H2H) studies

In the absence of H2H studies, indirect comparisons can play a role, acknowledging certain limitations

CGM-measured Time in Range (TIR) alone is an incomplete performance metric

AID performance should be assessed using both HbA1c and TIR

Differences in CGM accuracy can over- or under-estimate TIR, complicating cross-study comparisons

Study populations differ and baseline glycemic status matters

Change in glycemic status (e.g., HbA1c reduction) is the standard for assessing treatment effect in diabetes

End-of-study TIR is strongly driven by baseline glycemic control-populations starting with higher TIR (e.g., 75%) will predictably end with higher TIR (e.g., >80%). TIR alone should not be interpreted in isolation.

Use of both, change in HbA1c (and TIR), and end-of-study values, are needed to assess treatment effects

Omnipod 5 is designed for individualized care across the age spectrum and allows for personalized glucose

targets

Preference for higher average glucose levels (with higher glucose targets) can be a choice in individualized care and prioritization of hypoglycemia avoidance

For tighter glycemic control, selection of optimized settings is associated with a TIR of 80%, with hypoglycemia remaining low

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HbA1c

HbA1c (%)

Measures how blood glucose is on average, looking over a 3-month period. It remains the diagnostic standard for assessing population-level health and predicts long-term complication risk.

TIR

Measures how often blood glucose is between 70-180 mg/dL and provides insight into variability.

The measurement relies on CGM's sensor accuracy and provides people with diabetes and health care providers with day-to-day management insights.

There is a high correlation between HbA1C and TIR.

Studies have shown TIR of 65% to 70% is estimated to be a HbA1c of approximately 7.0% which is the ADA target for diabetes management.1-4

At a population level the metrics are

consistent with each other.

Discordant HbA1c and TIR values

could signal CGM inaccuracy issues.

HbA1c and CGM-measured Time in

Range are strongly correlated

0% 20% 40% 60% 80% 100%

Time in Range (70-180) %

Beck RW et al. The relationship between time in range, hyperglycemia metrics and HbA1c. Journal of Diabetes Science and Technology 2019, Vol. 13(4) 614-626

Eliasson B et al. Associations Between HbA1c and Glucose Time in Range Using Continuous Glucose Monitoring in Type 1 Diabetes: Cross-Sectional Population-Based Study. Diabetes Ther. 2024, Vol. 15(6) 1301-1312

Vigersky RA et al. The Relationship of Hemoglobin A1C to Time-in-Range in Patients with Diabetes. Diabetes Technol. Ther. 2019, Vol. 21 (2) 81-85

Burckhardt MA et al. What is the Relationship Between Time in Range, Time in Tight Range, and HbA1c in Youth and Young Adults With Type 1 Diabetes? Results From the German/Austrian/Luxembourgian/Swiss Diabetes Prospective Follow-Up

Registry. J Diabetes Sci Technol. 2024

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Simplera consistently under-read during hyperglycemia

CGM Profile During Hyperglycemia Episode

CGM Profile During Hypoglycemia Episode

350

160

300

140

120

250

100

200

150

100

-60 -30 0 30 60 90

120

-60 -30 0 30 60 90 120

Time from Start of Hyperglycemia [min]

Time from Start of Hypoglycemia [min]

Comparator FL3 DG7 MSP

Simplera overestimated TIR by 8% compared to FSL3 and G7 when all 3 CGMs worn by SAME patient

"Simplera showed better glucose control… compared with the other two. This could lead to misleading conclusions and potentially misguided therapy advice."

- Dr. Guido Freckmann

Glucose Level [mg/dL]

FreeStyle Libre 3

Dexcom G7 Simplera

Freckmann G et al. Diabetes Care. 2025;48(00):1-5. Twenty-three adults with T1D wore all three sensors in parallel for 15 days.

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Baseline imbalance can distort headline comparisons across studies

Populations with better glycemic control at baseline (lower HbA1c, or higher TIR, e.g., 75%), will predictably report higher absolute results (e.g., TIR 80% at end of study), even with similar or smaller treatment effects (change from baseline)

Omnipod 5:

"The clearest predictor of improved TIR (and HbA1c) was prior low TIR (high HbA1c) and this is in line with prior AID studies focused on individuals with high baseline HbA1c."

- Stimson, et al.3

Higher TIR

with AID

Lower TIR with AID

Lower TIR

at Baseline

Higher TIR

at Baseline

100

Final TIR with any AID System

0 10 20 30 40 50 60 70 80 90 100

TIR at Baseline

Strong relationship between baseline TIR and final TIR for all AID systems1,2,3

Control-IQ:

"Higher baseline TIR is the strongest predictor of TIR on CLC in children with T1D."

- Schoelwer, et al.1

Minimed 780G:

"There was a strong correlation between baseline TIR and TIR post-AHCL indicating that those with higher TIR at baseline tended to have higher TIR post-AHCL."

- Castañeda, et al.2

1. Schoelwer et al. Predictors of Time-in-Range (70-180 mg/dL) Achieved Using a Closed-Loop Control System. DTT. 2021;23(7):475-81. 2. Castañeda et al. Predictors of time in target glucose range in real-world users of the MiniMed 780G system.

Diabetes Obes Metab. 2022;24(11):2212-21. 3. Stimson, et al. Impact of Omnipod 5 automated insulin delivery on continuous glucose monitoring metrics and predictors of improvement in time in range. Diabet Med. 2025;42:e70137.

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Omnipod 5 achieved same HbA1c as other AIDs and similar TIR vs. Control-IQ. There is discrepant TIR & HbA1c results between 780G and other AIDs.

It is lower HbA1c that has been proven to reduce risk of long-term complications1 and thus what is ultimately most

important to compare.

Henry 20232 Piona 20243 Folk 20254 Gera 20255 Khan 20266 Pavlou 20267

Study Population

Study Arms

Final TIR, %

Final HbA1c (change), %

T1D adults & adolescents (N=231)

780G CIQ

(n=167) (n=64)

74† 65

7.1 7.0

(-0.8) (-0.6)

T1D

children/youth (N=613)

780G CIQ

(n=329) (n=284)

75† 68

6.9 6.7

T1D adults (N=176)

T1D youth (N=428)

T1D adults (N=213)

T1D adults (N=129)

OP5

(n=52)

CIQ

(n=67)

OP5

(n=214)

CIQ

(n=214)

OP5

(n=94)

CIQ 780G

(n=81) (n=38)

OP5

(n=81)

780G

(n=48)

72†

6.8

(-0.55)

7.0

(-0.6)

7.6

(-0.9)

7.6

(-0.8)

- -

†TIR inconsistent with HbA1c

1. Diabetes Control and Complications Trial Research Group, et al. N Engl J Med. 1993;329(14):977 -86. 2. Henry Z, et al. Diabetes Obes Metab. 2024;26(2):557-66. 3. Piona C, et al. Diabetes Obes Metab. 2024;26(10):4767-71. 4. Folk S, et al. J Diabetes Sci Technol. 2025;19(5):1374-84. 5. Gera S, et al. J Clin Endocrinol Metab. 2025;110(10):e3472-e81. 6. Khan MS, et al. Diabet Med. 2026;43(5):e70251. 7. Pavlou P, et al. Diabetes Obes Metab. 2026;28(4):3424-8.

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Omnipod 51,*

Control IQ 2,†

780G 3,‡

iLet 4,§

1.1%

1.4%

2.3%

1.9%

74%

71%

75%

69%

Baseline → Final

HbA1c

7.2% → 6.8%

→ 7.1%

→ 7.0%

→ 7.1%

-20%

20% 0% 20% 40% 60% 80% 100%

% of time

TBR Baseline TIR AID TIR

Results from pivotal trials.

*14-70 years old. †14-71 years old. ‡14-75 years old. §18-79 years old.

Data shown as mean (TIR, A1C) or median (TBR). TBR outcomes with 780G are reported as mean. AID outcomes assessed over 6 mont hs (Control-IQ) or 3 months (all others).

1. Brown SA, et al. Diabetes Care. 2021;44(7):1630-1640. 2. Brown SA, et al. N Engl J Med. 2019;381(18):1707-1717. 3. Carlson AL, et al. Diabetes Technol Ther. 2022;24(3):178-189. 4. Kruger D, et al. Diabetes Technol Ther. 2022;24(10):697-711.

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Both studies were in populations with high baseline HbA1c

Final HbA1c achieved by adults with T1D is

identical in both studies

HbA1c

Omnipod 51

RADIANT trial

Medtronic 780G2

ADAPT trial

7.3%

Final TIR of 780G is inconsistent with HbA1c

TIR

Discrepant final TIR vs HbA1c with 780G

Omnipod 51

RADIANT trial

Medtronic 780G2

ADAPT trial

65%

71%

1. Wilmot E, et al. Lancet D&E. 2026;14(4):305-16. 2. Choudhary P, et al. Lancet Diabetes Endocrinology. 2022; 10: 720-31.

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Insulet's trial enrolled a more racially diverse cohort, reflective of the T2D population, and delivered

the largest TIR improvement-a differentiation validated by a recent type 2 diabetes meta-analysis4

Omnipod 51

Medtronic 780G2

Control-IQ+3

Adults (18 yr+)

HbA1c

-0.8%

-0.7%

-0.9%

8.2% / 7.4%

7.9% / 7.2%

8.2% / 7.3%

TIR

+20%

+7%

+16%

45% / 66%

72% / 80%

48% / 64%

TDI change in

-23 U

+14 U

-8 U

units

80 / 57

77 / 92

95 / 87

Weight

+0.8

+1.0

+2.6

change, kg

99.7 / 100.4

105.8 / 107.3

100.5 / 103.1

Minority Race

~50%

~20%

~40%

Change in Time in Range

Starting

Change

TIR

KEY

Ending TIR

40% 50% 60% 70% 80%

45%

20%

66%

Omnipod 5

Pasquel, 2025

48%

16%

64%

Control-IQ+

Kudva, 2025

High TIR at baseline, correlates with high TIR at end of study, minimal improvement in TIR

72% 7% 80%

Discrepant TIR

to HbA1c

780G

Bhargava, 2025

Except for race, data are change, followed by baseline / end of study values with the HCL study arm. All results are mean.

Discrepancies in change are due to rounding.

1. Pasquel. JAMA Network Open. 2025; 8(2):e2459348. Omnipod 5 pivotal ages 18-75 yrs. 2. Bhargava. Diab Tech & Ther. 2025;27(5):366-75. 780G Pivotal trial ages 18-80 yrs. 3. Kudva. N Engl J Med. 2025 May 8;392(18):1801-1812.

Control-IQ pivotal trial ages ≥ 18 yrs. 4. Hespanhol LC, et al. Diabetes Care. 2026. Online ahead of print.

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Change

Omnipod 5

39% +13% 52%

Wolf 2025

40% 50% 60% 70% 80%

Starting

TIR

KEY

Ending

TIR

Wolf RM, et al. DTT. 2025;27(6):469-78.

Messer LH, et al. DTT. 2021;23(12):837-43.

Abraham MB, et al. Diabetes Care. 2025;48(1):67-75.

Stimson RH, et al. Diabet Med. 2025;42(3):e15465.

De Meulemeester J, et al. Diabetologia. 2025;68(5):948-60.

Lepore G, et al. DTT. 2024;26(1):49-58.

Brown SA, et al. N Engl J Med. 2019;381(18):1707-17.

Brown SA, et al. Diabetes Care. 2021;44(7):1630-40.

Carlson AL, et al. DTT. 2022;24(3):178-89.

37% +16%

53%

Control-IQ

Messer 2021

37% +15% 52%

780G

Abraham 2024

Omnipod 5

Stimson 2025

Control-IQ

De Meulemeester 2025

780G

Lepore 2024

Omnipod 5

Brown 2021

Control-IQ

Brown 2019

780G

Carlson 2022

55% +15% 70%

59% +12% 71%

58% +12% 70%

+9%

Studies with low TIR at entry

(3 independent studies of T1D youth cohorts with high baseline HbA1c in US/Australia)

Studies with mid-range TIR at entry

(3 independent clinic-based studies of T1D adults in UK/EU)

65%

74%

Studies with high TIR at entry have the highest final TIR for any AIDs

(3 pivotal trials of AID in T1D

adults)

61%

71% +10%

69% 75% +6%

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KEY

Starting

TIR

Ending

Change

TIR

A recent meta-analysis focused on end of study TIR, across

a select group of studies, implying a higher TIR for 780G

40 45 50 55 60 65 70 75 80 85

When you assess TIR change from baseline in those same

studies, a comparable effect is observed across systems

40 45 50 55 60 65 70 75 80 85

Matejko 2024 Polish Users Thrasher 2024 All Ages Smaniotto 2025 Older Users

Arrieta 2022 >15yrs Grassi 2023 Prior 670G LATAM Grassi 2023 Prior 640G LATAM Da Silva 2022 Pre-AHCL Dekker 2024 670G

Passanisi 2024 Children and Adolescents

Castaneda 2024 >15 Breton 2021 All Ages Arrieta 2022 <15yrs

Matejko 2024 EU minus Polish Users

Forlenza 2024 Adults Dekker 2024 640G Smaniotto 2025 16-55 yrs

Passanisi 2024 Children and Adolescents BL A1c >8

Halim 2024 All Ages Australia Castaneda 2024 <15

De Meulemeester 2025 Adults Belgium

Lepore 2024 Adults Kovatchev 2022 All Ages

Forlenza 2024 Children and Adolescents

Dekker 2024 780G Manual

Gera 2025 Youth

Gera 2025 Youth Meighan 2024 Youth, self-start Meighan 2024 Youth, CDCES training

Pöhlmann J, DOM. 2026 Jan;28 Suppl 1(Suppl 1):13-34. Arrieta A, et al. DOM. 2022;24(7):1370-9. Breton MD, et al. DTT. 2021;23(9):601-8. Castaneda J, et al. Diabetes Care. 2024;47(5):790-7. Da Silva J, et al. DTT. 2022;24(2):113-9. De Meulemeester J, et al. Diabetologia. 2025;68(5):948-60. Dekker P, et al. JDST. 2024:19322968241290259. Forlenza GP, et al. DTT. 2024;26(8):514-25. Gera S, et al. JCEM. 2025;110(10):e3472-e81. Grassi B, et al. DOM. 2023;25(6):1688-97. Halim B, et al. DTT. 2024;26(3):190-7. Kovatchev BP, et al. Diabetes Care. 2022;45(11):2636-43. Lepore G, et al. DTT. 2024;26(1):49-58. Matejko B, et al. DRCP.

2024;216:111832. Meighan S, et al. DTT. 2024;26(10):773-9. Passanisi S, et al. Diabetes Care. 2024;47(6):1084-91. Smaniotto V, et al. DOM. 2025;27(4):2242-50. Thrasher JR, et al. DTT. 2024;26(S3):24-31.

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Change in % Time in Range across 19 Omnipod studies

30 50 70

Carletti 2026 ATTD All ages Stimson 2024 Adults Libre Cohort

Busi 2026 ATTD Youth Tinti 2025 Adolescents

Starting

TIR

KEY

Change

Ending

TIR

Ng 2025 Children Khan 2025 Adults Folk 2024 Adults Aslam 2024 Adults

Angelino 2025 Adults Italy Stimson 2025 Adults Chapman 2025 All Ages

Berget 2025 Youth

Marks 2023 Youth Granados 2025 Pediatric and Young Adult

Stimson 2024 Adults Pavlou 2026 Adults

Wolf 2025 2-21yrs, White Cohort Li 2025 Young Children

Kaan 2026 ATTD All Ages Psychosocial Barriers

Wolf 2025 2-21yrs, Black Cohort

Average 13% TIR improvement in independent clinic studies with Omnipod 5 in US, UK, and Italy

Omnipod 5 delivered clinically meaningful TIR improvement in all patients, especially those with poor baseline control who are often overlooked as candidates for AID

Angelino S, et al. Front Endocrinol. 2025;16:1717249. Aslam A, et al. DOM. 2024;26(8):3462-5. Berget C, et al. DOM. 2025;27(9):4942-9. Busi PS, et al. DTT. 2026;28(3_suppl):174S. Carletti L, et al. DTT. 2026;28(3_suppl):337S. Chapman A, et al. Diabet Med. 2025;42(4):e70000. Folk S, et al. JDST. 2025;19(5):1374-84. Granados A, et al. JPEM. 2025;38(4):340-4. Kaan D, et al. DTT. 2026;28(3_suppl):164-5S. Khan MS, et al. Diabet Med. 2026;43(5):e70251. Li M, et al. Diabetes Spectr. 2025;38(4):423 -30. Marks BE, et al. DTT. 2023;25(11):782-9. Ng SM, et al. DTT. 2025;27(7):562-6. Pavlou P, et al. DOM.

2026;28(4):3424-8. Stimson RH, et al. Diabet Med. 2025;42(3):e15465. Stimson RH, et al. Diabet Med. 2024;41(12):e15453. Stimson RH, et al. Diabet Med. 2025;42(11):e70137. Tinti D, et al. DOM.

2025;27(8):4567-70. Wolf RM, et al. DTT. 2025;27(6):469-78. INS-OHS-04-2026-00416 V1.0

Omnipod 5 was designed to allow for users to

customize their therapy to their goals.

57-82% of pediatric users have multiple targets

38-45% of adult users have multiple targets

Omnipod 5 has the broadest range of target glucose options to enable user choice

Preference for higher average glucose levels (with higher glucose targets) can be a choice in individualized care and prioritization of hypoglycemia avoidance

It is important to remember the target glucose settings in interpreting clinical results

With use of Optimized Settings, Omnipod 5 Users

achieve 80% TIR

In real-world use, Omnipod 5 users are selecting different glycemic targets according to individual goals (e.g., 2-5 years of age population benefits from more conservative targets)

100

% of people using each target

Average Target

(mg/dL)

150

140

130

120

110

2-5

N=2166

6-12

N=11681

13-17

N=8315

18-25

N=8396

26-49

N=23478

50-64

N=11376

≥65

N=4490

Age Group (y)

Omnipod 5 target use data from Forlenza GP, et al. Diabetes Technol Ther. 2024;26(8):514-25.

Optimized settings of 110 mg/dL Target Glucose, ISF x TDI ≤ 1500, I:C Ratio x TDI ≤ 350

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$207K

Estimated payer diabetes-related medical cost savings per 1,000 T2D user years of Omnipod 5 vs. tubed systems

Absolute difference in predicted diabetes-related event rates per 1,000 T2D

user years with Omnipod 5 vs tubed systems

Emergency department visits

Inpatient admissions

-8.98*

Average cost per event

-21.4*

$360

$22,143

*p<0.05.

US claims data: 110,061 Omnipod 5; 113,454 tubed systems

Komodo (US) claims data analysis. weighted estimates based on individuals aged ≥2 years initiating Omnipod 5 or another tubed system from 1 August 2022 - 31 May 2024 with ≥180 days pre-initiation observation, followed until (1) health insurance enrolment ends, (2) filled a prescription for a different pump type, or (3) reached end of study period: 31 May 2025. All analyses adjusted for demographic and clinical covariates and used stabilized inverse probability weighting based on propensity scores, with models incorporating conservative heteroskedastic-robust standard errors. For T1D, age was modelled categorically with groups. For T2D, age was modelled as continuous. Average cost per event are based on insurer paid amount among commercial claims. Data on File. RF-042026-00021

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Disclaimer

Insulet Corporation published this content on May 05, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 05, 2026 at 16:18 UTC.