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Abstract

Background:

Hybrid closed-loop (HCL) systems combine continuous glucose monitoring (CGM) with insulin pumps to automate insulin delivery through specific algorithms and user input. This real-world study aimed to evaluate the effectiveness of the Omnipod5 HCL system on HbA1c, time-in-range (TIR), hypoglycemia frequency, and sensor glucose variability over 3 and 6 months in children and young people with type 1 diabetes at two National Health Service (NHS)-funded pediatric diabetes centers in North West England.

Methods:

Children younger than 18 years in two teaching hospital-based diabetes centers were started on Omnipod5 between August 2023 and January 2024. Sensor glucose metrics and HbA1c were collected within 3 months before Omnipod5 initiation and compared at 3 and 6 months postinitiation. Metrics included % TIR (sensor glucose 70–180 mg/dL), % time above range (TAR) (sensor glucose >180 mg/dL and >250 mg/dL), and % time below range (TBR) (sensor glucose <70 mg/dL mmol/L and <54 mg/dL), with variability assessed by coefficient of variation (CV) and standard deviation (SD).

Results:

A total of 144 children were included, with 46% males and a mean age of 7.1 years (SD 4.3). The cohort was predominantly White (80%), with diabetes duration averaging 4.4 years (SD 3.9). Before Omnipod5, 54% used multiple daily injections, 41% a nonintegrated pump, and 5% another HCL system. At 3 and 6 months postinitiation, there were significant improvements in HbA1c from 7.7% (60.2 mmol/mol) to 7.1% (54.4 mmol/mol) at 3 months and 7.2% (55.2 mmol/mol) at 6 months. TIR improved from 53.3% at baseline to 67.4% at 3 months and 68.8% at 6 months), and reductions in TAR, TBR, and CV were also observed.

Conclusions:

These findings highlight the Omnipod5 system’s safety and effectiveness in improving glycemic control for children and young people (CYP) with type 1 diabetes in a real-world NHS setting. Further research is needed to explore the long-term benefits and cost-effectiveness of this tubeless HCL system in routine clinical care.

Introduction

Type 1 diabetes is a chronic condition affecting 9.5% of the world’s population, and its prevalence is increasing.¹ Improving glycemic management and reducing HbA1c have been shown to reduce the risk of long-term complications of type 1 diabetes mellitus (T1DM), including diabetic retinopathy and blindness, heart disease, stroke, kidney failure, peripheral neuropathy, and limb amputation. Children and young people with T1DM and their caregivers are required to manage their condition through balancing insulin doses with diet and activity. This can be particularly challenging as children grow and experience changes to their lifestyles and insulin requirements.² The technology to aid the treatment of T1DM has been advancing at a rapid pace, and many children can now access continuous glucose monitoring (CGM) and insulin pumps to help them manage their condition. A hybrid closed-loop (HCL) system is a sophisticated diabetes management tool that uses real-time CGM to automate insulin delivery. This cutting-edge technology combines elements of traditional insulin pumps and CGM to offer a more integrated and adaptive approach to managing diabetes.³ For children and adults with T1DM, HCL systems have shown promise in enhancing overall glycemic control, reducing fluctuations in blood glucose levels that can cause hypoglycemia, and alleviating the fear of hypoglycemic episodes.^4,5

HCL systems have very recently been made freely accessible to all children and young people with T1DM in the United Kingdom, following the publication of the updated NICE Technology Appraisal.⁶ There are multiple tethered insulin pumps and HCL systems available on the UK National Health Service (NHS), all of which have shown good outcomes for improving glycemic control and quality of life for children with T1DM. But up until recently, there has not been a tubeless pump option offering the benefit of automatic insulin delivery. In June 2023, Insulet Corp released the Omnipod5 HCL system in the United Kingdom, which worked in conjunction with a Dexcom G6 sensor, and since June 2024, it has been compatible with the Libre 2 Plus sensor. This real-world study shares the HbA1c and sensor glucose outcomes at 3 and 6 months for two pediatric diabetes children centers in implementing the Omnipod5 HCL system under the NHS universal coverage within a real-world setting.

Methods

This study was a real-world observational service evaluation conducted at two diabetes centers (teaching hospital-based clinics) in the North of England. We included all individuals (age younger than 18 years) from our pediatric clinic caseload who commenced onto the Omnipod5 HCL system between August 2023 and January 2024. Sensor glucose metrics and HbA1c were obtained 3 months before the start of Omnipod5 HCL and then compared at 3 and 6 months postcommencement of Omnipod5. Sensor glucose metrics were reported as percentage time in range (%TIR) (defined as sensor glucose level between 70 and 180 mg/dL [3.9 and 10.0 mmol/L]), percentage time above range (TAR) (defined as sensor glucose level >180 mg/dL [10.0 mmol/L] and 250 mg/dL [13.9 mmol/L]), percentage time below range (TBR) (defined as sensor glucose level <70 mg/dL [3.9 mmol/L] and 54 mg/dL [3.0 mmol/L]), and glucose variability defined by percentage coefficient of variation (CV) and standard deviation (SD) from average glucose profiles. Various platforms were used to obtain the sensor metrics, including Dexcom Clarity, LibreView, Glooko, and Tidepool, which were reviewed within 3 months before being commenced on the Omnipod5 HCL, and then again at 3 months and 6 months post-commencement. Ethnicity information was recorded through the NHS classification system.

Statistical analysis

The analysis of data was conducted using Statistical Package for Social Sciences 21.0 (version 23; SPSS Inc., Chicago, IL, USA). To ensure the reliability of continuous outcomes, distributions were scrutinized. Results were presented as the mean and standard deviation (SD) for continuous parametric outcomes and the median and interquartile range for nonparametric outcomes. For continuous parametric outcomes, Student’s t-test was used, while the Mann–Whitney Wilcoxon test was used for nonparametric outcomes. Demographic comparisons between the two centers were assessed. Only data from patients who completed 3 and 6 months were analyzed. Bayesian one-way repeated-measure analysis of variance was utilized to compare values at the start and at the 3 and 6 months of the study. A P value ≤0.05 was considered statistically significant.

Results

A total of 144 children and young people with T1DM were included from two centers comprising 46% males and 54% females. The mean age on commencement of Omnipod5 HCL was 7.1 years (SD 4.3, range 1.1–17). The majority (80%) were of White ethnicity, 5% Black ethnicity, 5% Asian, 3% mixed ethnicity, and 2% other. The overall mean duration of diabetes was 4.4 years (SD 3.9), ranging from 0.7 to 13.9 years. There were 54% who were on multiple daily insulin regimens, 41% on a nonintegrated insulin pump, and 5% were from another HCL system before commencing Omnipod5. Demographics between the two children diabetes centers were not significantly different. There were 49 from the Southport and Ormskirk Hospital, Mersey West Lancashire Teaching Hospitals NHS Trust, 41% males, mean duration of T1D was 4.5 years ± 3.8 SD, and mean age of diagnosis was 7.4 years ± 4.4 SD. In the Sheffield Children’s Hospital NHS, there were 95, including 49% males, mean duration of T1D was 4.4 years ± 3.9 SD, and mean age of diagnosis was 6.4 years ± 4.1 SD.

The results in Table 1 show significant improvements in HbA1c, TIR, TAR, TBR, as well as CV metrics at 3 and 6 months post-commencement on the Omnipod5 HCL system. HbA1c improved from 7.7% (60.2 mmol/mol) to 7.1% (54.4 mmol/mol) at 3 months, which was sustained at 6 months with an HbA1c of 7.2% (55.2 mmol/mol). The percentage time of glucose spent as TIR also showed a sustained improvement from 53.3% at baseline to 67.4% at 3 months and 68.8% at 6 months post-commencement of Omnipod5. Reductions in TAR, TBR, and CV were also observed except TBR <54 mg/dL (3.0 mmol/L), which was low at baseline and was not significantly changed by the HCL system.

Table 1.

Comparison of Variables Pre-Omnipod5 Versus Post-Omnipod5 Hybrid Closed-Loop Commencement at 3 and 6 Months

Variables	Before OP5	3 Months after OP5	6 Months After OP5	Difference (95% confidence interval) from baseline to 3 months	P value	Difference (95% confidence interval) from baseline to 6 months	P value
HbA1c % (mmol/mol)	7.7 ± 3.1 (60.2 ± 10.8)	7.1 ± 3.1 (54.4 ± 9.9)	7.2 ± 2.8 (55.2 ± 6.9)	0.6 (0.5–1.3)	P < 0.001	0.5 (0.4 to 1.2)	P < 0.001^*
% TIR 70–180 mg/dL (3.9 and 10.0 mmol/L)	53.3 ± 16.3	67.4 ± 9.9	68.8 ± 10.6	−14.1 (−16.8 to −11.3)	P < 0.001	−15.5 (−19.0.5 to −12.0)	P < 0.001^*
% Hypoglycemia	3.5 ± 1.2	2.4 ± 1.1	2.7 ± 1.5	1.1 (0.5 to 01.6)	P = 0.005	0.8 (0.1 to 1.6)	P = 0.005^*
% TAR >180 mg/dL (>10 mmol/L)	33.0 ± 13.3	25.3 ± 10.1	24.5 ± 10.8	7.7 (5.3 to 9.7)	P < 0.001	8.5 (6.2 to 10.9)	P < 0.001^*
% TAR >250 mg/dL (>13.9 mmol/L)	18.5 ± 14.4	11.0 ± 7.8	10.0 ± 7.9	7.5 (5.6 to 10.2)	P < 0.001	8.5 (5.2 to 11.6)	P < 0.001^*
% TBR <70 mg/dL (<3.9 mmol/L)	3.4 ± 1.6	2.4 ± 2.3	2.5 ± 2.4	1.0 (−0.06 to 1.5)	P = 0.07	0.9 (0.06 to 1.6)	P = 0.03^*
% TBR <54 mg/dL (<3.0 mmol/L)	1.0 ± 0.8	0.5 ± 0.9	0.7 ± 1.2	0.5 (−0.1 to 0.9)	P = 0.06	0.3 (−0.1 to 0.8)	P = 0.15
CV (%)	39.3 ± 7.2	38.9 ± 6.2	38.2 ± 6.0	0.4 (−1.0 to 1.6)	P = 0.64	1.1 (−0.9 to 2.1)	P = 0.44
SD	3.9 ± 0.9	3.5 ± 0.7	3.5 ± 0.9	0.4 (0.2 to 0.6)	P < 0.001	0.4 (0.1 to 0.7)	P = 0.005^*

Data are shown as mean ± standard deviation.

A P value ≤0.05 was considered statistically significant.

CV, coefficient of variation; HCL, hybrid closed loop; OP5, Omnipod5; SD, standard deviation; TAR, time above range; TBR, time below range; TIR, time in range.

Discussion

Our results from our real-world data report on the first users’ experiences with the Omnipod5 HCL system in a pediatric setting within the NHS universal coverage. This study derived data from the use of HCL in an unselected diabetes population. Our data confirm that Omnipod5 shows a sustained improvement in glycemic management in HbA1c and sensor glucose outcomes at 3 and 6 months following Omnipod5 commencement. This was demonstrated by the significant improvement of TIR at 3 and 6 months (P < 0.001) and in HbA1c at 3 and 6 months (P < 0.001). We have also demonstrated improvements in percentage hypoglycemia, TBR, and TAR, which were consistent over 3- and 6-month intervals. These findings are comparable with those from existing first real-world data using Omnipod5 in adults within the NHS in the United Kingdom.⁷ This UK study involved 44 adults aged 27–53 years. The TIR increased from 54.4% to 67.4% after 4 weeks (P < 0.001), and the predicted HbA1c improved from 7.6% to 7.2% (P < 0.001). The positive impact of our results combined suggests a clinically relevant and important improvement in glycemic management for children and young people on Omnipod5. This is especially important in children, whose glucose levels can shift quickly due to factors such as growth, physical activity, and varied meal sizes.⁸ Our participants included all pediatric patients who were transitioned onto the Omnipod5, and there were no exclusion criteria as this was a real-world study. Previous literature had excluded participants based on recent hypoglycemia, hyperglycemia, or diabetic ketoacidosis.^9,10

The pivotal Omnipod5 trial¹⁰ conducted across 17 sites in the United States was a nonrandomized multicenter study that recruited a total of 235 participants ranging from 6 years to 69.8 years. They reported data from 111 children that showed a significant improvement of TIR from 52.5% to 68% (P < 0.0001) and HbA1c from 7.67% to 6.99% (P < 0.0001). Quality-of-life outcomes in the trial reported significant improvement in diabetes-specific psychosocial outcomes following introduction of Omnipod5 in adults. However, there were limitations to the study, specifically the lack of a control arm and the exclusion of patients with poor baseline glycemic management. To address some of these issues, an extension study¹¹ was conducted, which included 110 children, followed up for 21 months, and found that the initial results were sustained throughout the study period. Overall, there was a drop of 0.5% from baseline HbA1c and an increase in TIR of 13.5%, which remained stable. However, the generalizability to our UK population remains limited as the study was conducted in the United States, with different socioeconomic factors, and has an insurance-based system.

An NHS HCL real-world study of tubed HCL systems, which did not include Ominopd5, recently reported on improvements in fear of hypoglycemia scores and sleep disturbance scores among 2- to 18-year-olds, 12 months after introduction of tubed HCL pumps.^4,5 There has also been a first report of 50 adult Scottish patients who transitioned from Omnipod DASH to Omnipod5 were followed for a year and data paired before and after the switch.¹² Significant improvement was seen with median HbA1c falling from 8.6% (70 mmol/mol) to 7.5% (58 mmol/mol) and TIR increasing from 42% to 60%. Although this study was in an adult UK population and has a small sample size, it is encouraging to see that the results mirror those found in the studies conducted in the United States. Our study adds to the data already available by providing real-world Omnipod5 results for children in the United Kingdom. We have shown similar improvements to glycemic control, particularly HbA1c and TIR, with no increase in hypoglycemia compared with other populations using Omnipod5. The safety and efficacy were also comparable with other tubed HCL systems with the added physical benefits of a patch pump.

Improvement in quality of life for children who start using tubeless HCL systems such as Omnipod5 has been reported in some studies. Kulzer et al. reported that there was a general consensus that patients with T1DM prefer tubeless insulin pumps.¹³ This was reported to be due to fewer problems associated with insulin infusion sets and also due to reduced visibility of insulin pumps, lack of visible infusion sets, and improved body confidence due to the reduced size and ability to wear on different parts of the body. Tubeless HCL systems have the potential for revolutionizing the management of T1DM in children and young people. Patch pumps were also reported in other studies to offer an inherent benefit over tethered pumps, particularly for children. There was more flexibility in how the pump is worn, it does not need to be removed for bathing or swimming, and it cannot be accidentally dislodged by catching the tubing.^14,15 Additional physical benefits of the Omnipod5 reported include the smaller size and weight and the fact that the algorithm is localized in the patch so even if the handheld control is not within range, the pump will continue to function. In addition, once the pump is attached to the skin via the adhesive, the cannula is then inserted automatically following a command from the handheld controller, making the process of changing the pod significantly easier, particularly when dealing with energetic children.¹⁵

Limitations of our data include a large proportion of the participants characterized as White ethnicity. This is a higher proportion than published in the latest data from the National Pediatric Diabetes Audit from 2022 to 2023, which reported that 76.3% of pediatric patients within England and Wales identified as White.¹⁶ Our demographics may represent populations within our local region and the patients who are cared for by our services but may raise considerations about diversity and accessibility. However, real-world data from an unselected population provide strength to our results given that we had no exclusion criteria, and our participants should be a representative sample of our local cohort of patients. However, a relatively small sample size may limit the reach of interpretations. As this was from real-world data, limitations also include that users’ pump settings were not known such as use of difference optimal target settings and duration of auto mode. Other strengths include a minimum 6-month follow-up period. Recent real-world data⁷ from adults in the United Kingdom reported outcomes at just 4 weeks after using Omnipod5, while our data were reported after 3 and 6 months. This allowed for time to show significant improvements in HbA1c. The significant improvements in HbA1c and CGM glucose metrics by 3 months of use, which was maintained at 6 months, suggest an ongoing advantage of HCL systems over time. However, the need for long-term assessment to determine continued improvement over more “usual” care as well as cost effectiveness is needed.

The improvement in glycemic control, which we have demonstrated, may have longer-term implications for the UK NHS universal access to HCL and wider benefits such as quality-of-life improvements with a tubeless HCL system. Further research into longer term outcomes and population-based cost-efficiency of the Omnipod5 in a nationally funded health care system is essential. Our data confirm the safety and effectiveness of the Omnipod5 HCL system in the first pediatric users in the United Kingdom in a real-world setting of patients receiving universal access. Significant improvements in %TIR, TAR, TBR, and CV metrics were noted with reductions in hypoglycemia in children with T1DM. This offers another option for children and young people to access HCL technology and particularly for those who have a preference for a tubeless HCL system.

Authors’ Contributions

S.M.N. conceived the study. Z.T., V.S., K.Q., A.S. and G.S. collected the data. S.M.N. analysed the data and wrote the first draft. All authors approved the final draft.

Ethics Statement

It was not deemed necessary to gain ethical approval for this as the real-world study was undertaken as part of a service evaluation for CGM and HCL use within the organizations and did not affect patient care or direction of management. Data collection and quality-of-life surveys were evaluated and did not alter the course of patient care.

Footnotes

Author Disclosure Statement

S.M.N. has received speaker honoraria from Insulet and Sanofi. All other authors declared no conflict of interest.

Funding Information

No funding was received for this article.

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Omnipod5 Real-World Data from the First Pediatric Users’ Universal Coverage Under the UK National Health Service