Abstract
Background:
Pivotal trials of diabetes technologies have demonstrated glycemic improvements; however, these trials include patients of limited diversity and ranges of glycemic control. We assessed changes in glycemic control during the first 90 days of Omnipod 5 use in a real-world cohort of youth with type 1 diabetes (T1D).
Methods:
Youth 2–21 years with T1D initiating Omnipod 5 at two pediatric academic centers were included. Fourteen days of baseline (BL) continuous glucose monitoring (CGM) data were compared against data from the first 90 days of Omnipod 5 use. Outcome measures included changes in time in range (TIR), hemoglobin A1c (HbA1c), and CGM and insulin pump metrics based on the duration of Omnipod 5 use.
Results:
Among 195 youth (78.9% non-Hispanic White, 15.4% publicly insured, age 11.7 years, T1D duration 3.3 years) TIR increased 11%-points, from 49% to 61% (P < 0.001), and HbA1c decreased 0.5%-points, from 7.5% to 6.9% (P < 0.001). TIR improved within the first 9 days of Omnipod 5 use (p < 0.001) and did not change significantly thereafter (P = 0.1) despite decreases in user-initiated boluses (5.1 vs. 5.0, P = 0.01) and carbohydrate entries (4.2 vs. 4.1, P = 0.005) from days 1–9 to days 1–90. TIR improved 15%-points among youth with BL TIR <60% compared to a 5%-point increase for youth with BL TIR ≥60% (P < 0.001).
Conclusions:
Glycemic control improved within 9 days of Omnipod 5 initiation in this real-world cohort, and improvements were sustained over the first 90 days of use despite concomitant decreases in user-initiated boluses. These improvements were comparable to those observed in the pivotal trial.
Keywords: Type 1 diabetes, Automated insulin delivery, Minority youth, Inequities, Barriers, Glycemic control
Introduction
The use of automated insulin delivery (AID) systems among youth with type 1 diabetes (T1D) has steadily increased since the introduction of the first AID system in 2016.1 Clinical trials and real-world use of currently FDA approved AID systems improve glycemic control, decrease hemoglobin A1c (HbA1c), and increase time in range (TIR, 70–180 mg/dL) regardless of initial HbA1c at initiation of AID therapy.2–5
Despite technological advancements in diabetes care, racial/ethnic inequities in health outcomes for youth with T1D persist and are well documented. A 2018 assessment of 21,253 youth and adults in the T1D Exchange Registry (T1DX) demonstrated higher HbA1c values among individuals of lower socioeconomic status (SES) and African American race.6,7 The highest rates of acute complications, including diabetic ketoacidosis (DKA) and severe hypoglycemia, were also observed in those who identified as African American.6,7 Furthermore, diabetes technology use is lowest and HbA1c values are highest for those in the lowest SES quintile in the T1DX.8 Even though diabetes technology use is lower in non-White populations, these inequities have been shown to persist in AID use by race/ethnicity and insurance status.9
In the pivotal trial of youth ages 6 to 14 years, Omnipod 5, a tubeless, FDA-approved AID system, reduced HbA1c by 0.7% and increased TIR by 15% or 3.7 hours per day without increasing hypoglycemia.2 The Omnipod 5 was approved for use in youth ≥6 years of age on January 28, 2022 followed by a limited clinical launch for those already using Omnipod devices in February 2022 and a full clinical launch on August 8, 2022. Omnipod 5 was subsequently approved for ages 2 and up on August 22, 2022. Despite impressive outcomes in clinical trials, there was limited racial, ethnic, and socioeconomic diversity in this cohort, and real-world outcomes for Omnipod 5 users are limited. We report changes in glycemic control during the first 90 days of Omnipod 5 AID use among a racial, ethnic, and socioeconomically diverse cohort of youth ages 2–21 receiving care at two pediatric tertiary care diabetes centers.
Materials and Methods
This was a retrospective study of youth with T1D using the newly released Insulet Omnipod 5 insulin pump at two academic pediatric diabetes centers (Johns Hopkins [JHU] Pediatric Diabetes Center and the Children's Hospital of Philadelphia [CHOP]). Data were collected from early adopters of Omnipod 5, from May 2022 through November 1, 2022. The protocol was approved at both institutions in accordance with the Declaration of Helsinki and granted a waiver of consent.
Inclusion and exclusion criteria
Youth meeting the following criteria were included: age 2–21 years, diagnosis of T1D, and using the Omnipod 5 insulin pump with verifiable data available in Glooko. Youth reportedly using Omnipod 5 but without verifiable data in Glooko were not included. At JHU, all those with provider documented Omnipod 5 use (n = 162) were queried; 101 youth had verifiable data in Glooko before November 1, 2022. At CHOP, 366 youth were identified as early users through provider documentation. To limit data extraction to the necessary sample size, random sampling using an automatically generated code list was used to identify the 94 youth for inclusion at CHOP.
Data collection
Demographic characteristics (self-reported race and ethnicity, sex, and insurance type as a surrogate for SES) and clinical diabetes data were recorded from the electronic health record. Demographic characteristics of those using any generation of the Insulet insulin pump were collected at both centers. Clinical data for Omnipod 5 users included baseline (BL) HbA1c (laboratory or point-of-care measurement) from up to 180 days before initiation of Omnipod 5, prior insulin regimen (multiple daily injection [MDI], or pump and type of pump), and history at diabetes diagnosis. DKA at diagnosis was recorded based on International Society for Pediatric and Adolescent Diabetes (ISPAD) criteria defined as pH <7.3 and/or bicarbonate <15 mmol/L.10 Follow-up HbA1c levels closest to 3 months after Omnipod 5 initiation, but at minimum of 60 to 180 days after the start date, were recorded. Due to the increase in telemedicine use for diabetes care,11,12 some visits did not have an associated HbA1c level.
Continuous glucose monitor (CGM) parameter data were extracted from Dexcom Clarity for the 14 days before starting Omnipod 5 and from Glooko for days 1–9, 10–18, 19–27, and 1–90 after starting Omnipod 5. CGM parameters per international consensus guidelines were collected, including mean glucose, coefficient of variation (CV), TIR 70–180 mg/dL, time above range (>180 and >250 mg/dL), and time below range (<70 and <54 mg/dL). Insulin delivery data, including total daily insulin dose, total basal and bolus delivery, number of carbohydrate entries, and percent time in automated mode, activity mode, and manual mode, were recorded. Omnipod 5 start date was determined based on provider documentation and verified by a PDF-generated report in Glooko to identify the exact start data of automated mode. Study data were collected and managed using REDCap electronic data capture tools hosted at JHU and CHOP.13,14
Outcomes measured
The primary outcome was the change in TIR from 14 days pre-Omnipod 5 start (BL) compared to the first 90 days on Omnipod 5. Secondary outcomes included changes in HbA1c and CGM metrics and insulin pump data based on the duration of Omnipod 5 use.
Statistical analysis
A priori power analysis calculations were aimed to achieve 80% power with a type-1 two-tailed error rate of 5%. The primary outcome is 10%-points or greater difference in TIR. Assuming a standard deviation of TIR of 17% based on a small sample of pump users, an initial sample size of 39 was required. To have sufficient power to also detect a 0.5%-point or greater change in the secondary endpoint, HbA1c, with an assumed standard deviation of 1.6%-points,15 a sample size of 131 participants was needed. We estimated 33% attrition due to missing BL or follow-up HbA1c, resulting in final required sample size of 195.
Summary data are reported as median and interquartile range for continuous data or frequency and percentage for categorical data. Data were tested for normality using the Shapiro–Wilks test. Since data include many skewed variables, differences in paired data were tested using the Wilcoxon signed-rank test. Differences in patient characteristics were tested using the Wilcoxon rank-sum test for continuous variables or chi-squared or Fisher's exact test, as appropriate, for categorical variables. Multivariable regression models were fit for the primary outcome variable (change in TIR) and secondary outcome variable (change in HbA1c). Both models were adjusted for age, sex, race, duration of diabetes, site, DKA at diagnosis, HbA1c at diagnosis, insurance type, insulin regimen before Omnipod 5 initiation, and HbA1c or TIR before Omnipod 5 initiation. Analyses for this article were generated using SAS software v. 9.4 (SAS Institute, Cary, NC, 2020).
Results
Patient demographics and clinical characteristics
As of November 1, 2022, 1034 youth with T1D at both centers were using an Insulet insulin pump, and 528 (51.1%) were using Omnipod 5. Omnipod 5 uptake rates were higher in youth who identified as non-Hispanic White (55.2%) compared to youth of other racial/ethnic identities (39.7%, P < 0.0001). Omnipod 5 users were younger than those using older Insulet systems [median age 12.3 (9.4, 15.7) vs. 13.4 (10.0, 16.9) years, P = 0.0029] and had a shorter median duration of T1D [4.2 (2.0, 6.9) years vs. 5.0 (2.7, 8.0) years, P = 0.0002]. There was no significant difference in Omnipod 5 use by sex (49.8% female vs. 52% male, P = 0.42). There was a trend toward lower rates of uptake in publicly (46.1%) versus privately insured (52.4%) youth (P = 0.10).
As shown in Table 1, a total of 195 youth with T1D using Omnipod 5 were included in subsequent analyses (JHU 101, CHOP 94) using the inclusion and exclusion criteria described above. The median age of this cohort was 11.7 years (9.4, 14.6 years), 50.3% female, 78.9% NHW, 9.2% NHB, 3.6% Hispanic, 4.6% multiracial, and 15.4% on public insurance. At the time of study entry, the median duration of T1D was 3.3 years (1.5, 6), median BL HbA1c 7.5% (6.7, 8.3), TIR 49% (38, 64), average glucose 185 mg/dL (159, 212), and 85.1% were prior Omnipod pump users. There were some differences in the populations at each site, namely more youth at JHU represented racial/ethnic minorities and had a higher BL HbA1c, higher average CGM glucose, and lower TIR (Supplementary Table S1).
Table 1.
Baseline Characteristics of Subjects at Initiation of Omnipod 5
| All subjects (N = 195) |
Non-White or Hispanic (n = 37) |
White non-Hispanic (n = 154) |
|
|---|---|---|---|
| Median (IQR)/frequency (%) | Median (IQR)/frequency (%) | Median (IQR)/frequency (%) | |
| Female,a n (%) | 98 (50.3%) | 25 (67.6%) | 71 (46.1%) |
| Age (years) | 11.7 (9.4, 14.6) | 11.8 (9.3, 13.9) | 11.7 (9.6, 14.6) |
| Race/ethnicity, n (%) | |||
| Non-Hispanic White | 154 (78.9) | — | 154 (100) |
| Non-Hispanic Black | 18 (9.2) | 18 (48.6) | — |
| Multiracial | 9 (4.6) | 9 (24.3) | — |
| Hispanic | 7 (3.6) | 7 (18.9) | — |
| American Indian | 2 (1) | 2 (5.4) | — |
| Asian | 1 (0.5) | 1 (2.7) | — |
| Unknowna | 4 (2.1) | — | — |
| Public insurance, n (%)a | 30 (15.4) | 14 (37.8) | 15 (9.7) |
| Site = Johns Hopkins, n (%) | 101 (51.8) | 25 (67.6) | 76 (49.4) |
| Prior Omnipod user, n (%)a | 165 (85.1) | 30 (81.1) | 132 (86.3) |
| DKA at T1D diagnosis (n = 189), n (%) | 100 (52.9) | 25 (69.4) | 75 (50.3) |
| HbA1c at T1D diagnosis (%) (n = 185) | 11.3 (10.2, 13.3) | 12.2 (10.6, 14) | 11.2 (10.1, 13) |
| Duration of T1D (years) | 3.3 (1.5, 6) | 4.6 (2, 6.1) | 3.1 (1.5, 5.8) |
Four subjects with unknown race/ethnicity are excluded from stratified characteristics.
DKA, diabetic ketoacidosis; HbA1c, hemoglobin A1c; IQR, interquartile range; T1D, type 1 diabetes.
Glycemic outcomes associated with Omnipod 5 initiation
Compared to BL glycemic data, after 90 days of Omnipod 5 use, median TIR increased by 11%-points (from 49% to 61%, P < 0.001), median average CGM glucose decreased 15 mg/dL (from 185 to 170, P < 0.0001), and median HbA1c decreased 0.5%-point from 7.5% at BL to 6.9% (P < 0.001) (Table 2; Fig. 1). There was an improvement in all other CGM parameters, including time very low (<54 mg/dL), low (<70 mg/dL), high (>180 mg/dL), and very high (>250 mg/dL) (P < 0.01 for all analyses) (Fig. 2). There was no change in the CV. There was no statistically significant difference in glycemic outcomes by race for TIR and HbA1c (Supplementary Table S2).
Table 2.
Glycemic Control After Initiation of Omnipod 5
| n | BL | Days 1–9 | Days 10–18 | Days 19–27 | Days 1–90 | Median change BL to days 1–90 | P-valuea BL to days 1–90 | |
|---|---|---|---|---|---|---|---|---|
| Time in range (70–180 mg/dL) (%) | 185 | 49 (38, 64) | 60 (52, 70) | 63 (51, 72) | 64 (52, 71) | 61 (53, 72) | 11 | <0.0001 |
| HbA1c (%)b | 134 | 7.5 (6.7, 8.3) | — | — | — | 6.9 (6.4,7.7) | −0.45 | <0.0001 |
| Average CGM glucose (mg/dL) | 185 | 185 (159, 212) | 172 (154, 189) | 170 (152, 189) | 167 (152, 188) | 170 (153, 186) | −13 | <0.0001 |
| GMI (%) | 181 | 7.7 (7.1, 8.4) | — | — | — | 7.4 (7, 7.8) | −0.3 | <0.0001 |
| CV (%) | 184 | 38.5 (34.6, 42) | 36.4 (32.7, 40) | 36.3 (32.7, 40.3) | 36.4 (33.1, 40.7) | 38 (34.4, 40.6) | −0.5 | 0.15 |
| Total time high (>180 mg/dL) (%) | 185 | 47 (33, 61) | 38 (27, 47) | 36 (26, 47) | 34 (26, 47) | 37 (26, 46) | −10 | <0.0001 |
| Very high (>250 mg/dL) (%) | 185 | 19 (8, 32) | 12 (7, 20) | 12 (6, 21) | 12 (6, 20) | 13 (6, 20) | −5 | <0.0001 |
| High (181–250 mg/dL) (%) | 185 | 25 (21, 29) | 23 (19, 28) | 21.5 (18, 27) | 23 (18, 26) | 22 (19, 26) | −3 | <0.0001 |
| Total time low (<70 mg/dL) (%) | 185 | 2 (1, 3.4) | 1 (0, 2) | 1 (0, 2) | 1 (0, 2) | 1 (1, 2) | −0.2 | <0.0001 |
| Low (54–69 mg/dL) (%) | 185 | 1 (0.4, 3) | 1 (0, 2) | 1 (0, 2) | 1 (0, 2) | 1 (1, 2) | 0 | 0.0025 |
| Very low (<54 mg/dL) (%) | 185 | 0.5 (0, 1) | 0 (0, 0) | 0 (0, 0) | 0 (0, 0) | 0 (0, 0) | −0.2 | <0.0001 |
All values reported as median (IQR); n shows data available at BL and days 1–90.
Wilcoxon signed-rank test.
Baseline HbA1c was the last value collected within 6 months before initiating Omnipod 5. Follow-up HbA1c was the value collected closest to 90 days after initiation and between 2 and 6 months after initiation.
BL, baseline; CGM, continuous glucose monitor; CV, coefficient of variation; GMI, glucose management indicator.
FIG. 1.
Waterfall plots demonstrating individual changes in TIR (a) and HbA1c (b) during the first 90 days of Omnipod 5 use. HbA1c, hemoglobin A1c; TIR, time in range. Color images are available online.
FIG. 2.
Mean changes in time in (a), above (b), and below range (c) in addition to changes in HbA1c (d) during the first 90 days of Omnipod 5 Use. Median is represented by the center line. Upper and lower quartiles are represented by the top and bottom edges of box plot, respectively. Diamond represents the mean. The top and bottom whiskers represent the maximum and minimum observations within 1.5 times the IQR from the ends of the box. All other observed datapoints are plotted as outliers. IQR, interquartile range. Color images are available online.
Changes in glycemic outcomes were assessed in the first 9 days (3 pod wears), compared to the following two 9-day periods (days 10–18 and 19–27) at the start of Omnipod 5 use. TIR improved within the first 9 days of Omnipod 5 use (P < 0.001) and did not change significantly during days 10–18 or 19–27 (P > 0.1). As shown in Figure 3, improvements in glycemic outcomes and CGM parameters were realized in the first 9 days of Omnipod 5 use and remained stable for the duration of the acclimation period and through the first 90 days of use.
FIG. 3.
Mean changes in time in (a), above (b), and below range (c) according to duration of Omnipod 5 use. Median is represented by the center line. Upper and lower quartiles are represented by the top and bottom edges of box plot, respectively. Diamond represents the mean. The top and bottom whiskers represent the maximum and minimum observations within 1.5 times the IQR from the ends of the box. All other observed datapoints are plotted as outliers. Color images are available online.
We further stratified glycemic outcomes by BL TIR (Supplementary Table S3). Youth that started Omnipod 5 with a BL TIR <60% demonstrated greater improvements in glycemic outcomes than participants with a BL TIR ≥60%. Youth with a BL TIR <60% (n = 126) saw a median decrease in HbA1c of 0.5%, median increase in TIR of 15%-points, and a median decrease in average CGM glucose of 21 mg/dL (P < 0.001 for all analyses).
Insulin pump data
The median percent time in automated mode was high throughout the study but decreased from 98.0% on days 1 to 9 (90.0, 100.0) to 95.0% (89.0, 98.0) in days 1 to 90 (P = 0.0009). Activity mode was only used at a median 1.0% (0, 3.0%) during the 90-day period and did not change throughout the 90-day period. Percent basal insulin increased by a median 2%-points from days 1 to 9 [51% (45, 57)] to days 1 to 90 [53% (47, 59)] (P < 0.0001), while the percent bolus insulin decreased (P < 0.0001). The median number of user-initiated boluses per day decreased from 5.1 (4.0, 7.1) per day during days 1 to 9 to 5.0 (3.8, 6.8) during days 1 to 90 (P = 0.01), as did the number of carbohydrate entries per day, which fell from 4.2 (3.3, 5.6) in days 1 to 9 to 4.1 (3.3, 5.6) at days 1 to 90 (P = 0.005). Percent bolus overrides also increased from days 1 to 9 [3.3% (0, 12.5)] to days 1 to 90 [5.9% (0.8, 17.9)] (P < 0.0001) (Supplementary Table S4).
Multivariable analysis of glycemic outcomes
Multivariable analysis was conducted to identify factors associated with improvement in average glycemic control at days 1–90. Multivariable analysis adjusting for age, sex, race (White vs. non-White), insurance type, site, BL glycemic variables (HbA1c, TIR), time in automated mode, duration of diabetes, history of DKA and HbA1c at diagnosis, and prior insulin delivery method demonstrated that BL TIR (β = −0.40, 95% confidence interval; CI [−0.5 to −0.3], P < 0.0001) and time spent in automated mode (β = 0.17, 95% CI [0.1–0.3], P = 0.0002) were the only factors that predicted the magnitude of improvement in TIR. For each 10%-point increase in automated mode use, there was an associated 1.8%-point increase in TIR with Omnipod 5 use (P = 0.0002). Participants with lower BL TIR had a larger improvement in TIR with Omnipod 5 use. Each 10%-point decrease in BL TIR was associated with a 4%-point larger increase in the overall improvement with Omnipod 5 use (P < 0.0001). Likewise, for each percentage point increase in BL HbA1c at the start of Omnipod 5, there was a 0.31%-point larger reduction in HbA1c by 90 days of Omnipod 5 use. Youth with the highest HbA1c and lowest TIR at initiation of Omnipod 5 had the greatest improvements in HbA1c and TIR. These improvements are independent of age, sex, race, insurance coverage, and site in this early Omnipod 5 use cohort.
Discussion
In this real-world cohort of youth with T1D, we demonstrated improvements in glycemic control during the first 90 days of Omnipod 5 use comparable to changes noted during the Omnipod 5 pivotal trial.2 In the nonrandomized prospective Omnipod 5 pivotal trial, TIR increased by 15 percentage points and HbA1c decreased by 0.7%-points among youth ages 6 to 13 with T1D, while TIR increased by 12%-points and HbA1c decreased by 0.4%-point among those 14 years of age and older.2 Aggregate data from real-world pediatric Omnipod 5 users, which did not include BL glycemic data and were presented in abstract form, also demonstrated TIR ranging from 67% to 74% in the pediatric population.16 Despite lower BL TIR and a higher BL HbA1c in our cohort, TIR increased by 11%-points or 2.6 h/day and HbA1c decreased by 0.5%-point. Improvements in TIR occurred within 9 days of Omnipod 5 initiation and were sustained throughout the 90-day study period despite concomitant decreases in user-administered boluses and carbohydrate entries.
Given that there is often underrepresentation of individuals of color in randomized control trials, as well as overrepresentation of individuals with optimal glycemic control,2,3,17,18 real-world studies provide more generalizable findings. Notably, 85.7% of participants in the Omnipod 5 pivotal trial identified as non-Hispanic White and only 1.8% of participants identified as non-Hispanic Black. Nearly 90% were prior insulin pump users, and individuals with a BL HbA1c >10% were excluded from participation. Information regarding insurance type and household income was not reported. The demographic characteristics of research participants in the Omnipod 5 pivotal trial and improvements in glycemia are similar to those reported in pivotal trials of other AID systems in T1D.2,3,17–19 While 84.5% of participants in randomized controlled trials of AID systems in the United States identified as non-Hispanic White, 73.5% of individuals in the general T1D population, as captured in the T1D Exchange Quality Improvement Collaborative, identified as non-Hispanic White.6,20 The trend toward lower rates of Omnipod 5 use among publicly insured youth in this early adopter cohort suggests that insurance coverage is a barrier to AID uptake. Promoting early adoption of AID coverage among public health care payor systems is important for supporting equitable access.
Among youth with T1D in the United States, the mean HbA1c is 8.3% in 6–12-year olds and 8.7% among 13–17-year olds, while the BL HbA1c of clinical trial participants ranges from 7.4% to 7.9%.2,3,9,17–19,21,22–26 Among all FDA approved AID systems, improvements in TIR among youth and adults participating in pivotal trials have ranged from 10 to 15%-points2,3,17,18,21 and HbA1c improvements have ranged from 0.4 to 0.7%-point.2,3,17,21 Real-world studies of these same devices have yielded 7–10%-point improvements in TIR and 0.2–0.4%-point decreases in the glucose management indicator,2,3,17–19,21 yet it is difficult to assess the generalizability of clinical trial data to real-world populations.1 With less than 20% of youth with T1D attaining recommended glycemic targets1 and with greater inequities in glycemic outcomes among historically minoritized youth,6,9 real-world AID data provide important insights while also capturing representative T1D populations. Despite significant glycemic improvements in those using AID system, further work is needed to support people with diabetes in attaining recommended glycemic targets.
The use of CGM and insulin pumps for pediatric T1D management predicts superior glycemic control9,27 and real world, population-based data have not shown any association between pump use and DKA.28 Our findings of greater improvements in glycemia among those with the lowest BL TIR and highest HbA1c align with several other studies.29,30 Collectively, these findings indicate that elevated BL HbA1c should not be a barrier to AID use. With evidence suggesting that differences in positive expectancy of AID systems are unlikely to explain known inequities in use,31 ensuring that provider prescribing practices facilitate access to AID systems is important for promoting improved and equitable glycemic outcomes for all youth with T1D.
There are several limitations to this study. This is a cohort of early adopters of Omnipod 5 technology, and thus, the mean HbA1c of this cohort may be lower than the general population of youth with T1D and may not be representative of all Omnipod 5 users. In addition, the small sample size of non-White individuals and publicly insured youth limited the analysis between different racial/ethnic groups and insurance types. Inherent to any retrospective study, there were limitations on data availability. Specifically, there were some participants who did not have a BL or follow-up HbA1c within the specified time, and some had gaps in their Glooko data due to widespread data gaps in the system for several days in October and November 2022. However, given that we analyzed the full 90-day period of CGM data, these missing Glooko data accounted for less than 5% of participants' CGM data. Despite these limitations, the strength of this study includes the first report of real-world Omnipod 5 use data to assess improvements from BL in a population of youth with T1D.
Conclusions
In summary, we demonstrated glycemic improvements in percent TIR and HbA1c in early real-world pediatric users of the Omnipod 5 AID system. Notably, these improvements were seen within 9 days of AID initiation and were sustained over the first 90 days of use despite modest decreases in user-initiated boluses. The greatest improvements in TIR were seen among new Omnipod 5 users who started with a higher BL HbA1c and lower percent TIR. Encouraging use of advanced diabetes technologies and specifically AID in the pediatric and adolescent population with T1D may lead to overall improved glycemic control and long-term outcomes for this population. Ensuring access to these systems for the racial/ethnic minority and publicly insured youth with historically disparate glycemic outcomes may help improve health equity in the management of T1D.
Supplementary Material
Authors' Contributions
B.E.M., E.A.B., and R.M.W. formulated the clinical question. J.L.D., A.R., S.M., A.Z., and R.S. collected data. B.E.M. and R.M.W. wrote the article with contributions from J.L.D., S.M., and E.A.B. E.A.B. completed the statistical analyses and created the figures and tables. J.L.D., A.R., R.S., and A.Z. made critical contributions to the article. All authors edited, reviewed, and approved the article.
Author Disclosure Statement
B.E.M. is supported by the National Institutes of Health (PI: B.E.M., NIH: K23DK129827) and has received investigator-initiated research support from Tandem Diabetes Care, Inc., the Cystic Fibrosis Foundation, industry sponsored research support from Medtronic, and research supplies from Dexcom, Inc., and Digostics. R.M.W. is supported by the National Institutes of Health (1R01DK134955 and 1R01EY033233). R.M.W. is the site PI of a Novo Nordisk sponsored clinical trial.
Funding Information
No funding was secured for this study. The authors received no support from Insulet.
Supplementary Material
References
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