Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, ...on-body automated insulin delivery system with customizable glycemic targets.
This single-arm, multicenter, prospective study enrolled 112 children (age 6-13.9 years) and 129 adults (age 14-70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA
and percent time in sensor glucose range 70-180 mg/dL ("time in range").
A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA
was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% 60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol,
< 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% 55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol,
< 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both
< 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median interquartile range: 2.00% 0.63, 4.06 to 1.09% 0.46, 1.75,
< 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure.
This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA
levels and time in target glucose range with a very low occurrence of hypoglycemia.
Aims: The aim of the study was to evaluate the social impact of the COVID-19 pandemic on youth with diabetes in Northeast Ohio from March 2020 through October 2022, and assess for disparate impact on ...minority and socially disadvantaged groups.
Methods: An email survey was distributed to 609 families of children with diabetes who met the inclusion criteria: age 7-20 years, followed by our clinic, and T1DM (duration 2+ years) or T2DM (duration 1+ years) prior to the pandemic. The survey asked several questions in 5 categories (housing, guardian's job loss, medical care disruption, schooling disruption and death of household member from COVID-19). Responding yes to any question in a category constituted an adverse social event (ASE). COVID-19 infection, hospitalization and vaccination status were collected. Between group differences were examined with a Fisher's Exact Test.
Results: Sixty two parents (10%) answered the survey, of whom 33 (53%) reported no ASE, 22 (35%)reported one ASE, and 7 (11%) reported 2 or more ASEs. Six respondents were Black and five were Hispanic. Among Black participants 1 (17%) had 1 ASE and 1 (17%) had 2 or more ASE, which was not statistically different than White participants. Among Hispanic participants 2 (40%) had one ASE and2 (40%) had 2 or more ASEs, which was numerically higher than the rates seen in non-Hispanic participants and approached statistical significance, p=0.068. Rates of ASE did not differ by insurance type or income level. Rates of COVID-19 infection and hospitalization did not differ between racial and ethnic groups. COVID 19 vaccination occurred at similar rates for Black and White participants; however, only 20% of Hispanic children received a COVID-19 vaccination, compared to 70% of non-Hispanic participants, p=0.04.
Conclusion: Forty six percent of children with diabetes experienced one or more ASE during theCOVID-19 pandemic. Our survey suggests that rates of ASE may have been higher in Hispanicchildren, who were also less likely to receive a COVID-19 vaccine.
Disclosure
R.Abdul wahed: None. S.Ronis: None. S.A.Macleish: Speaker's Bureau; Insulet Corporation. J.R.Wood: Research Support; Insulet Corporation, Boehringer-Ingelheim, MannKind Corporation. S.Malay: None. K.A.Kutney: None.
Objective: Insulin degludec (IDeg) is an ultra-long acting insulin that gives more flexibility with dose timing. Studies comparing the efficacy of IDeg to insulin glargine (IGlar) have conflicting ...results. Our aim was to compare glycemic control (HbA1c and fasting glucose) and complications (hypoglycemia, DKA) before and after switch from IGlar to IDeg in a larger sample over a longer (up to 3 years) time period. Methods: Retrospective chart review from 2016-2020 was performed for patients with T1D ≤18 years old who switched from IGlar to IDeg. IRB approval was obtained with waiver of consent. Repeated measures analysis was performed on unbalanced data, with paired analysis of group effect on DKA and hypoglycemia. Results: There were 88 patients that met inclusion criteria. At switch, mean (SD) diabetes duration was 6.2 (3.4) years, HbA1c 9.8 (2.1)%. Mixed modelling showed no effect of insulin switch on glycemic control. There were fewer hypoglycemic episodes on IGlar. There were fewer patients with DKA in 6 months after switch to IDeg than 6 months prior on IGlar (6.8% vs. 15.9%, McNemar p-value: <0.0001). Conclusions: Although there was no change in glycemic control, patients with suboptimally controlled T1D had significantly less DKA after switch to IDeg than while on IGlar. Increased hypoglycemia after switch may be due to improved adherence with daily dosing.
Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We ...conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population.
A total of 80 children aged 2.0-5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy.
There were no episodes of severe hypoglycemia or diabetic ketoacidosis. By study end, HbA1c decreased by 0.55% (6.0 mmol/mol) (P < 0.0001). Time with sensor glucose levels in target range 70-180 mg/dL increased by 10.9%, or 2.6 h/day (P < 0.0001), while time with levels <70 mg/dL declined by median 0.27% (P = 0.0204).
Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline.
Type 1 diabetes (T1D) can lead to significant emotional distress and impaired quality of life (QoL). Hybrid closed-loop (HCL) technology seeks to relieve this burden, a goal with equal importance to ...improving glycemic outcomes. We evaluated change in QoL outcomes for adults (mean±SD, age 39±13y, T1D duration 19±12y, and baseline A1C 7.1±0.9%) before and after a 3-month outpatient study of HCL therapy with the Omnipod 5 System. Participants (N=115) completed validated assessment tools to capture various aspects of diabetes-related and generic QoL: the T1D Distress Survey (T1DDS), Hypoglycemic Confidence Scale (HCS), and World Health Organization Well-Being Index (WHO-5). Though QoL was relatively high at baseline across all 3 measures, we observed significant improvements in diabetes-related QoL with reduced T1DDS and increased HCS scores after 3 months of system use (Table). Among the T1DDS subscales, significant improvements were seen in powerlessness (change: ‑0.27), management distress (-0.18), hypoglycemia distress (-0.21), and eating distress (-0.24, all p<0.001). Generic QoL (WHO-5) was unchanged over the study period. In addition to glycemic efficacy and safety of the Omnipod 5 System (reported previously), these results reveal a significant improvement in QoL for adults with T1D and suggest features of the system may alleviate some of the burden associated with living with T1D.
Type 1 diabetes (T1D) is a lifelong disease that requires constant monitoring. New technologies seeking to relieve this burden must be user-friendly and provide treatment satisfaction to enable ...widespread adoption, glycemic benefit, and long-term success. We assessed these parameters for the Omnipod 5 Automated Insulin Delivery System during a 3-month outpatient study of the system. Participants (N=240) with T1D aged 6-70y completed validated assessment tools at study start and end, including the Insulin Device Satisfaction Survey (IDSS), Diabetes Treatment Satisfaction Questionnaire (DTSQ), and System Usability Scale (SUS). Parents/guardians of participants aged 6-11.9y (children, N=83) and 12-17.9y (teens, N=42) were assessed as appropriate. Participants were aged (mean±SD) 25±17y, with T1D duration 12±11y and baseline A1C 7.4±0.9%. Perceived usability and satisfaction with the treatment regimen and device were significantly improved with the study system compared to prior therapy (Table). Improvements were also seen in the IDSS subscales for burden and inconvenience (both p<0.05). In addition to glycemic efficacy and safety of the Omnipod 5 System (reported previously), these results reveal significant improvement in usability and satisfaction, suggesting that this system may alleviate some of the burdens associated with existing treatment options for T1D.
Type 1 diabetes (T1D) can lead to significant emotional distress and impair quality of life (QoL). Hybrid closed-loop (HCL) technology seeks to relieve this burden, a goal with equal importance to ...improving glycemic outcomes. We evaluated change in QoL outcomes for children (6.0-11.9y) and teens (12.0-17.9y) with T1D and their parents/guardians before and after a 3-month study of HCL therapy with the Omnipod 5 System. Validated assessment tools administered included diabetes-related QoL (PAID and HCS) and generic QoL (PSQI and WHO-5) questionnaires. Children (n=83) and teens (n=42) were (mean±SD): age 9±2y and 14±2y, with T1D duration 4±2y and 7±3y and A1C 7.5±0.9% and 7.9±1.0%, respectively. Responses revealed significantly reduced diabetes distress for all groups (Table). Also, parents of children reported significant improvement in overall well-being (WHO-5), hypoglycemic confidence (HCS) and in 3 PSQI sleep subscales: quality (change: ‑0.43±0.83, p<0.01), disturbance (‑0.18±0.58, p<0.01), and duration (‑0.28±1.00, p<0.01). In this 3-month study, the Omnipod 5 System reduced diabetes distress for youth and their parents. The most striking improvements in QoL were seen in parents of children, a group in great need of solutions to help them care for their children without negatively affecting their own QoL.
•Adults with T1D used an investigational tubeless Omnipod 5 AID system for 3 months.•Participants saw improvements in diabetes-related psychosocial outcomes with AID.•Even with positive outcomes with ...prior therapy, improvements were still observed.•Improvements were not consistently associated with any baseline characteristics.•Positive psychosocial outcomes with AID systems support adoption and long-term use.
To evaluate psychosocial outcomes for adults with type 1 diabetes (T1D) using the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System.
A single-arm, multicenter (across the United States), prospective safety and efficacy study of the tubeless AID system included 115 adults with T1D. Participants aged 18–70 years completed questionnaires assessing psychosocial outcomes – diabetes distress (T1-DDS), hypoglycemic confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), diabetes treatment satisfaction (DTSQ), and system usability (SUS) – before and after 3 months of AID use. Associations among participant characteristics, psychosocial measures and glycemic outcomes were evaluated using linear regression analyses.
Adults using the tubeless AID system demonstrated improvements in diabetes-specific psychosocial measures, including diabetes distress, hypoglycemic confidence, insulin delivery satisfaction, diabetes treatment satisfaction, and system usability after 3 months (all P < 0.001). No changes in general well-being or sleep quality were observed. The psychosocial outcomes assessed were not consistently associated with baseline participant characteristics (i.e., age, sex, diabetes duration, glycemic outcomes including percent time in range 70–180 mg/dL, percent time below range < 70 mg/dL, hemoglobin A1c, or insulin regimen).
Use of the Omnipod 5 AID system was associated with significant improvements in diabetes-related psychosocial outcomes for adults with T1D.
Clinical Trials Registration Number: NCT04196140.
The Omnipod 5 AID System is a tubeless hybrid closed-loop system with on-body operation and customizable glucose targets. Safe and effective system use was demonstrated in children aged 2-5.9y with ...type 1 diabetes (T1D) during a 3-mo pivotal study. To evaluate durability of glycemic benefit, we analyzed results from 9mo of an ongoing extension study, totaling 12mo of system use. In the pivotal study, participants used the system for 3mo at home, after 14d of their standard therapy (ST, pump or multiple daily injections) . They were then invited to participate in the extension study. Safety endpoints were occurrence of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) . Glycemic outcomes were A1C and percent time in ranges (TIR 70-180 mg/dL, TBR <70 mg/dL, TAR >180 mg/dL) during 3-mo AID intervals compared with ST. All pivotal trial participants (N=80) , aged (mean±SD) 4.7±1.0y with T1D duration 2.3±1.1y and total daily insulin of 14±4U (range: 5.3-27U) at baseline, enrolled in the extension. Improved outcomes were observed for up to 12mo, including lower A1C and greater TIR during each AID interval compared with ST (all p<0.05, Table) . There were no episodes of DKA or SH in the 12-mo study. The safety and improved glycemic outcomes from the initial 3mo pivotal study persisted for an additional 9mo, indicating the potential long-term benefit of the Omnipod 5 System in very young children with T1D.
Disclosure
D.Desalvo: Consultant; Dexcom, Inc., Insulet Corporation, Research Support; Insulet Corporation. D.W.Hansen: None. T.T.Ly: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. Omnipod 5 in preschoolers study group: n/a. B.W.Bode: Advisory Panel; CeQur SA, MannKind Corporation, Medtronic, Novo Nordisk, Zealand Pharma A/S, Consultant; Bigfoot Biomedical, Inc., Research Support; Abbott, Beta Bionics, Inc., Dexcom, Inc., Diasome, Dompé, Eli Lilly and Company, Insulet Corporation, IQVIA Inc., Jaeb Center for Health Research, Medtronic, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanvita Medical, Senseonics, ViaCyte, Inc., Speaker's Bureau; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc., Stock/Shareholder; AgaMatrix, Glytec, LLC. G.P.Forlenza: Advisory Panel; Lilly, Medtronic, Consultant; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care, Inc. L.M.Laffel: Advisory Panel; Medtronic, Roche Diabetes Care, Consultant; Boehringer Ingelheim International GmbH, Dexcom, Inc., Dompé, Insulet Corporation, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk, Provention Bio, Inc. B.A.Buckingham: Advisory Panel; Arecor, Lilly Diabetes, Medtronic, Other Relationship; Insulet Corporation, Research Support; Insulet Corporation, Lilly Diabetes, Medtronic. A.B.Criego: Advisory Panel; Insulet Corporation, Other Relationship; Medscape, Sanofi, Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Medtronic. M.Schoelwer: Other Relationship; Dexcom, Inc., Research Support; Insulet Corporation, Medtronic, Tandem Diabetes Care, Inc. S.A.Macleish: Advisory Panel; Insulet Corporation. J.Sherr: Advisory Panel; Bigfoot Biomedical, Inc., Cecelia Health, Insulet Corporation, Medtronic, Vertex Pharmaceuticals Incorporated, Consultant; Insulet Corporation, Lexicon Pharmaceuticals, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Jaeb Center for Health Research, JDRF, Medtronic, National Institute of Diabetes and Digestive and Kidney Diseases, Speaker's Bureau; Lilly Diabetes.
Funding
Insulet Corporation
Background: The incidence of type 1 diabetes (T1D) and overweight/obesity is on the rise. Previous studies showed altered gut microbiota in children with T1D where gut microbial differences between ...obese and lean children without diabetes were reported. The purpose of the study was to characterize the microbial composition of lean and overweight children with T1D at disease onset in comparison to healthy controls.
Methods: We enrolled 26 children with T1D at disease onset including 15 lean and 11 overweight T1D and compared them with age, gender and BMI matched 14 lean and 8 overweight controls. Stool swabs were collected and DNA extraction was performed using Qiagen DNA mini kit. Bacterial regions v3, v4 were amplified using 16s primers. Amplicons were cleaned, barcoded, size selected and sequencing was completed on Ion Torrent S5 sequencer.
Results: The four most abundant phyla in both groups were Proteobacteria, Firmicutes, Bacteroidetes and Actinobacteria. At the genus level, noted significant increase in pro-inflammatory microbes such as Serratia in T1D compared to controls without diabetes (P value= 0.047). Overweight T1D had marked decrease in the beneficial genus Lactobacillus compared to overweight controls. Similar observation was reported when lean T1D was compared to matched lean controls. Although not significant, anti-inflammatory genera like Clostridium had lower relative abundance in obese T1D compared to their lean counterparts. At the species level, when overweight T1D were compared to their matched controls, there was a marked reduction in L. brevis and L. Zeae known for their anti-inflammatory effects (P value = 0.038, 0.046 respectively).
Conclusion: Our study showed alterations in the gut microbiome in children with T1D with significant increase in pro-inflammatory microbes. Additionally, being overweight negatively impacted the microbiome.
Disclosure
S.B. Gowda: None. R.M. Farrell: Research Support; Self; TODAY study. Stock/Shareholder; Self; Dexcom, Inc., Tandem Diabetes Care. S.A. MacLeish: None. I. Salem: None. M.A. Retuerto: None. M.A. Ghannoum: None.
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