IMPORTANCE Hypoglycemia is a critical obstacle to the care of patients with type 1 diabetes. Sensor-augmented insulin pump with automated low-glucose insulin suspension has the potential to reduce ...the incidence of major hypoglycemic events. OBJECTIVE To determine the incidence of severe and moderate hypoglycemia with sensor-augmented pump with low-glucose suspension compared with standard insulin pump therapy. DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial involving 95 patients with type 1 diabetes, recruited from December 2009 to January 2012 in Australia. INTERVENTIONS Patients were randomized to insulin pump only or automated insulin suspension for 6 months. MAIN OUTCOMES AND MEASURES The primary outcome was the combined incidence of severe (hypoglycemic seizure or coma) and moderate hypoglycemia (an event requiring assistance for treatment). In a subgroup, counterregulatory hormone responses to hypoglycemia were assessed using the hypoglycemic clamp technique. RESULTS Of the 95 patients randomized, 49 were assigned to the standard-pump (pump-only) therapy and 46 to the low-glucose suspension group. The mean (SD) age was 18.6 (11.8) years; duration of diabetes, 11.0 (8.9) years; and duration of pump therapy, 4.1 (3.4) years. The baseline rate of severe and moderate hypoglycemic events in the pump-only group was 20.7 vs 129.6 events per 100 patient months in the low-glucose suspension group. After 6 months of treatment, the event rates decreased from 28 to 16 in the pump-only group vs 175 to 35 in the low-glucose suspension group. The adjusted incidence rate per 100 patient-months was 34.2 (95% CI, 22.0-53.3) for the pump-only group vs 9.5 (95% CI, 5.2-17.4) for the low-glucose suspension group. The incidence rate ratio was 3.6 (95% CI, 1.7-7.5; P <.001). There was no change in glycated hemoglobin in either group: mean, 7.4 (95% CI, 7.2-7.6) to 7.4 (95% CI, 7.2-7.7) in the pump-only group vs mean, 7.6 (95%, CI, 7.4-7.9) to 7.5 (95% CI, 7.3-7.7) in the low-glucose suspension group. Counterregulatory hormone responses to hypoglycemia were not changed. There were no episodes of diabetic ketoacidosis or hyperglycemia with ketosis. CONCLUSIONS AND RELEVANCE Sensor-augmented pump therapy with automated insulin suspension reduced the combined rate of severe and moderate hypoglycemia in patients with type 1 diabetes. TRIAL REGISTRATION anzctr.org.au Identifier: ACTRN12610000024044
To evaluate the feasibility and efficacy of a fully integrated hybrid closed-loop (HCL) system (Medtronic MiniMed Inc., Northridge, CA), in day and night closed-loop control in subjects with type 1 ...diabetes, both in an inpatient setting and during 6 days at diabetes camp.
The Medtronic MiniMed HCL system consists of a fourth generation (4S) glucose sensor, a sensor transmitter, and an insulin pump using a modified proportional-integral-derivative (PID) insulin feedback algorithm with safety constraints. Eight subjects were studied over 48 h in an inpatient setting. This was followed by a study of 21 subjects for 6 days at diabetes camp, randomized to either the closed-loop control group using the HCL system or to the group using the Medtronic MiniMed 530G with threshold suspend (control group).
The overall mean sensor glucose percent time in range 70-180 mg/dL was similar between the groups (73.1% vs. 69.9%, control vs. HCL, respectively) (P = 0.580). Meter glucose values between 70 and 180 mg/dL were also similar between the groups (73.6% vs. 63.2%, control vs. HCL, respectively) (P = 0.086). The mean absolute relative difference of the 4S sensor was 10.8 ± 10.2%, when compared with plasma glucose values in the inpatient setting, and 12.6 ± 11.0% compared with capillary Bayer CONTOUR NEXT LINK glucose meter values during 6 days at camp.
In the first clinical study of this fully integrated system using an investigational PID algorithm, the system did not demonstrate improved glucose control compared with sensor-augmented pump therapy alone. The system demonstrated good connectivity and improved sensor performance.
Neuropsychiatric systemic lupus erythematosus (NPSLE) varies in presentation and is one of the leading causes of morbidity and mortality among patients with SLE. This study determined the most ...critical serum biomarkers for the development of NPSLE as they may have clinical utility prior to the onset of neuropsychiatric symptoms. We retrospectively analyzed 35 NPSLE patients, 34 SLE patients, 20 viral meningitis (VM) patients, and 16 relapsing-remitting multiple sclerosis (MS) patients. We measured anti-suprabasin antibodies concentrations in serum by using Luciferase immunoprecipitation system (LIPS) assay. The serum concentrations of cytokines/chemokines were measured by using multiplex bead-based assay. We found serum FGF-2 level was significantly higher in the NPSLE group compared to the SLE group and the healthy control group. The anti-suprabasin antibody relative concentration (SRC) has high positive predictive values for the development of NPSLE. The most essential biomarkers are VEGF, anti-suprabasin antibodies, sCD40L, IL-10, GRO, MDC, IL-8, IL-9, TNF-α, MIP-1α.
The Omnipod 5 AID System is a novel tubeless hybrid closed-loop system that allows for personalized therapy through customizable glucose targets from 110-150mg/dL in 10mg/dL increments. The System ...enables automatic upload of data for all users initiating the system, facilitating unprecedented access to evaluate real-world outcomes. Continuous glucose monitoring (CGM) and insulin data from Omnipod 5 users with type 1 diabetes (T1D) aged <18y in the US with ≥90 days of data available in the cloud-based data management system were included. Data from 3,369 users with sufficient CGM data (≥75% of days with ≥220 readings) and using the lowest target (110mg/dL) for ≥50% of the time, aged <6y (n=182), 6 to 12y (n=2,050), and 13 to 17y (n=1,137) were available at the time of analysis. Users were aged mean±SD 10.9±3.4y with median 146 days of system use. Outcomes are shown in the Table for each age group. Median time in target range (70-180mg/dL) was 74.0%, 70.7%, and 67.1% for each age group, respectively. Time <70mg/dL in each age group was low: median 2.7%, 1.8%, and 1.2%, respectively. These results are the first to demonstrate that in over 3,000 children and adolescents using the Omnipod 5 System in a real-world setting, highly favorable glycemic outcomes are achievable and are similar to those first reported in pivotal trials.
Disclosure
J.Sherr: Advisory Panel; Bigfoot Biomedical, Inc., Insulet Corporation, Medtronic, Vertex Pharmaceuticals Incorporated, Cecelia Health, StartUp Health T1D Moonshot, Consultant; Bigfoot Biomedical, Inc., Insulet Corporation, Medtronic, Lilly, Research Support; Insulet Corporation, Medtronic, NIH - National Institutes of Health, Juvenile Diabetes Research Foundation (JDRF), Speaker's Bureau; Insulet Corporation, Zealand Pharma A/S, Lilly, Medtronic. D.Desalvo: Consultant; Dexcom, Inc., Research Support; Insulet Corporation. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. K.Snow: Employee; Insulet Corporation. J.J.Mendez: None. I.Hadjiyianni: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation, Eli Lilly and Company. T.T.Ly: Employee; Insulet Corporation.
Funding
Insulet Corporation
The Omnipod 5 AID System is a novel tubeless hybrid closed-loop system that allows for personalized therapy through customizable glucose targets from 110-150mg/dL in 10mg/dL increments. The System ...enables automatic upload of data for all users initiating the system, facilitating unprecedented access to evaluate real-world outcomes. Continuous glucose monitoring (CGM) and insulin data from Omnipod 5 users with type 1 diabetes (T1D) aged ≥18y in the US with ≥90 days of data available in the cloud-based data management system were included. Data from 5,968 users with sufficient CGM data (≥75% of days with ≥220 readings) and using the lowest target (110mg/dL) for ≥50% of the time, aged 18 to 25y (n=840), 26 to 49y (n=3,127), 50 to 64y (n=1,423), and ≥65y (n=578) were available at the time of analysis. Users were aged mean±SD 42.8±15.0y with median 139 days of system use. Outcomes are shown in the Table for each age group. Median time in target range (70-180mg/dL) was 69.6%, 73.0%, 74.2%, and 77.4% for each age group, respectively. Time <70mg/dL in each age group was low: median 1.0%, 1.0%, 1.0%, and 0.9%, respectively. These results are the first to demonstrate that in over 5,900 adults using the Omnipod 5 System in a real-world setting, highly favorable glycemic outcomes are achievable and are similar to those first reported in a pivotal trial.
Disclosure
R.Lal: Advisory Panel; Provention Bio, Inc., Consultant; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Deep Valley Labs, Gluroo, Tidepool, PhysioLogic Devices, Morgan Stanley. G.Aleppo: Advisory Panel; Medscape, Consultant; Bayer Inc., Insulet Corporation, Research Support; Dexcom, Inc., Eli Lilly and Company, Emmes, Insulet Corporation, Fractyl Health, Inc., WellDoc, Speaker's Bureau; Dexcom, Inc. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. K.Snow: Employee; Insulet Corporation. J.J.Mendez: None. I.Hadjiyianni: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation, Eli Lilly and Company. T.T.Ly: Employee; Insulet Corporation.
Funding
Insulet Corporation
Automated insulin delivery (AID) has rarely been studied in adults with type 2 diabetes. We tested the feasibility of using AID for type 2 diabetes with the Omnipod 5 System in a multicenter ...outpatient trial.
Participants previously were using either basal-only or basal-bolus insulin injections, with or without the use of a continuous glucose monitor (CGM), and had a baseline HbA1c ≥8% (≥64 mmol/mol). Participants completed 2 weeks of CGM sensor data collection (blinded for those not previously using CGM) with their standard therapy (ST), then transitioned to 8 weeks of AID. Participants who previously used basal-only injections used the AID system in manual mode for 2 weeks before starting AID. Antihyperglycemic agents were continued at clinician discretion. Primary safety outcomes were percentage of time with sensor glucose ≥250 mg/dL and <54 mg/dL during AID. Additional outcomes included HbA1c and time in target range (TIR) (70-180 mg/dL).
Participants (N = 24) had a mean (± SD) age of 61 ± 8 years, baseline HbA1c of 9.4% ± 0.9% (79 ± 10 mmol/mol), and diabetes duration of 19 ± 9 years. Percentage of time with sensor glucose ≥250 mg/dL decreased with AID by 16.9% ± 16.2% (P < 0.0001), whereas percentage of time at <54 mg/dL remained low during both ST and AID (median interquartile range 0.0% 0.00%, 0.06% vs. 0.00% 0.00%, 0.03%; P = 0.4543). HbA1c (± SD) decreased by 1.3% ± 0.7% (14 ± 8 mmol/mol; P < 0.0001) and TIR increased by 21.9% ± 15.2% (P < 0.0001) without a significant change in total daily insulin or BMI with AID.
Findings from this feasibility trial of AID in adults with type 2 diabetes with suboptimal glycemic outcomes justify further evaluation of this technology in this population.
This study aims to assess the long-term outcomes of a modified pneumatic reduction protocol for intussusception at the Vietnam National Hospital of Pediatrics, an institution with a significant ...patient load in a lower-middle-income country.
A single center, retrospective cohort observational study was conducted to examine patients who underwent modified fluoroscopic-guided air-enema reduction (FGAR) for intussusception from January 2016 to December 2017. Data on patient demographics, complication rates, and the incidence of long-term recurrence was collected.
Between January 2016 and December 2017, a total of 3562 patients underwent modified FGAR at our institution, including 2313 males (64.9%) and 1249 females (35.1%). The median age was 19 months (range: 1–170), and the median FGAR procedure duration was 4 min (range: 2–24). The median hospital stay was 1 day (range: 1–31). Successful reduction was achieved in 98.7% of cases, with 43 unsuccessful cases and 4 cases of perforated bowel requiring surgery. Twenty patients, presenting with severe symptoms due to delayed treatment seeking, were admitted to the pediatric intensive care unit (ICU) post-FGAR. No mortality or severe morbidity was reported. Over a median 6-year follow-up, intussusception recurred in 198 patients, accounting for 5.6% of the cohort, with 97% of recurrences occurring within the first year post-reduction. Infants and children under 12 months of age had the highest complication rates, including failed FGAR, complicated intussusception, ICU admission, or recurrence, compared to other age groups, and this difference was statistically significant (p < 0.05).
The modified FGAR protocol has been demonstrated to be safe and feasible, with a very high success rate, low complication rate, and low recurrence rate. Although further comparative studies are needed to confirm its reproducibility, it should be considered a promising approach for children in low-to middle-income countries.
Level III.
•What is currently known about this topic?
Non-surgical techniques, such as fluoroscopy-guided air enema reduction (FGAR), are widely accepted in healthcare settings globally for managing intussusception, providing effective and minimally invasive alternatives to surgery.
However, intussusception continues to cause substantial morbidity in numerous low-to middle-income countries (LMICs), where some centers have not yet adopted these non-surgical approaches.•What new information is contained in this article?
Modified FGAR, even without a pressure gauge for accurate monitoring of intra-abdominal pressure, has proven to be safe and effective, with a complication rate of 0.11% and no reported mortality or severe morbidity.
The synchronized effect of applying air pressure internally and performing manual reduction maneuvers externally, under direct vision, contributed to the short duration (median = 4 min) and high success rate (98.7%) of modified FGAR.
Utilizing a self-assembled apparatus that is inexpensive, straightforward, and easy-to-operate, modified FGAR should be considered the first-line treatment for intussusception, especially in LMICs.
The objective of this study was to assess the safety and performance of the Omnipod
personalized model predictive control (MPC) algorithm in adults, adolescents, and children aged ≥6 years with type ...1 diabetes (T1D) under free-living conditions using an investigational device.
A 96-h hybrid closed-loop (HCL) study was conducted in a supervised hotel/rental home setting following a 7-day outpatient standard therapy (ST) phase. Eligible participants were aged 6-65 years with A1C <10.0% using insulin pump therapy or multiple daily injections. Meals during HCL were unrestricted, with boluses administered per usual routine. There was daily physical activity. The primary endpoints were percentage of time with sensor glucose <70 and ≥250 mg/dL.
Participants were 11 adults, 10 adolescents, and 15 children aged (mean ± standard deviation) 28.8 ± 7.9, 14.3 ± 1.3, and 9.9 ± 1.0 years, respectively. Percentage time ≥250 mg/dL during HCL was 4.5% ± 4.2%, 3.5% ± 5.0%, and 8.6% ± 8.8% per respective age group, a 1.6-, 3.4-, and 2.0-fold reduction compared to ST (
= 0.1,
= 0.02, and
= 0.03). Percentage time <70 mg/dL during HCL was 1.9% ± 1.3%, 2.5% ± 2.0%, and 2.2% ± 1.9%, a statistically significant decrease in adults when compared to ST (
= 0.005,
= 0.3, and
= 0.3). Percentage time 70-180 mg/dL increased during HCL compared to ST, reaching significance for adolescents and children: HCL 73.7% ± 7.5% vs. ST 68.0% ± 15.6% for adults (
= 0.08), HCL 79.0% ± 12.6% vs. ST 60.6% ± 13.4% for adolescents (
= 0.01), and HCL 69.2% ± 13.5% vs. ST 54.9% ± 12.9% for children (
= 0.003).
The Omnipod personalized MPC algorithm was safe and performed well over 5 days and 4 nights of use by a cohort of participants ranging from youth aged ≥6 years to adults with T1D under supervised free-living conditions with challenges, including daily physical activity and unrestricted meals.
The Omnipod 5 AID System is a novel tubeless hybrid closed-loop system approved for use in people with type 1 diabetes ages 2 and up and was recently evaluated in adults with type 2 diabetes (T2D) ...during an 8-week outpatient feasibility study. The System allows for personalized therapy through customizable glucose targets from 110-150mg/dL in 10mg/dL increments and enables automatic upload of data for all users, facilitating unprecedented access to evaluate real-world outcomes. Continuous glucose monitoring (CGM) and insulin data from Omnipod 5 users with T2D aged ≥18y in the US with ≥90 days of data available in the cloud-based data management system were included. Data from 417 users with sufficient CGM data (≥75% of days with ≥220 readings) and using the lowest target (110mg/dL) for ≥50% of the time, aged 18 to 49y (n=108), 50 to 64y (n=156), and ≥65y (n=153), were available at the time of analysis. Users were aged mean±SD 57.9±12.8y with median 131 days of system use. Outcomes are shown in the Table. Median time in target range (70-180mg/dL) was 68.7%, 71.7%, and 74.0% for each age group, respectively. Time spent in hypoglycemia (<70mg/dL) was low (median 0.3%) in each age group. These data are the first to provide valuable insights to the highly favorable impact of AID on real-world glycemic outcomes among adults with T2D using the Omnipod 5 System.
Disclosure
A.L.Peters: Advisory Panel; Abbott Diabetes, Medscape, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Stock/Shareholder; Omada Health, Inc., Livongo. F.J.Pasquel: Consultant; Dexcom, Inc., Medscape, Research Support; Dexcom, Inc., Ideal Medical Technologies. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. K.Snow: Employee; Insulet Corporation. J.J.Mendez: None. I.Hadjiyianni: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation, Eli Lilly and Company. T.T.Ly: Employee; Insulet Corporation.
Funding
Insulet Corporation
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