This study evaluated a new insulin delivery system designed to reduce insulin delivery when trends in continuous glucose monitoring (CGM) glucose concentrations predict future hypoglycemia.
...Individuals with type 1 diabetes (
= 103, age 6-72 years, mean HbA
7.3% 56 mmol/mol) participated in a 6-week randomized crossover trial to evaluate the efficacy and safety of a Tandem Diabetes Care t:slim X2 pump with Basal-IQ integrated with a Dexcom G5 sensor and a predictive low-glucose suspend algorithm (PLGS) compared with sensor-augmented pump (SAP) therapy. The primary outcome was CGM-measured time <70 mg/dL.
Both study periods were completed by 99% of participants; median CGM usage exceeded 90% in both arms. Median time <70 mg/dL was reduced from 3.6% at baseline to 2.6% during the 3-week period in the PLGS arm compared with 3.2% in the SAP arm (difference PLGS - SAP = -0.8%, 95% CI -1.1 to -0.5,
< 0.001). The corresponding mean values were 4.4%, 3.1%, and 4.5%, respectively, represent-ing a 31% reduction in the time <70 mg/dL with PLGS. There was no increase in mean glucose concentration (159 vs. 159 mg/dL,
= 0.40) or percentage of time spent >180 mg/dL (32% vs. 33%,
= 0.12). One severe hypoglycemic event occurred in the SAP arm and none in the PLGS arm. Mean pump suspension time was 104 min/day.
The Tandem Diabetes Care Basal-IQ PLGS system significantly reduced hypoglycemia without rebound hyperglycemia, indicating that the system can benefit adults and youth with type 1 diabetes in improving glycemic control.
Young mouse plasma restores memory in aged mice, but, to our knowledge, the effects are unknown in patients with Alzheimer disease (AD).
To assess the safety, tolerability, and feasibility of ...infusions of young fresh frozen plasma (yFFP) from donors age 18 to 30 years in patients with AD.
The Plasma for Alzheimer Symptom Amelioration (PLASMA) study randomized 9 patients under a double-blind crossover protocol to receive 4 once-weekly infusions of either 1 unit (approximately 250 mL) of yFFP from male donors or 250 mL of saline, followed by a 6-week washout and crossover to 4 once-weekly infusions of an alternate treatment. Patients and informants were masked to treatment and subjective measurements. After an open-label amendment, 9 patients received 4 weekly yFFP infusions only and their subjective measurements were unmasked. Patients were enrolled solely at Stanford University, a tertiary academic medical center, from September 2014 to December 2016, when enrollment reached its target. Eighteen consecutive patients with probable mild to moderate AD dementia, a Mini-Mental State Examination (score of 12 to 24 inclusive), and an age of 50 to 90 years were enrolled. Thirty-one patients were screened and 13 were excluded: 11 failed the inclusion criteria and 2 declined to participate.
One unit of yFFP from male donors/placebo infused once weekly for 4 weeks.
The primary outcomes were the safety, tolerability, and feasibility of 4 weekly yFFP infusions. Safety end point analyses included all patients who received the study drug/placebo.
There was no difference in the age (mean SD, 74.17 7.96 years), sex (12 women 67%), or baseline Mini-Mental State Examination score (mean SD, 19.39 3.24) between the crossover (n = 9) and open-label groups (n = 9). There were no related serious adverse events. One patient discontinued participation because of urticaria and another because of an unrelated stroke. There was no statistically significant difference between the plasma (17 94.4%) and placebo (9 100.0%) cohorts for other adverse events, which were mild to moderate in severity. The most common adverse events in the plasma group included hypertension (3 16.7%), dizziness (2 11.1%), sinus bradycardia (3 16.7%), headache (3 16.7%), and sinus tachycardia (3 16.7%). The mean visit adherence (n = 18) was 86% (interquartile range, 87%-100%) and adherence, accounting for a reduction in the total visit requirement due to early patient discontinuation, was 96% (interquartile range, 89%-100%).
The yFFP treatment was safe, well tolerated, and feasible. The study's limitations were the small sample size, short duration, and change in study design. The results warrant further exploration in larger, double-blinded placebo-controlled clinical trials.
ClinicalTrials.gov Identifier: NCT02256306.
This was a randomized double blinded study of a novel infusion set with and without heparin, hypothesizing that small doses of heparin would decrease thrombosis and subcutaneous inflammation.
The ...MiniMed™ Quick-set™ infusion set was modified with a new tubing connector from current P-Cap. The P-Cap was modified to contain a foam (F) or a foam with heparin (F+H) connector. Visibly the sets appeared identical. Each participant wore two F and two F + H sets for 7 days or until set failure. The order of infusion set wear was randomly assigned. Infusion set failure was determined by unexplained hyperglycemia >250mg/dL with a failed correction dose, ketones >0.6mmol/L, evidence of infection, occlusion alarms, or adhesive failure. Infused set survival was compared to similar published 1-week studies using standard Quick-sets.
There were 20 participants (mean age 29.5±8 years). Each set was worn 40 times. Length of wear and causes of failure are shown below. Length of wear was not different between the F and F+H groups, but both had improved length of wear compared to historical Quick-sets (p<0.05). There was no significant increase in insulin requirements or mean glucose values throughout the seven days of wear in any group.
There was no difference in overall duration of wear between the F and F+H groups. Both infusion set groups intended for extended wear had significantly better survival than the historical Quick-Set™ group. Further studies are planned with the F group.
Disclosure
B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Medtronic. Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. T. Marcal: None. L. Hoffman: None. G. Musolino: None. L. Ekhlaspour: None. G. Zhang: None. S. Chattaraj: Employee; Self; Medtronic.
Funding
Medtronic Diabetes
As artificial pancreas (AP) becomes standard of care, consideration of extended use of insulin infusion sets (IIS) and continuous glucose monitors (CGMs) becomes vital. We conducted an outpatient ...randomized crossover study to test the safety and efficacy of a zone model predictive control (zone-MPC)-based AP system versus sensor augmented pump (SAP) therapy in which IIS and CGM failures were provoked via extended wear to 7 and 21 days, respectively.
A smartphone-based AP system was used by 19 adults (median age 23 years IQR 10, mean 8.0 ± 1.7% HbA
) over 2 weeks and compared with SAP therapy for 2 weeks in a crossover, unblinded outpatient study with remote monitoring in both study arms.
AP improved percent time 70-140 mg/dL (48.1 vs. 39.2%;
= 0.016) and time 70-180 mg/dL (71.6 vs. 65.2%;
= 0.008) and decreased median glucose (141 vs. 153 mg/dL;
= 0.036) and glycemic variability (SD 52 vs. 55 mg/dL;
= 0.044) while decreasing percent time <70 mg/dL (1.3 vs. 2.7%;
= 0.001). AP also improved overnight control, as measured by mean glucose at 0600 h (140 vs. 158 mg/dL;
= 0.02). IIS failures (1.26 ± 1.44 vs. 0.78 ± 0.78 events;
= 0.13) and sensor failures (0.84 ± 0.6 vs. 1.1 ± 0.73 events;
= 0.25) were similar between AP and SAP arms. Higher percent time in closed loop was associated with better glycemic outcomes.
Zone-MPC significantly and safely improved glycemic control in a home-use environment despite prolonged CGM and IIS wear. This project represents the first home-use AP study attempting to provoke and detect component failure while successfully maintaining safety and effective glucose control.
Background: Our research study group recently evaluated a PLGS system embedded on the Tandem t:slim X2 with Basal-IQ insulin pump. The system was designed to work "in the background" without alarms ...when suspending and restarting insulin delivery. System usability and effectiveness in decreasing hypoglycemia are both critical to the success of a PLGS device.
Methods: The PROLOG study was a randomized crossover trial conducted at 4 U.S. sites. Participants with type 1 diabetes (age ≥6 years, n=102) previously treated with MDI or CSII (with and without CGM) were randomized to the order of treatment: PLGS during one 3-week period and sensor-augmented pump (SAP) during the alternate 3-week period. We recently reported the primary outcome of the PROLOG study-a reduction of mean sensor time <70 mg/dL by 31% relative to SAP. In addition to glycemic outcomes, usability of the system was evaluated using a validated measure, the System Usability Scale (SUS).
Results: The overall SUS score for at-home use of the Basal-IQ system was 88.8 (out of 100). A score above 68 is considered above average, and 88 is exceptional. Subgroup analyses revealed no differences related to age, baseline glycemic control or baseline diabetes therapy (MDI, CGM or pump use, Table 1).
Conclusions: The t:slim X2 with Basal-IQ was safe, effective, and easy for participants to use, regardless of previous experience with diabetes technology.
Disclosure
J.E. Pinsker: Research Support; Self; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. Z. Li: None. B.A. Buckingham: Advisory Panel; Self; Novo Nordisk Inc., ConvaTec Inc.. Research Support; Self; Medtronic, Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. Consultant; Self; Tandem Diabetes Care, Inc., Becton, Dickinson and Company. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc.. Research Support; Self; Medtronic, Tandem Diabetes Care, Inc., Insulet Corporation, Dexcom, Inc., Novo Nordisk Inc., Bigfoot Biomedical. E. Cengiz: Advisory Panel; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; MannKind Corporation, ADOCIA, Arecor. M. Church: None. L. Ekhlaspour: None. R. Wadwa: Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; MannKind Corporation, Dexcom, Inc., Xeris Pharmaceuticals, Inc., Bigfoot Biomedical. S.A. Weinzimer: Speaker's Bureau; Self; Medtronic MiniMed, Inc., Insulet Corporation. Consultant; Self; Sanofi. Stock/Shareholder; Self; InsuLine Medical Ltd.. C.C. Andre: None. T. Marcal: None. E. Jost: Other Relationship; Self; Medtronic MiniMed, Inc.. L.R. Carria: None. W.J. Woodall: None. B. Dokken: Employee; Self; Tandem Diabetes Care, Inc. V. Swanson: Employee; Self; Tandem Diabetes Care, Inc. J.W. Lum: Other Relationship; Self; Bigfoot Biomedical, Tandem Diabetes Care, Inc., Eli Lilly and Company, Ascensia Diabetes Care. C. Kollman: Research Support; Self; JDRF, Bigfoot Biomedical, Dexcom, Inc., Tandem Diabetes Care, Inc., Medtronic MiniMed, Inc., Helmsley Charitable Trust. R.W. Beck: Consultant; Self; Eli Lilly and Company. Research Support; Self; Abbott. Consultant; Self; Bigfoot Biomedical. Research Support; Self; Dexcom, Inc.. Consultant; Self; Insulet Corporation. Research Support; Self; Roche Diabetes Care Health and Digital Solutions. Consultant; Self; Merck & Co., Inc., Xeris Pharmaceuticals, Inc..
Background:
As evidence emerges that artificial pancreas systems improve clinical outcomes for patients with type 1 diabetes, the burden of this disease will hopefully begin to be alleviated for many ...patients and caregivers. However, reliance on automated insulin delivery potentially means patients will be slower to act when devices stop functioning appropriately. One such scenario involves an insulin infusion site failure, where the insulin that is recorded as delivered fails to affect the patient’s glucose as expected. Alerting patients to these events in real time would potentially reduce hyperglycemia and ketosis associated with infusion site failures.
Methods:
An infusion site failure detection algorithm was deployed in a randomized crossover study with artificial pancreas and sensor-augmented pump arms in an outpatient setting. Each arm lasted two weeks. Nineteen participants wore infusion sets for up to 7 days. Clinicians contacted patients to confirm infusion site failures detected by the algorithm and instructed on set replacement if failure was confirmed.
Results:
In real time and under zone model predictive control, the infusion site failure detection algorithm achieved a sensitivity of 88.0% (n = 25) while issuing only 0.22 false positives per day, compared with a sensitivity of 73.3% (n = 15) and 0.27 false positives per day in the SAP arm (as indicated by retrospective analysis). No association between intervention strategy and duration of infusion sets was observed (P = .58).
Conclusions:
As patient burden is reduced by each generation of advanced diabetes technology, fault detection algorithms will help ensure that patients are alerted when they need to manually intervene.
Clinical Trial Identifier:
www.clinicaltrials.gov,NCT02773875
São cada vez mais os jovens a ingressar no ensino superior e importa reconhecer a especificidade em cada um deles. Os jovens com deficiência desejam entrar no ensino superior pela oportunidade de ...crescimento pessoal e social que esse facto simboliza. Assim, o presente trabalho propõe-se explorar a questão da inclusão no ensino superior de pessoas com deficiência. Este projeto é composto por uma dimensão teórica, na qual são exploradas as questões da deficiência e da inclusão no ensino, e, por uma dimensão de investigação empírica, em que se procurou construir retratos de estudantes com deficiência no ensino superior, baseados nas suas personalidades e histórias de vida, os quais serão apresentados e analisados no presente trabalho.
ABSTRACT
The observation of Near Earth objects (NEOs) allows us to study the physical properties of the smallest size bodies of our Solar System and help impose constraints on their origin and ...evolution. The solar phase curve is a very important tool to derive diverse physical properties of a small body so that we set up an observational campaign to derive the phase curve parameters (H, G1, G2) for a large number of NEOs. We present here the obtained phase curves for 12 NEOs, along with the rotation period for two of them and the V–R colour for four. The data was acquired mainly at the Astronomical Observatory of Sertão de Itaparica (Brazil), with some NEOs also observed at the Osservatorio di Campo Imperatore (Italy). Considering all the objects observed throughout our campaign we analysed a homogeneous dataset of 30 NEOs along with data acquired by ATLAS (Asteroid Terrestrial-impact Last Alert System telescopes survey) for MB asteroids. The behavior in the phase space G1-G2 of 21,865 MBA and 103 NEOs was analysed, separating the objects in intervals of albedos and sizes. From the large MB data set we found evidence that the distribution in the G1-G2 phase space has strong dependence not only on the albedo but also on the object’s size. This is particularly true for the smaller objects. The main result being that, on the contrary to what occurs with the MB larger objects, we are unable to estimate the albedo of a NEO from its phase curve parameters.
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