730-P: At-Home Randomized Crossover Comparison of Automated Insulin Delivery vs. Conventional Therapy with Scheduled Meal Challenges

BACKGROUND Exergames are increasingly used among stroke survivors with chronic UE sequelae, to continue exercising at home, after discharge, and maintain activity level. The use of virtual reality exergames combined with telerehabilitation app (VirTele) may be an interesting alternative to rehabilitate the UE sequelae in chronic stroke survivors while allowing for ongoing monitoring with a clinician. OBJECTIVE 1) To determine the feasibility of using VirTele with chronic stroke survivors at home; 2) To explore the impact of VirTele on UE motor function, quantity and quality of use, quality of life, and motivation, in chronic stroke survivors, compared with conventional therapy (GRASP: Graded Repetitive Arm Supplementary Program). METHODS This is a feasibility clinical trial including a two-arm trial design. Eligible participants were randomly allocated to an experimental group (receiving VirTele for 8 weeks) or a control group (receiving conventional therapy for 8 weeks). Feasibility measurements included the number and active time spent on exergame sessions, frequency and time spent by the clinician during videoconferencing sessions, satisfaction with the technology, and resource utilization (equipment, technical support). Outcome measurements included the Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Motor Activity log-30 (MAL), Stroke Impact Scale-16 (SIS), and Treatment Self-Regulation Questionnaire-15 (TSRQ) and were administered to both groups at four-time points: T1: before starting the intervention; T2: post-intervention; T3: one-month post-intervention and T4: two-months post-intervention. RESULTS A total of 11 stroke survivors were randomized and allocated to the treatment group. At the COVID-19 onset, participants pursued the allocated treatment for 3-months. VirTele intervention dose was captured in term of time spent on exergames (mean-8 weeks: 16.6 hours; SD 3.0 and mean-third month: 9.3 hours; SD 7.1), frequency of use of exergames (total-mean: 62,5; range: 49-84 sessions), and total number of successful repetitions (mean-8weeks: 13 683; SD 2367 and mean-third month:12035,5; SD 9508,46) and frequency of video-conference- sessions (total mean: 6,6 , range: 3-11 sessions). The technical issues included loss of passwords, Internet issues, updates of the system, and problems with the avatar. Overall, most stroke survivors found the technology easy to use and quite useful, except for one participant. For the FMA-UE and MAL, both groups exhibited an improvement in more than 50% of the participants, maintained over time. Regarding the SIS scores, the control group reported improvement in activities of daily life (60% (3/5)), hand function (100% (5/5)), and mobility (40% (2/5)), while the experimental group reported varied and non-conclusive results. For the TSRQ, 75% (3/4) of the experimental group demonstrated an increase in the autonomous motivation score, while in the control group this improvement was shown in only one participant. CONCLUSIONS VirTele intervention constitutes another therapeutic alternative, in addition to the conventional therapy to deliver an intense personalized rehabilitation program in chronic stroke survivors with UE sequelae. CLINICALTRIAL ClinicalTrials.gov NCT03759106; http://clinicaltrials.gov/show/NCT03759106. INTERNATIONAL REGISTERED REPORT RR2-10.2196/14629

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Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Children With Type 1 Diabetes (T1D)

Journal of the Endocrine Society ◽

10.1210/jendso/bvab048.927 ◽

2021 ◽

Vol 5 (Supplement_1) ◽

pp. A454-A454

Author(s):

Bruce A Buckingham ◽

Gregory P Forlenza ◽

Amy B Criego ◽

David W Hansen ◽

Bruce W Bode ◽

...

Keyword(s):

Insulin Pump ◽

Safety Evaluation ◽

Insulin Delivery ◽

Time Of Day ◽

Large Cohort ◽

Extension Phase ◽

Target Range ◽

Pivotal Study ◽

Glucose Management ◽

At Home

Abstract Advances in diabetes technology have transformed the treatment paradigm for T1D, yet the burden of the disease remains significant. The pediatric population poses unique challenges to glucose management with unpredictable exercise and food consumption. The Omnipod 5 System is a novel hybrid closed-loop (HCL) system with fully on-body operation. A tubeless insulin pump (pod) containing a personalized Model Predictive Control algorithm communicates directly with a Dexcom G6 continuous glucose monitor (CGM, or sensor) to automate insulin delivery. Therapy customization is enabled through glucose targets from 110–150 mg/dL, adjustable by time of day, which is a critical component to individualize glucose management in children. We report on the first, pivotal outpatient safety evaluation of the Omnipod 5 System in a large cohort of children with T1D. Participants aged 6–13.9y with T1D≥6 months and A1C<10% used the HCL system for 3 months at home after a 14-day run-in phase of their standard therapy (ST, included both pump therapy and multiple daily injections). The primary safety and effectiveness endpoints, respectively, were occurrence of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA), and change in A1C and sensor glucose percent time in target range (TIR) (70–180 mg/dL) during HCL compared with ST. Participants (N=112) were aged (mean±SD) 10.3±2.2y with T1D duration 4.7±2.6y and baseline A1C 7.7±0.9% (range 5.8–10.3%). TIR increased significantly from ST to HCL, from 52.5±15.6% to 68.0±8.1% (p<0.0001), corresponding to an additional 3.7 hours/day in target range. A1C at end of study was reduced by 0.7% to 7.0±0.6% (p<0.0001). Percentages of time in hyperglycemia were reduced: >180 mg/dL from 45.3±16.7% to 30.2±8.7% and ≥250 mg/dL from 19.1±13.1% to 9.6±5.4% (both p<0.0001). Percentages of time in hypoglycemia remained low from ST to HCL: <54 mg/dL from 0.4±0.8% to 0.3±0.3% and <70 mg/dL from 2.2±2.7% to 1.8±1.4% (both p>0.05). Mean glucose decreased from 183±32 to 160±15 mg/dL (p<0.0001). During the HCL phase there was 1 episode of SH (delayed eating after pre-meal bolus) and 1 episode of DKA (suspected infusion site failure) reported. Virtually all participants completing the pivotal study (99%) continued system use during an extension phase. In this multi-center pivotal study in a large cohort of children with T1D, the Omnipod 5 System was safe and effective when used for 3 months at home. There were significant improvements in both TIR and A1C, while time below range (<70 mg/dL) remained low. The beneficial glycemic outcomes are critical for children, given that neurologic outcomes can be negatively impacted by hyperglycemia. The current results and commitment to the extension phase emphasize the safe and effective use of the HCL system, as well as the preference for the Omnipod 5 System over participants’ previous therapy.

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Siblings of Children with Mental Retardation Living at Home or in Residential Placement

Journal of Child Psychology and Psychiatry ◽

10.1017/s0021963097002084 ◽

1998 ◽

Vol 39 (3) ◽

pp. 355-363 ◽

Cited By ~ 36

Author(s):

Laurie Eisenberg ◽

Bruce L. Baker ◽

Jan Blacher

Keyword(s):

Mental Retardation ◽

Residential Placement ◽

At Home

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Systematic Modification of Parental Input to Train Language Symbols

Language Speech and Hearing Services in Schools ◽

10.1044/0161-1461.1201.04 ◽

1981 ◽

Vol 12 (1) ◽

pp. 4-12 ◽

Cited By ~ 6

Author(s):

Barbara Culatta ◽

Donna Horn

Keyword(s):

Language Learning ◽

Meaningful Use ◽

Hearing Impaired ◽

Specific Language ◽

Parental Input ◽

Language Exposure ◽

Therapy Sessions ◽

Impaired Children ◽

Hearing Impaired Children ◽

At Home

This study attempted to maximize environmental language learning for four hearing-impaired children. The children's mothers were systematically trained to present specific language symbols to their children at home. An increase in meaningful use of these words was observed during therapy sessions. In addition, as the mothers began to generalize the language exposure strategies, an increase was observed in the children's use of words not specifically identified by the clinician as targets.

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Iterative Development of a Home Review Program to Promote Preschoolers' Vocabulary Skills: Social Validity and Learning Outcomes

Language Speech and Hearing Services in Schools ◽

10.1044/2019_lshss-19-00011 ◽

2020 ◽

Vol 51 (2) ◽

pp. 371-389 ◽

Cited By ~ 2

Author(s):

Xigrid Soto ◽

Yagmur Seven ◽

Meaghan McKenna ◽

Keri Madsen ◽

Lindsey Peters-Sanders ◽

...

Keyword(s):

High Stress ◽

Social Validity ◽

Home Language ◽

Single Subject ◽

Considerable Difficulty ◽

Home Program ◽

Iterative Development ◽

Vocabulary Skills ◽

Validity Measures ◽

At Home

Purpose This article describes the iterative development of a home review program designed to augment vocabulary instruction for young children (ages 4 and 5 years) occurring at school through the use of a home review component. Method A pilot study followed by two experiments used adapted alternating treatment designs to compare the learning of academic words taught at school to words taught at school and reviewed at home. At school, children in small groups were taught academic words embedded in prerecorded storybooks for 6 weeks. Children were given materials such as stickers with review prompts (e.g., “Tell me what brave means”) to take home for half the words. Across iterations of the home intervention, the home review component was enhanced by promoting parent engagement and buy-in through in-person training, video modeling, and daily text message reminders. Visual analyses of single-subject graphs, multilevel modeling, and social validity measures were used to evaluate the additive effects and feasibility of the home review component. Results Social validity results informed each iteration of the home program. The effects of the home program across sites were mixed, with only one site showing consistently strong effects. Superior learning was evident in the school + home review condition for families that reviewed words frequently at home. Although the home review program was effective in improving the vocabulary skills of many children, some families had considerable difficulty practicing vocabulary words. Conclusion These studies highlight the importance of using social validity measures to inform iterative development of home interventions that promote feasible strategies for enhancing the home language environment. Further research is needed to identify strategies that stimulate facilitators and overcome barriers to implementation, especially in high-stress homes, to enrich the home language environments of more families.

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