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2.
J Diabetes Sci Technol ; : 1932296820906214, 2020 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-32172603

RESUMO

BACKGROUND: We determined the uptake rate of continuous glucose monitors (CGMs) and examined associations of clinical and demographic characteristics with CGM use among patients with type 1 diabetes covered by Colorado Medicaid during the first two years of CGM coverage with no out-of-pocket cost. METHOD: We retrospectively reviewed data from 892 patients with type 1 diabetes insured by Colorado Medicaid (Colorado Health Program [CHP] and CHP+, Colorado Medicaid expansion). Demographics, insulin pump usage, CGM usage, and hemoglobin A1c (A1c) were extracted from the medical record. Data downloaded into CGM software at clinic appointments were reviewed to determine 30-day use prior to appointments. Subjects with some exposure to CGM were compared to subjects never exposed to CGM, and we examined the effect of CGM use on glycemic control. RESULTS: Twenty percent of subjects had some exposure to CGM with a median of 22 [interquartile range 8, 29] days wear. Sixty one percent of CGM users had >85% sensor wear. Subjects using CGM were more likely to be younger (P < .001), have shorter diabetes duration (P < .001), and be non-Hispanic White (P < .001) than nonusers. After adjusting for age and diabetes duration, combined pump and CGM users had a lower A1c than those using neither technology (P = .006). Lower A1c was associated with greater CGM use (P = .002) and increased percent time in range (P < .001). CONCLUSION: Pediatric Medicaid patients successfully utilized CGM. Expansion of Medicaid coverage for CGM may help improve glycemic control and lessen disparities in clinical outcomes within this population.

3.
Artigo em Inglês | MEDLINE | ID: mdl-32105513

RESUMO

Background: Pediatric patients undergoing hematopoietic stem cell transplantation (HSCT) may be at risk for malglycemia and adverse outcomes, including infection, prolonged hospital stays, organ dysfunction, graft-versus-host-disease, delayed hematopoietic recovery, and increased mortality. Continuous glucose monitoring (CGM) may aid in describing and treating malglycemia in this population. However, no studies have demonstrated safety, tolerability, or accuracy of CGM in this uniquely immunocompromised population. Materials and Methods: A prospective observational study was conducted, using the Abbott Freestyle Libre Pro, in patients aged 2-30 undergoing HSCT at Children's Hospital Colorado to evaluate continuous glycemia in this population. CGM occurred up to 7 days before and 60 days after HSCT, during hospitalization only. In a secondary analysis of this data, blood glucoses collected during routine HSCT care were compared with CGM values to evaluate accuracy. Adverse events and patient refusal to wear CGM device were monitored to assess safety and tolerability. Results: Participants (n = 29; median age 13.1 years, [interquartile range] [4.7, 16.6] years) wore 84 sensors for an average of 25 [21.5, 30.0] days per participant. Paired serum-sensor values (n = 893) demonstrated a mean absolute relative difference of 20% ± 14% with Clarke Error Grid analysis showing 99% of pairs in the clinically acceptable Zones (A+B). There were four episodes of self-limited bleeding (4.8% of sensors); no other adverse events occurred. Six patients (20.7%) refused subsequent CGM placements. Conclusions: CGM use appears safe and feasible although with suboptimal accuracy in the hospitalized pediatric HSCT population. Few adverse events occurred, all of which were low grade.

5.
Diabetes Care ; 43(3): 607-615, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31937608

RESUMO

OBJECTIVE: Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND METHODS: This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L. RESULTS: Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n = 65) versus SAP (n = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7% [95% CI -2.4, -1.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference -3.0% [95% CI -6.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device. CONCLUSIONS: In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.

6.
Diabetes Technol Ther ; 22(3): 174-184, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31596130

RESUMO

Background: 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. Materials and Methods: 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. Results: 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 (P = 0.1, P = 0.02, and P = 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 (P = 0.005, P = 0.3, and P = 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 (P = 0.08), HCL 79.0% ± 12.6% vs. ST 60.6% ± 13.4% for adolescents (P = 0.01), and HCL 69.2% ± 13.5% vs. ST 54.9% ± 12.9% for children (P = 0.003). Conclusions: 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.

7.
Pediatr Diabetes ; 21(2): 310-318, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31837064

RESUMO

OBJECTIVE: To describe glycemic and psychosocial outcomes in youth with type 1 diabetes using a hybrid closed loop (HCL) system. SUBJECTS: Youth with type 1 diabetes (2-25 years) starting the 670G HCL system for their diabetes care were enrolled in an observational study. METHODS: Prospective data collection occurred during routine clinical care and included glycemic variables (sensor time in range [70-180 mg/dL], HbA1c), and psychosocial variables (Hypoglycemia Fear Survey [HFS]; Problem Areas in Diabetes [PAID]). Mixed models were used to analyze change across time. RESULTS: Ninety-two youth (mean age 15.7 ± 3.6 years, 50% female, HbA1c 8.8% ± 1.8%) started HCL for their diabetes care. Youth used Auto Mode 65.5% ± 3.0% of the time at month 1, which decreased to 51.2% ± 3.4% at month 6 (P = .001). Sensor time in range increased from 50.7% ± 1.8% at baseline to 56.9% ± 2.1% at 6 months (P = .007). HbA1c decreased from 8.7% ± 0.2% at baseline to 8.4% ± 0.2% after 6 months of use (P ≤ .0001), with the greatest HbA1c decline in participants with high baseline HbA1c. Increased percent time in auto mode was associated with lower HbA1c (P = .02). Thirty percent of youth discontinued HCL in the first 6 months of use. There were no changes in the HFS or PAID scores across time. CONCLUSIONS: HCL use is associated with improved glycemic control and no change in psychosocial outcomes in this clinical sample. The decline in HCL use across time suggests that youth experience barriers in sustaining use of HCL. Further research is needed to understand reasons for HCL discontinuation and determine intervention strategies.

8.
Pediatr Diabetes ; 21(2): 319-327, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31885123

RESUMO

OBJECTIVE: To describe predictors of hybrid closed loop (HCL) discontinuation and perceived barriers to use in youth with type 1 diabetes. SUBJECTS: Youth with type 1 diabetes (eligible age 2-25 y; recruited age 8-25 y) who initiated the Minimed 670G HCL system were followed prospectively for 6 mo in an observational study. RESEARCH DESIGN AND METHODS: Demographic, glycemic (time-in-range, HbA1c), and psychosocial variables [Hypoglycemia Fear Survey (HFS); Problem Areas in Diabetes (PAID)] were collected for all participants. Participants who discontinued HCL (<10% HCL use at clinical visit) completed a questionnaire on perceived barriers to HCL use. RESULTS: Ninety-two youth (15.7 ± 3.6 y, HbA1c 8.8 ± 1.3%, 50% female) initiated HCL, and 28 (30%) discontinued HCL, with the majority (64%) discontinuing between 3 and 6 mo after HCL start. Baseline HbA1c predicted discontinuation (P = .026) with the odds of discontinuing 2.7 times higher (95% CI: 1.123, 6.283) for each 1% increase in baseline HbA1c. Youth who discontinued HCL rated difficulty with calibrations, number of alarms, and too much time needed to make the system work as the most problematic aspects of HCL. Qualitatively derived themes included technological difficulties (error alerts, not working correctly), too much work (calibrations, fingersticks), alarms, disappointment in glycemic control, and expense (cited by parents). CONCLUSIONS: Youth with higher HbA1c are at greater risk for discontinuing HCL than youth with lower HbA1c, and should be the target of new interventions to support device use. The primary reasons for discontinuing HCL relate to the workload required to use HCL.

9.
N Engl J Med ; 381(18): 1707-1717, 2019 10 31.
Artigo em Inglês | MEDLINE | ID: mdl-31618560

RESUMO

BACKGROUND: Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes. METHODS: In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring. RESULTS: A total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (±SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61±17% at baseline to 71±12% during the 6 months and remained unchanged at 59±14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval [CI], 9 to 14; P<0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was >180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was <70 mg per deciliter or <54 mg per deciliter [3.0 mmol per liter]) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was -0.88 percentage points (95% CI, -1.19 to -0.57; P<0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was -0.33 percentage points (95% CI, -0.53 to -0.13; P = 0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group. CONCLUSIONS: In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.).


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Pâncreas Artificial , Adolescente , Adulto , Idoso , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Desenho de Equipamento , Feminino , Hemoglobina A Glicada/análise , Humanos , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Sistemas de Infusão de Insulina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Pâncreas Artificial/efeitos adversos , Adulto Jovem
10.
Expert Rev Med Devices ; 16(10): 845-853, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31540557

RESUMO

Introduction: Automated insulin delivery for people with type 1 diabetes has been a major goal in the diabetes technology field for many years. While a fully automated system has not yet been accomplished, the MiniMed™ 670G artificial pancreas (AP) system is the first commercially available insulin pump that automates basal insulin delivery, while still requiring user input for insulin boluses. Determining the safety and efficacy of this system is essential to the development of future devices striving for more automation. Areas Covered: This review will provide an overview of how the MiniMed 670G system works including its safety and efficacy, how it compares to similar devices, and anticipated future advances in diabetes technology currently under development. Expert Opinion: The ultimate goal of advanced diabetes technologies is to reduce the burden and amount of management required of patients with diabetes. In addition to reducing patient workload, achieving better glucose control and improving hemoglobin A1c (HbA1c) values are essential for reducing the threat of diabetes-related complications further down the road. Current devices come close to reaching these goals, but understanding the unmet needs of patients with diabetes will allow future technologies to achieve these goals more quickly.


Assuntos
Diabetes Mellitus Tipo 1/terapia , Pâncreas Artificial/efeitos adversos , Humanos , Sistemas de Infusão de Insulina , Vigilância de Produtos Comercializados , Resultado do Tratamento
11.
Diabetes Spectr ; 32(3): 194-204, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31462873

RESUMO

IN BRIEF Insulin pump therapy is advancing rapidly. This article summarizes the variety of insulin pump technologies available to date and discusses important clinical considerations for each type of technology.

14.
Pediatr Diabetes ; 20(6): 759-768, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31099946

RESUMO

OBJECTIVE: Artificial pancreas (AP) systems have been shown to improve glycemic control throughout the day and night in adults, adolescents, and children. However, AP testing remains limited during intense and prolonged exercise in adolescents and children. We present the performance of the Tandem Control-IQ AP system in adolescents and children during a winter ski camp study, where high altitude, low temperature, prolonged intense activity, and stress challenged glycemic control. METHODS: In a randomized controlled trial, 24 adolescents (ages 13-18 years) and 24 school-aged children (6-12 years) with Type 1 diabetes (T1D) participated in a 48 hours ski camp (∼5 hours skiing/day) at three sites: Wintergreen, VA; Kirkwood, and Breckenridge, CO. Study participants were randomized 1:1 at each site. The control group used remote monitored sensor-augmented pump (RM-SAP), and the experimental group used the t: slim X2 with Control-IQ Technology AP system. All subjects were remotely monitored 24 hours per day by study staff. RESULTS: The Control-IQ system improved percent time within range (70-180 mg/dL) over the entire camp duration: 66.4 ± 16.4 vs 53.9 ± 24.8%; P = .01 in both children and adolescents. The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023. There were no differences between groups for hypoglycemia exposure or carbohydrate interventions. There were no adverse events. CONCLUSIONS: The use of the Control-IQ AP improved glycemic control and safely reduced exposure to hyperglycemia relative to RM-SAP in pediatric patients with T1D during prolonged intensive winter sport activities.

15.
Diabetes Technol Ther ; 21(4): 159-169, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30888835

RESUMO

OBJECTIVE: Hybrid closed-loop (HCL) artificial pancreas (AP) systems are now moving from research settings to widespread clinical use. In this study, the inControl algorithm developed by TypeZero Technologies was embedded to a commercial Tandem t:slim X2 insulin pump, now called Control-IQ, paired with a Dexcom G6 continuous glucose monitor and tested for superiority against sensor augmented pump (SAP) therapy. Both groups were physician-monitored throughout the clinical trial. RESEARCH DESIGN AND METHODS: In a randomized controlled trial, 24 school-aged children (6-12 years) with type 1 diabetes (T1D) participated in a 3-day home-use trial at two sites: Stanford University and the Barbara Davis Center (50% girls, 9.6 ± 1.9 years of age, 4.5 ± 1.9 years of T1D, baseline hemoglobin A1c 7.35% ± 0.68%). Study subjects were randomized 1:1 at each site to either HCL AP therapy with the Control-IQ system or SAP therapy with remote monitoring. RESULTS: The primary outcome, time in target range 70-180 mg/dL, using Control-IQ significantly improved (71.0% ± 6.6% vs. 52.8% ± 13.5%; P = 0.001) and mean sensor glucose (153.6 ± 13.5 vs. 180.2 ± 23.1 mg/dL; P = 0.003) without increasing hypoglycemia time <70 mg/dL (1.7% [1.3%-2.1%] vs. 0.9% [0.3%-2.7%]; not significant). The HCL system was active for 94.4% of the study period. Subjects reported that use of the system was associated with less time thinking about diabetes, decreased worry about blood sugars, and decreased burden in managing diabetes. CONCLUSIONS: The use of the Tandem t:slim X2 with Control-IQ HCL AP system significantly improved time in range and mean glycemic control without increasing hypoglycemia in school-aged children with T1D during remote monitored home use.


Assuntos
Automonitorização da Glicemia , Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Pâncreas Artificial , Criança , Diabetes Mellitus Tipo 1/sangue , Feminino , Humanos , Masculino , Resultado do Tratamento
16.
Diabetes Technol Ther ; 21(4): 222-229, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30817171

RESUMO

Continuous glucose monitors (CGM) display real-time glucose values enabling greater glycemic awareness with reduced management burden. Factory-calibrated CGM systems allow for glycemic assessment without the pain and inconvenience of fingerstick glucose testing. Advances in sensor chemistry and CGM algorithms have enabled factory-calibrated systems to have greater accuracy than previous generations of CGM technology. Despite these advances many patients and providers are hesitant about the idea of removing fingerstick testing from their diabetes care. In this commentary, we aim to review the clinical trials on factory-calibrated CGM systems, present the algorithms which facilitate factory-calibrated CGMs to improve accuracy, discuss clinical use of factory-calibrated CGMs, and finally present two cases demonstrating the dangers of utilizing exploits in commercial systems to prolong sensor life.


Assuntos
Automonitorização da Glicemia , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Calibragem , Humanos
17.
Diabetes Technol Ther ; 21(5): 265-272, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30925077

RESUMO

Background: The objective of this study was to assess the safety and performance of the Omnipod® personalized model predictive control (MPC) algorithm with variable glucose setpoints and moderate intensity exercise using an investigational device in adults with type 1 diabetes (T1D). Materials and Methods: A supervised 54-h hybrid closed-loop (HCL) study was conducted in a hotel setting after a 7-day outpatient standard treatment phase. Adults aged 18-65 years with T1D and HbA1c between 6.0% and 10.0% were eligible. Subjects completed two moderate intensity exercise sessions of >30 min duration on consecutive days: the first with the glucose set point increased from 130 to 150 mg/dL and the second with a temporary basal rate of 50%, both started 90 min pre-exercise. Primary endpoints were percentage time in hypoglycemia <70 mg/dL and hyperglycemia ≥250 mg/dL. Results: Twelve subjects participated in the study, with (mean ± standard deviation) age 36.5 ± 14.4 years, diabetes duration 21.7 ± 15.7 years, HbA1c 7.6% ± 1.1%, and total daily dose 0.60 ± 0.22 U/kg. Outcomes for the 54-h HCL period were mean glucose: 136 ± 14 mg/dL, percentage time <70 mg/dL: 1.4% ± 1.3%, 70-180 mg/dL: 85.1% ± 9.3%, and ≥250 mg/dL: 1.8% ± 2.4%. In the 12-h period after exercise start, percentage time <70 mg/dL was 1.4% ± 2.7% with the raised glucose set point and 1.6% ± 3.0% with reduced basal rate. The percentage time <70 mg/dL overnight was 0% ± 0% on both study nights. Conclusions: The Omnipod personalized MPC algorithm performed well and was safe during day and night use in response to variable glucose set points and with temporarily raised glucose set point or reduced basal rate 90 min in advance of moderate intensity exercise in adults with T1D.


Assuntos
Automonitorização da Glicemia/instrumentação , Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Sistemas de Infusão de Insulina , Insulina/uso terapêutico , Adolescente , Adulto , Idoso , Algoritmos , Diabetes Mellitus Tipo 1/sangue , Exercício , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
18.
Blood Adv ; 3(3): 350-359, 2019 02 12.
Artigo em Inglês | MEDLINE | ID: mdl-30718242

RESUMO

Malglycemia (hypoglycemia, hyperglycemia, and/or glycemic variability) in adult hematopoietic stem cell transplant (HSCT) recipients is associated with increased infection, graft-versus-host disease, organ dysfunction, delayed engraftment, and mortality. Malglycemia has not been studied in pediatric HSCT recipients. This study aimed to characterize the incidence and consequences of malglycemia in this population. Medical records for a cohort of 344 patients, age 0 to 30 years, who underwent first HSCT from 2007 to 2016 at Children's Hospital Colorado were retrospectively reviewed. Glucose data were analyzed in intervals and assessed for potential risk factors and associated outcomes. Malglycemia occurred in 43.9% of patients. Patients with a day 0 to 100 mean glucose of 100 to 124 mg/dL had a 1.76-fold (95% confidence interval [CI], 1.10-2.82; P = .02) increased risk of death and patients with a day 0 to 100 mean glucose ≥ 125 mg/dL had a 7.06-fold (95% CI, 3.84-12.99; P < .0001) increased risk of death compared with patients with a day 0 to 100 mean glucose < 100 mg/dL. For each 10 mg/dL increase in pre-HSCT glucose, there was a 1.11-fold (95% CI, 1.04-1.18; P = .0013) increased risk of post-HSCT infection. These adverse impacts of malglycemia occurred independent of transplant type, graft-versus-host disease, and steroid therapy. Malglycemia in the pediatric HSCT population is independently associated with significantly increased risk of morbidity and mortality. Further research is required to evaluate the utility of glucose control to mitigate these relationships and improve HSCT outcomes. This trial was registered at www.clinicaltrials.gov as #NCT03482154.

19.
Diabetes Technol Ther ; 21(2): 73-80, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30649925

RESUMO

BACKGROUND: Use of artificial pancreas (AP) requires seamless interaction of device components, such as continuous glucose monitor (CGM), insulin pump, and control algorithm. Mobile AP configurations also include a smartphone as computational hub and gateway to cloud applications (e.g., remote monitoring and data review and analysis). This International Diabetes Closed-Loop study was designed to demonstrate and evaluate the operation of the inControl AP using different CGMs and pump modalities without changes to the user interface, user experience, and underlying controller. METHODS: Forty-three patients with type 1 diabetes (T1D) were enrolled at 10 clinical centers (7 United States, 3 Europe) and 41 were included in the analyses (39% female, >95% non-Hispanic white, median T1D duration 16 years, median HbA1c 7.4%). Two CGMs and two insulin pumps were tested by different study participants/sites using the same system hub (a smartphone) during 2 weeks of in-home use. RESULTS: The major difference between the system components was the stability of their wireless connections with the smartphone. The two sensors achieved similar rates of connectivity as measured by percentage time in closed loop (75% and 75%); however, the two pumps had markedly different closed-loop adherence (66% vs. 87%). When connected, all system configurations achieved similar glycemic outcomes on AP control (73% [mean] time in range: 70-180 mg/dL, and 1.7% [median] time <70 mg/dL). CONCLUSIONS: CGMs and insulin pumps can be interchangeable in the same Mobile AP system, as long as these devices achieve certain levels of reliability and wireless connection stability.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Pâncreas Artificial , Adolescente , Adulto , Idoso , Algoritmos , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/sangue , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Smartphone , Resultado do Tratamento , Adulto Jovem
20.
Diabetes Technol Ther ; 21(1): 11-19, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30585770

RESUMO

OBJECTIVE: To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ technology in children with type 1 diabetes (T1D). METHODS: Participants (N = 105, ages 7-13 years, mean age 10.8 ± 1.8 years) were enrolled at nine centers (eight in the United States and one in Israel) and completed a 2-week baseline run-in phase in Manual Mode followed by a 3-month study phase with Auto Mode enabled. Sensor glucose (SG), glycated hemoglobin (HbA1c), percentage of SG values across glucose ranges, and SG variability, during the run-in and study phases were compared. Participants underwent frequent sample testing with i-STAT® venous reference measurement during a hotel period (6 days/5 nights) to evaluate the system's continuous glucose monitoring performance. RESULTS: Auto Mode was used a median of 81% of the time. From baseline to end of study, overall SG dropped by 6.9 ± 17.2 mg/dL (P < 0.001), HbA1c decreased from 7.9% ± 0.8% to 7.5% ± 0.6% (P < 0.001), percentage of time in target glucose range (70-180 mg/dL) increased from 56.2% ± 11.4% to 65.0% ± 7.7% (P < 0.001), and the SG coefficient of variation decreased from 39.6% ± 5.4% to 38.5% ± 3.8% (P = 0.009). The percentage of SG values within target glucose range was 68.2% ± 9.1% and that of i-STAT reference values was 65.6% ± 17.7%. The percentage of values within 20%/20 of the i-STAT reference was 85.2%. There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the study phase. CONCLUSION: In-home use of MiniMed 670G system Auto Mode for 3 months by children with T1D, similar to MiniMed 670G system use by adolescents and adults with T1D, was safe and associated with reduced HbA1c levels and increased time in target glucose range, compared with baseline.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina/estatística & dados numéricos , Insulina/administração & dosagem , Adolescente , Glicemia/análise , Automonitorização da Glicemia , Criança , Diabetes Mellitus Tipo 1/sangue , Feminino , Hemoglobina A Glicada/análise , Humanos , Masculino , Resultado do Tratamento
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