Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes
Lauren G. KanapkaR. Paul WadwaMarc D. BretonKatrina J. RuedyLaya EkhlaspourGregory P. ForlenzaEda CengizMelissa J. SchoelwerEmily JostLori CarriaEmma EmoryLiana HsuStuart A. WeinzimerMark D. DeBoerBruce A. BuckinghamMary C. OliveriCraig KollmanBetsy B. DokkenDaniel R. CherñavvskyRoy W. Beckthe iDCL Trial Research Group
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<b>Objective: </b>To further evaluate the safety and efficacy of the Control-IQ closed loop control (CLC) system in children with type 1 diabetes.<b></b> <p><b>Research Design and Methods: </b>Following a 16-week randomized clinical trial (RCT) comparing CLC with sensor augmented pump (SAP) therapy in 101 children age 6 to 13 years old with type 1 diabetes, 22 participants in the SAP group initiated use of the CLC system (referred to as SAP-CLC cohort), and 78 participants in the CLC group continued use of CLC (CLC-CLC cohort) for 12 weeks. </p> <p><b>Results: </b>In the SAP-CLC cohort, mean percentage of time in range 70-180 mg/dL (TIR) increased from 55±13% using SAP during the RCT to 65±10% using CLC (P<0.001), with 36% of the cohort achieving TIR >70% plus time <54 mg/dL <1% compared with 14% when using SAP (P=0.03). Substantial improvement in TIR was seen after the first day of CLC. Time <70 mg/dL decreased from 1.80% to 1.34% (P<0.001). In the CLC-CLC cohort, mean TIR increased from 53±17% pre-randomization to 67±10% during the RCT and remained reasonably stable at 66±10% through the 12-weeks post-RCT. There were no episodes of diabetic ketoacidosis or severe hypoglycemia in either cohort.</p> <p><b>Conclusions: </b> This further evaluation of the Control-IQ CLC system supports the findings of the preceding RCT that use of a closed-loop system can safely improve glycemic control in children 6 to 13 years old with type 1 diabetes from the first day of use and demonstrates that these improvements can be sustained through 28 weeks of use. </p>Keywords:
Diabetic ketoacidosis
Randomized controlled trials are considered to be the gold standard in clinical studies to establish level of evidence in medical research. But, they are not easy to conduct and various other aspects have to be looked into. Randomization offers each enrolled subject equal chance of being allocated to the intervention and the control groups. Randomized control trial (RCT) is most powerful tool in clinical research. In this, subjects are assigned to different groups of interventions by chance for comparison. RCT is only study design which can help us evaluate a new treatment. By assigning participants to different intervention groups by chance, comparison between the interventions groups is made. Purpose of randomization is to make the treatment groups comparable, eliminates the source of and it ensures that the difference in groups is only due to trial treatments. In this article, we review randomized control trial with special emphasis on various types of randomized controlled trials, their characteristics, the process of randomization, and advantages and drawbacks of randomized controlled trials. Key words: Randmized controlled trials, study design, randomization, clinical research
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Introduction: The COVID-19 pandemic has had a significant impact the region of Lombardy, causing more than 16,000 deaths. Fortunately, children, including those with type 1 diabetes (T1DM), were only slightly affected. It is debated as to whether COVID-19 infection may increase the incidence of T1DM in children and whether the conditions during and following lockdown may have led to an increased number of diabetic ketoacidosis (DKA) at onset. Objectives: To assess the impact of COVID-19 on T1DM and DKA incidence. Methods: A network of 11 regional pediatric T1DM clinics collected data in children of ages 0-18 years during the time period between March 1-May 31 in the years 2017-2020. Given that all T1DM children are hospitalized at onset and rarely escape this network of regional clinics, it was possible to define a minimal incidence of T1DM without a secondary source, Results: Number of onsets was stable (2017: 206 cases/year, 2018: 199 cases/year, 2019: 233 cases/year, 2020: 105 cases/5 months). DKA at onset varied between 36 and 40% of new onsets. By comparing the cases in the period March 1-May 302,017-2020, an increase in DKA incidence at onset from 11 to 24/1.7 million (p < 003) was found. The minimum regional incidence of T1DM showed a slight increase from 11.7 to 13.7 cases/100000 (0-18 years of age), comparable to previously collected regional data from 2008. Conclusion: These data suggest that COVID-19 infection in Lombardy was not correlated with an in increased T1DM incidence. Furthermore, the minimum regional incidence of TIDM in ages 0-18 years seems stable in the last 10 years. However, a significant increase in the number of DKA at onset was found, many of which were reported to be severe and probably consequent to delayed hospital presentation due to lockdown restrictions and fear of infection, emphasizing the indirect deleterious impact of pandemics on potentially lifethreatening conditions such as DKA.
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2019-20 coronavirus outbreak
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Objective To study the correlation between the levels of serum 25-(OH)D and the children with type 1 diabetes mellitus(T1DM)and diabetic ketoacidosis(DKA).Methods Fifty-two cases with newly diagnosed T1DM were selected from 152 cases who stayed in hospital from January 2006 to November 2009,21 cases with DKA and 31 cases without DKA.One hurdred children excluded from T1DM according to the standard of T1DM were was selected.Serum 25-(OH)D was measured and compared among three groups.The relationship between the levels of serum 25-(OH)D and the children with T1DM,DKA was analyzed.Results The levels of serum 25-(OH)D in cases with DKA(53.6 ± 27.8 nmol/L)were lower than those in cases without DKA(69.7 ± 27.9 nmol/L)and children without T1DM(81.8 ± 28.3 nmol/L)(P 0.05).The levels of serum 25-(OH)D in cases without DKA were lower than those in children without T1DM(P 0.05).Conclusions The levels of serum 25-(OH)D in children with T1DM are low,especially in children with DKA.The potential protective effect of 25-(OH)D on the development of T1DM should be noticed.
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Diabetic ketoacidosis (DKA) is a life threatening condition in people with type 1 diabetes (T1D).[1][1] With 10–30% of people in developed countries on insulin pump therapy for managing T1D, DKA in such patients can result in fatal or near-fatal consequences.[2][2]–[4][3] Despite its severity,
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Objective: Diabetic ketoacidosis (DKA) is a preventable complication in youth with type 1 diabetes (T1D). This study aimed to estimate the incidence trend of DKA at T1D diagnosis (DKA-AT, defined as DKA within 14 days of T1D diagnosis) and after T1D diagnosis (DKA-AFTER, defined as DKA after 14 days of T1D diagnosis) from 2002 to 2012 in British Columbia, Canada. Methods: We used a previously described population-based cohort of individuals diagnosed with T1D at <20 years of age. DKA episodes were identified using ICD9/10 codes (250.1X/E101X). Incidence rate ratio (IRR) was estimated using Poisson regression and trends in DKA rates were examined using Joinpoint regression analyses. Results: 2615 incident cases of T1D were identified between 2002 and 2012, of which 847 (32.4%) were diagnosed with DKA-AT. 52% were male. The rates of DKA-AT by year ranged between 24.1% (2008) and 37.3% (2006). No sex differences were observed. The IRR was 2.0 (95% CI: 1.6, 2.5; p<0.001) for those diagnosed with T1D at 0-4 years compared to those diagnosed at 15-19 years old, after adjusting for the trend by fiscal year. In the same period, 1886 episodes of DKA-AFTER were identified with a consistent increase from 5.3% (2002) to 9.5% (2012). The IRR for DKA-AFTER in children 0-4 years old at diabetes diagnosis was 9.13 (95% CI: 7.73, 10.77; p<0.001). After adjusting for the increasing trend by fiscal year, females had higher rates of DKA-AFTER than males (IRR 1.45, 95% CI: 1.33, 1.59; p<0.001). The average annual percent change for DKA-AFTER was 4.91% (95% CI: 2.69, 7.18; p<0.001). Conclusions: DKA-AT incidence remained unchanged while the incidence of DKA-AFTER increased over time, with the greatest burden in those diagnosed at a younger age. Targeted interventions are needed to raise public awareness to prevent DKA-AT and to educate patients and families in preventing DKA-AFTER. Disclosure K. Kao: None. N. Islam: None. D.A. Fox: None. S. Amed: None.
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OBJECTIVE We studied the prevalence of diabetic ketoacidosis (DKA) at diagnosis of type 1 diabetes in children in Finland. RESEARCH DESIGN AND METHODS From 2002 to 2005, data on virtually all children <15 years of age diagnosed with type 1 diabetes (n = 1,656) in Finland were collected. RESULTS DKA was present in 19.4% of the case subjects, and 4.3% had severe DKA. In children aged 0–4, 5–9, and 10–14 years, DKA was present in 16.5, 14.8, and 26.4%, respectively (P < 0.001). Severe DKA occurred in 3.7, 3.1, and 5.9%, respectively (P = 0.048). DKA was present in 30.1% and severe DKA in 7.8% of children aged <2 years. CONCLUSION The overall frequency of DKA in children is low in Finland at diagnosis of type 1 diabetes. However, both children <2 years of age and adolescents aged 10–14 years are at increased risk of DKA.
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Diabetic ketoacidosis (DKA) is a potentially life threatening acute complication of Type I diabetes mellitus (T1DM). This study aimed to determine the frequency and clinical characteristics of pediatric DKA at diagnosis of new-onset T1DM in Khartoum during 2000-2017 period.The study was retrospective and involved review of medical files of children (<15 years) with T1DM in the city hospitals and diabetes centers.The overall frequency of DKA among T1DM children at onset of disease diagnosis was 17.6% (173/982). The episodes of DKA increased from 26% in first 6- year period (2000-2005) to 46.3% in the last 6-year period (2011-2012; p<0.001). No significant difference in the frequency of DKA was observed according to gender (p=0.9) and age (p=0.24). Compared to other age groups, the severity of DKA (pH<7.1) was higher in pre-school children (p<0.01). Approximately, 5% of patients were complicated with cerebral edema with a mortality rate of 1.7%.The DKA frequency at diagnosis of childhood T1DM in Khartoum was lower than previous reports. In addition, the severity of DKA was high among pre-school age children with a relatively high mortality rate when compared to the global rate.
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Diabetic ketoacidosis (DKA) is a life-threatening complication of type 1 diabetes (T1D). The aim of this study is to analyze the incidence, clinical characteristics, management and outcome of children presenting with DKA in new-onset T1D from 2008 to 2018 in Hong Kong.Data was extracted from the Hong Kong Childhood Diabetes Registry. All subjects less than 18 years with newly diagnosed T1D from 1 January 2008 to 31 December 2018 managed in the public hospitals were included. Information on demographics, laboratory parameters, DKA-related complications and management were analyzed.In the study period, there were 556 children with newly diagnosed T1D in our registry and 43.3% presented with DKA. The crude incidence rate of new-onset T1D with DKA was 1.79 per 100,000 persons/year (CI: 1.56-2.04). Subjects presenting with DKA were younger (9.5 ± 4.5 vs. 10.5 ± 4.4, p=0.01) and had shorter duration of symptoms (4.2 ± 5.9 days vs. 10.6 ± 17.1 days, p<0.01). Regarding management, up to 12.4% were given insulin boluses and 82.6% were started on insulin infusion 1 h after fluid resuscitation. The rate of cerebral edema was 0.8% and there was no mortality.Younger age and shorter duration of symptoms were associated with DKA in new-onset T1D. Despite availability of international guidelines, there was inconsistency in acute DKA management. These call for a need to raise public awareness on childhood diabetes as well as standardization of practice in management of pediatric DKA in Hong Kong.
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Diabetic ketoacidosis (DKA) is a potentially life-threatening metabolic disorder that can occur with manifestation of type 1 diabetes mellitus (T1D). The aim of this study was to analyze the incidence of DKA at the time of the diagnosis of T1D in childhood and adolescence, the risk factors, and regional approaches to reduce the incidence of ketoacidosis.We investigated the proportion of patients under 18 years of age with DKA (defined as pH <7.3, severe DKA pH <7.1) at the manifestation of T1D in Germany in the period 2000-2019, based on data from the German-Austrian registry of diabetes (Diabetes-Patienten-Verlaufsdokumentation, DPV). The influence of the following factors was evaluated: year of manifestation, age, sex, family history of migration (MiH), and distance from the hospital. Moreover, data from the region with and the region without a pilot screening project from 2015 onwards were compared.Of the 41 189 patients with manifestation of T1D, 19.8% presented with DKA (n = 8154, slight increase [p <0.001] over the study period) and 6.1% (n = 2513) had severe DKA. Children under 6 years of age had DKA more often than adolescents (12-17 years) (21.7% versus 18.6%, OR 1.22 {95% CI: [1.14; 1.30]}). Girls had a higher rate of DKA than boys (20.5% versus 19.2%, OR 1.10 [1.03; 1.14]), and patients with MiH were more likely to have DKA than those without MiH (21.4% versus 18.2%, OR 1.40 [1.32; 1.48]). In the region with a pilot screening project, the DKA rate stayed the same, at 20.6%, while in the control region the rate was 22.7% with a decreasing tendency.The frequency of DKA at the time of diagnosis of T1D did not decrease between 2000 and 2019 and increased towards the end of the observation period. Children with MiH, children under 6, and girls were at a higher risk of DKA.
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