Does introduction of continuous glucose monitoring at diagnosis of type 1 diabetes increase uptake in children and adolescents?

OBJECTIVE: To assess whether introduction of continuous glucose monitoring (CGM) at diagnosis of type 1 diabetes (T1D), leads to greater uptake and continuation at 12 and 24 months, in a population-based pediatric diabetes clinic. RESEARCH DESIGN AND METHODS: All T1D children and adolescents diagnosed in the 12 months following full government subsidization of CGM were offered CGM from diagnosis at Women's and Children's Hospital, SA (Cohort 1). Uptake and continuation of CGM was compared to those diagnosed in the preceding year, who were started on CGM after diagnosis, but otherwise had identical diabetes management (Cohort 2). Demographic and clinical data were collected prospectively. The primary outcome variable was CGM wear >75% of the time at 12 and 24 months. RESULTS: In Cohort 1, 84% were started on CGM at diagnosis. 88% had commenced CGM by 12 months and 90% by 24 months. In Cohort 2, CGM was started on average 10 months after diagnosis (range 1-25 months), with 81% started on CGM within 24 months of subsidization. At 24 months, 78% of Cohort 1 and 66% of Cohort 2 were wearing CGM >75% of the time (p = 0.26), higher than the WCH Clinic as a whole (58%). There was no difference in HbA1c between cohorts. CONCLUSION: Starting CGM at diagnosis of T1D is feasible and well received by families, with high uptake across all ages. Although CGM continuation (wearing CGM >75% of the time) was slightly higher in Cohort 1 than Cohort 2, this did not reach statistical significance.

Canadian Real-World Outcomes of Omnipod Initiation in People with Type 1 Diabetes (COPPER study): Evidence from the LMC Diabetes Registry.

AIMS: To investigate real-world clinical outcomes in adults with type 1 diabetes who initiated the Omnipod Insulin Management System (Insulet Corp., Acton, MA, USA) compared to a matched cohort who maintained multiple daily injection therapy. METHODS: This retrospective observational study used data from the Canadian LMC Diabetes Registry. Adults with type 1 diabetes who switched from multiple daily injections to the Omnipod system as usual standard of care between January 2011 and April 2019 were matched to a cohort of adults with type 1 diabetes who maintained multiple daily injection therapy, using propensity-score matching. The primary outcome was change in HbA1c at 3- to 6-month follow-up. RESULTS: Propensity-score matching resulted in a final analytical cohort of 286 individuals (143/cohort). HbA1c in the Omnipod cohort was reduced by a mean ± sd of -3 ± 10 mmol/mol (-0.2 ± 1.0%; P = 0.005) with no change in the MDI cohort [0 ± 10 mmol/mol (0.0 ± 1.0%); P = 0.74]. HbA1c change was seen only in persons with baseline HbA1c ≥75 mmol/mol (≥9.0%) [Omnipod cohort: -15 ± 12 mmol/mol (-1.4 ± 1.1%); P < 0.001] with a between-treatment difference [mean (95% CI)] of -12 (-18, -6) mmol/mol [-1.1 (-1.6, -0.5) %, P < 0.001]. The median total daily dose of insulin was lower following Omnipod initiation (baseline 0.63 U/kg vs follow-up 0.53 U/kg; P < 0.001), with no change in the MDI cohort (baseline 0.68 U/kg vs follow-up 0.67 U/kg; P = 0.23). CONCLUSIONS: Adults with type 1 diabetes who initiated use of the Omnipod system in a real-world clinical setting had lower HbA1c and total daily dose of insulin at 3- to 6-month follow-up compared to a matched cohort of adults who maintained multiple daily injection therapy. A treatment difference in HbA1c change was seen only in people with baseline HbA1c ≥ 75 mmol/mol (9.0%). (Clinical trials registration: NCT04226378).

First year on commercial hybrid closed-loop system-experience on 111 children and adolescents with type 1 diabetes.

OBJECTIVE: The hybrid close-loop system (HCL) is a rapidly emerging treatment method for type 1 diabetes (T1D), but the long-term effectiveness of the system remains unclear. This study investigates the influence of the HCL on glycemic control in children and adolescents with T1D in a real-life setting during the first year on HCL. RESEARCH DESIGN AND METHODS: This retrospective study included all the patients (n = 111) aged 3 to 16 years with T1D who initiated the HCL system between 1st of December 2018 and 1st of December 2019 in the Helsinki University Hospital. Time in range (TIR), HbA1c, mean sensor glucose (SG) value, time below range (TBR), and SG coefficient of variance (CV) were measured at 0, 1, 3, 6, and 12 month. The changes over time were analyzed with a repeated mixed model adjusted with baseline glycemic control. RESULTS: After the initiation of HCL, all measures of glycemic control, except HbA1c, improved and the effect lasted throughout the study period. Between 0 and 12 month, TIR increased (ß = -2.5 [95%CI: -3.6 - (-1.3)], p < 0.001), whereas mean SG values (ß = -0.7 [95%CI: -0.9 - (-0.4)]), TBR (ß = -2.5 [95%CI: -3.6 - (-1.3)]), and SG CV (ß = -4.5 [95%CI: -6.3 - [-2.8]) decreased significantly (p < 0.001). Importantly, the changes occurred regardless of the age of the patient. CONCLUSIONS: Measurements of glycemic control, except HbA1c, improved significantly after the initiation of the HCL system and the favorable effect lasted throughout the follow-up. These results support the view that HCL is an efficacious treatment modality for children and adolescents with T1D of all ages.

Expect the unexpected: Adolescent and pre-teens' experience of diabetes technology self-management.

OBJECTIVE: Only 17% of adolescents with type 1 diabetes (T1D) are currently meeting their glycemic targets despite advances in diabetes technologies. Self-management behaviors and challenges specific to use of diabetes technologies are insufficiently studied in adolescents. We aimed to describe the experience of diabetes technology self-management, including facilitators and barriers, among preteens/adolescents with low and high A1C. RESEARCH DESIGN AND METHODS: Youth (10-18 years of age) with T1D who use insulin pump therapy were recruited from the larger quantitative cohort of a mixed methods study for participation in semi-structured qualitative interviews. Maximum variability sampling was used to recruit youth with A1C <7.5% (n = 5) and A1C >9% (n = 5). Participants' personal insulin pump and continuous glucose monitoring data were downloaded and served as a visual reference. Interviews were analyzed using a qualitative descriptive approach. RESULTS: Participants were 50% female with a median age of 14.9 years and 80% used CGM. The sample was predominantly white (90.0%). Analysis produced four major themes, Bad Day, Expect the Unexpected, Nighttime Dependence, and Unpredictability, It's Really a Team and interconnecting subthemes. Youth characterized ''Bad Days'' as those requiring increased diabetes focus and self-management effort. The unpredictability (''Expect the Unexpected'') of glucose outcomes despite attention to self-management behaviors was considerable frustration. CONCLUSIONS: Diabetes devices such as insulin pumps are complex machines that rely heavily on individual proficiency, surveillance, and self-management behaviors to achieve clinical benefit. Our findings highlight the dynamic nature of self-management and the multitude of factors that feed youths' self-management behaviors.

Racial disparities in treatment and outcomes of children with type 1 diabetes.

OBJECTIVE: The aim of this study was to assess racial disparities in treatments and outcomes between Non-Hispanic black (NHB), Hispanic and Non-Hispanic white (NHW) children with type 1 diabetes (T1D). METHODS: We reviewed electronic health records of children (<18 years) attending a large, pediatric tertiary care diabetes center in the United States between October 1, 2018, and December 31, 2019. Health care utilization (appointment attendance, ED visits, hospitalizations), technology use (insulin pumps, continuous glucose monitors [CGM]) and hemoglobin A1c (HbA1c) were examined for each race/ethnicity and stratified by insurance type (private/government) as a proxy for socioeconomic status (SES). RESULTS: Of 1331 children (47% female) with a median (IQR) age of 14.2 (11.5, 16.3) years and T1D duration of 5.8 (3.8, 9) years; 1026 (77%) were NHW, 198 (15%) NHB, and 107 (8%) Hispanic. Government insurance was used by 358 (27%) children, representing 60% of NHB and 53% of Hispanic, but only 18% of NHW children. NHB children had higher HbA1c, more ED visits and hospitalizations, and were less likely to be treated with insulin pumps or CGM than NHW children (P < .001 for all). There were no racial disparities with regard to the number of appointments attended. CONCLUSIONS: Racial disparities in technology use and diabetes outcomes persist in children with T1D, regardless of insurance status. To ensure equitable care, pediatric healthcare providers should remain cognizant of racial disparities in diabetes treatment. The impact of provider and patient factors should be explored when studying the etiology of these health disparities.

Self-reported insulin pump prescribing practices in pediatric type 1 diabetes.

INTRODUCTION: Disadvantaged and minority youth with type 1 diabetes are less likely to be on insulin pump therapy compared to the majority population. Little is known about how pediatric endocrinology providers determine eligibility for insulin pump. We aimed to identify provider factors influencing the decision to initiate insulin pump therapy. METHODS: We conducted a survey of Pediatric Endocrine Society members who prescribe insulin pump therapy to pediatric patients with type 1 diabetes. The survey collected information about prescriber characteristics, use and adherence to guidelines, eligibility criteria, and objective and subjective factors that influence insulin pump prescription. RESULTS: The survey was completed by 192 individuals who met eligibility criteria (14.1% response rate). The majority of respondents were attending providers, and were white, non-Hispanic females. A minority of providers (22%) reported following written insulin pump guidelines, and many (70%) reported using personal guidelines to guide patient selection. Most providers had no objective eligibility criteria, aside from standard glucose monitoring. Providers identified patient lifestyle and increased risk of hypoglycemia, as well as patient and family factors such as motivation, realistic expectations of insulin pump use, ability to demonstrate carbohydrate counting, patient request, and ability to communicate as important in the decision to initiate insulin pump. CONCLUSION: Pediatric endocrinology providers place significant importance on subjective factors and utilize few objective criteria in determining eligibility for insulin pump. In the setting of the known disparities in insulin pump use, providers should utilize objective, consistent criteria to determine which patients are safe to initiate insulin pump.

Factors associated with withdrawal from insulin pump therapy: A large-population-based study.

BACKGROUND: Although, number of diabetic patients received insulin pump (IP) therapy is increasing; there are limited data regarding factors associated with IP withdrawal. METHODS: We conducted a cross-sectional study using data from an Israeli health maintenance organization. All patients, 21 or older, with type 1 (T1DM) or type 2 (T2DM) diabetes, who received IP therapy for a 7-year period were identified. Patients who did not purchase IP maintenance supplies for at least six consecutive months were defined as withdrawn (N = 355). Patients who purchased supplies were defined as adherent (N = 352). RESULTS: In both T1DM and T2DM patients, withdrawal from IP therapy was positively associated with duration of diabetes longer than 5 years (odds ratio [OR] = 13.26 [CI, 7.16-23.34; P < .001] and OR = 10.92 [CI, 5.64-21.14; P < .001], respectively), nonadherence to dietician follow-up (OR = 5.78 [CI, 3.65-9.14; P < .001] and OR = 3.41 [CI, 1.99-5.85; P < .001], respectively), and poor glycaemic control prior to IP treatment (OR = 4.04 [CI, 2.18-7.48; P < .001] and OR = 4.59 [CI, 2.71-7.81; P < .001], respectively]. Co-morbid neuro-psychiatric disorders were also risk factors for IP withdrawal: diagnosis of depression (OR = 2.22 [CI, 1.16-4.27; P = .017] and Attention Deficit Hyperactivity Disorder (ADHD) OR = 2.45 [CI, 1.003-5.087; P = .043]) among T1DM patients; and diagnosis of depression (OR = 1.85 [CI, 1.05-5.27; P = .046] and dementia OR = 4.03 [CI, 1.03-19.77; P = .048]) among T2DM patients. CONCLUSION: In our large real-world population-based study, we found that smoking, obesity, poor glycaemic control, and co-morbid neuro-psychiatric disorders were associated with a high rate of withdrawal from IP therapy. Health care providers ought to familiarize themselves with patient characteristics predictive of nonadherence and should intensify patient follow-up when incorporating this new, costly, and challenging technology.

Glyco-metabolic control, inflammation markers, and cardiovascular outcomes in type 1 and type 2 diabetic patients on insulin pump or multiple daily injection (italico study).

BACKGROUND: To evaluate if the positive effects recorded on glycaemic control with continuous subcutaneous insulin infusion (CSII) were maintained on the long-term compared with multiple daily injection (MDI). The secondary objective was to evaluate if there is a reduction of type and number of cardiovascular events (CV). METHODS: This retrospective, observational study evaluated glycaemic control and the number of CV in 104 patients with type 1 or 2 diabetes previously treated with MDI and initiating CSII therapy with tubed insulin pumps compared with 109 patients previously treated with MDI continuing MDI. RESULTS: After 8 years, the glycaemic control including glycated haemoglobin (HbA1c ), fasting plasma glucose (FPG), and prandial plasma glucose (PPG) improved with both CSII and MDI compared with baseline; however, HbA1c , FPG, and PPG recorded with CSII were lower than data recorded with MDI. During the 8 years, there were fewer CV events with CSII, compared with MDI, and in particular, there were fewer cases of atrial fibrillation, premature ventricular contractions, acute coronary infarction, angina pectoris, heart failure, and peripheral vascular ischemia. We did not record any reduction of ischemic stroke events. CONCLUSION: Our preliminary data suggest that CSII treatment seems to reduce the rates of CV compared with MDI therapy. Moreover, CSII also improved glycaemic control, without increasing the number of hypoglycaemia. However, given the observational design of this trial, our data should be validated in a randomized clinical trial; if they will be confirmed, CSII could be chosen for fully informed and motivated patients at higher risk of developing CV.

How does a predictive low glucose suspend (PLGS) system tackle pediatric lifespan challenges in diabetes treatment? Real world data analysis.

OBJECTIVES: The aim of the study was to assess the benefits of a predictive low glucose suspend (PLGS) system in real-life in children and adolescents with type 1 diabetes of different age and age-related clinical challenges. METHODS: Real life retrospective and descriptive analysis included 44 children (26 girls) with type 1 diabetes who were introduced to PLGS system. We divided them in three age groups: I (3-6 years old, n = 12), II (7-10 y/o, n = 16), III (11-19 y/o, n = 16). All children and their caregivers received unified training in self-management during PLGS therapy. Patients' data included: age, HbA1C levels, sex. While from the CGM metric, we obtained: time of sensor use (SENSuse), time in range (TiR): in, below and over target range and average blood glycemia (AVG), insulin suspension time (INSsusp). RESULTS: SENSuse was 93% in total, with 92%, 94%, and 87% in age groups I, II, III, respectively. In total the reduction of mean HbA1C from 7.61% to 6.88% (P < .05), while for the I, II, and III it was 7.46% to 6.72%, 6.91% to 6.41%, and 8.46 to 7.44%, respectively (P < .05). Although we observed a significant reduction of HbA1C, the time below target range was minimal. Specific findings included: group I-longest INSsusp (17%), group II-lowest glycemic variability (CV) (36%), and group III-highest AVG (169 mg/dL). There was a reverse correlation between suspend before low and age (-0.32, P < .05). In group I CV reduced TiR in target range (TiRin) (-0.82, P < .05), in group II use of complex boluses increased TiRin (0.52, P < .05). In group III higher CV increased HbA1C (0.64, P < .05) while reducing TiRin (-0.72, P < .05). CONCLUSIONS: PLGS is a suitable and safe therapeutic option for children with diabetes of all age and it is effective in addressing age-specific challenges. PLGS improves glycemic control in children of all age, positively affecting its different parameters.

Six months of hybrid closed loop in the real-world: An evaluation of children and young adults using the 670G system.

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.

Changing costs of type 1 diabetes care among US children and adolescents.

BACKGROUND: Modern therapy for type 1 diabetes (T1D) increasingly utilizes technology such as insulin pumps and continuous glucose monitors (CGMs). Prior analyses suggest that T1D costs are driven by preventable hospitalizations, but recent escalations in insulin prices and use of technology may have changed the cost landscape. METHODS: We conducted a retrospective analysis of T1D medical costs from 2012 to 2016 using the OptumLabs Data Warehouse, a comprehensive database of deidentified administrative claims for commercial insurance enrollees. Our study population included 9445 individuals aged ≤18 years with T1D and ≥13 months of continuous enrollment. Costs were categorized into ambulatory care, hospital care, insulin, diabetes technology, and diabetes supplies. Mean costs for each category in each year were adjusted for inflation, as well as patient-level covariates including age, sex, race, census region, and mental health comorbidity. RESULTS: Mean annual cost of T1D care increased from $11 178 in 2012 to $17 060 in 2016, driven primarily by growth in the cost of insulin ($3285 to $6255) and cost of diabetes technology ($1747 to $4581). CONCLUSIONS: Our findings suggest that the cost of T1D care is now driven by mounting insulin prices and growing utilization and cost of diabetes technology. Given the positive effects of pumps and CGMs on T1D health outcomes, it is possible that short-term costs are offset by future savings. Long-term cost-effectiveness analyses should be undertaken to inform providers, payers, and policy-makers about how to support optimal T1D care in an era of increasing reliance on therapeutic technology.

Evaluating Feasibility of Personal Diabetes Device Data Collection for Research.

BACKGROUND: Diabetes devices, like insulin pumps and continuous glucose monitors (CGMs), capture and store patient adherence and utilization data that can be retrieved or downloaded providing objective information on self-management behaviors; yet, diabetes device data remain underutilized in research. OBJECTIVE: The aim of the study was to examine the usability and feasibility of personal diabetes device data collected using a clinical download platform retooled for research purposes. METHODS: Investigators evaluated the feasibility of raw diabetes device data collection. One hundred eight preteens and adolescents with Type 1 diabetes and their parents provided consent/assent. RESULTS: Data were successfully collected from the diabetes devices (insulin pumps and CGM) of 97 youth using a clinical download software adapted for research, including data from all three commercially available CGM systems and insulin pumps brands, which contained all current and previous models of each insulin pump brand. The time required to download, mode of connection, and process varied significantly between brands. Despite the use of an agnostic download software, some outdated device brands and cloud-based CGM data were unsupported during data collection. Within the download software, dummy clinical accounts were created for each study participant, which were then linked back to a master study account for data retrieval. Raw device data were extracted into seven to eight Excel files per participant, which were then used to develop aggregate daily measures. DISCUSSION: Our analysis is the first of its kind to examine the feasibility of raw diabetes device data using a clinical download software. The investigators highlight issues encountered throughout the research process, along with mitigating strategies to inform future inquiry. CONCLUSION: This study demonstrates the feasibility of raw data collection, from a wide variety of insulin pump and CGM brands, through the retooling of a clinical download software. Data from these personal devices provide a unique opportunity to study self-management behavior and the glycemic response of individuals in their everyday environments.

Autism spectrum disorder in children with Type 1 diabetes.

AIM: Links between autism spectrum disorder (ASD) and autoimmune diseases, including Type 1 diabetes have been proposed. This study assessed the frequency of ASD in children with Type 1 diabetes in the T1D Exchange (T1DX) registry and the impact of ASD on characteristics of children with Type 1 diabetes. METHODS: Analysis included 10 032 participants aged < 18 years (median Type 1 diabetes duration 6.5 years, 48% female, 77% non-Hispanic White). Diagnosis of ASD was defined as autism, Asperger's or pervasive developmental disorder. RESULTS: A diagnosis of ASD was recorded for 159 (1.58%) participants. Those with ASD were predominantly male (88% vs. 51% of those without ASD, P < 0.001) and slightly older (median 14 vs. 13 years, P = 0.022). Occurrence of diabetic ketoacidosis at Type 1 diabetes diagnosis was similar (35% vs. 41%, P = 0.161). Pump use was lower in those with ASD (51% vs. 63%, P = 0.005) but continuous glucose monitor use was similar (24% vs. 27%, P = 0.351). Median HbA1c was slightly lower in those with ASD [68 vs. 69 mmol/mol (8.4% vs. 8.5%), P = 0.006]. This difference was more pronounced after adjusting for confounders. CONCLUSIONS: The frequency of ASD in the T1DX registry was similar to that in the general population. These data show that despite deficits in communication, occurrence of diabetic ketoacidosis was similar in youth with and without ASD. Pump use was less frequent in those with ASD, possibly due to sensory issues, although CGM use did not differ. The lower HbA1c may be due to a more regimented routine with ASD. Because comorbidities such as ASD complicate care of patients with Type 1 diabetes, further research is needed to support these children.

The impact of using a closed-loop system on food choices and eating practices among people with Type 1 diabetes: a qualitative study involving adults, teenagers and parents.

AIMS: We explored whether, how and why moving onto and using a hybrid day-and-night closed-loop system affected people's food choices and dietary practices to better understand the impact of this technology on everyday life and inform recommendations for training and support given to future users. METHODS: Twenty-four adults, adolescents and parents were interviewed before commencing use of the closed-loop system and following its 3-month use. Data were analysed thematically and longitudinally. RESULTS: While participants described preparing and/or eating similar meals to those consumed prior to using a closed-loop, many described feeling more normal and less burdened by diabetes in dietary situations. Individuals also noted how the use of this technology could lead to deskilling (less precise carbohydrate counting) and less healthy eating (increased snacking and portion sizes and consumption of fatty, energy-dense foods) because of the perceived ability of the system to deal with errors in carbohydrate counting and address small rises in blood glucose without a corrective dose needing to be administered. CONCLUSIONS: While there may be quality-of-life benefits to using a closed-loop, individuals might benefit from additional nutritional and behavioural education to help promote healthy eating. Refresher training in carbohydrate counting may also be necessary to help ensure that users are able to undertake diabetes management in situations where the technology might fail or that they take a break from using it.

Assessment of family functioning in families with a child diagnosed with type 1 diabetes: Validation and clinical relevance of the general functioning subscale of the McMaster family assessment device.

BACKGROUND: Type 1 diabetes (T1D) can have a negative effect on family functioning, which is associated with deterioration in metabolic control. Therefore, a valid tool for assessing family functioning is clinically relevant. We assessed the quality and validity of the Danish general functioning (GF) subscale of the family assessment device (FAD). Additionally, we investigated GF scores among adolescents with T1D and their parents and the relationship between family functioning and background variables, including metabolic control. METHODS: All Danish families with a child diagnosed with T1D (N = 1997) were invited to participate in a web-based survey. In total, 616 adolescents (aged 12-17 years) and 1035 parents (of children aged 2-17 years) responded. The quality and validity of measurements made using the GF subscale were assessed using the Rasch model and graphical log-linear Rasch models (GLLRMs). Differences among GF responses were also assessed using GLLRMs. The relationships between GF scores and background variables were examined by multivariate analyses. RESULTS: A dichotomized version of the GF subscale provided essentially valid measures of family functioning. Furthermore, the GF subscale measured family functioning most accurately in families with worse family functioning than in our population. To accurately characterize family functioning, it is important to take both parent's and adolescent's perceptions into account. Family functioning was associated with glycated hemoglobin (HbA1c) levels, and discrepancies in family functioning were associated with higher HbA1c levels. CONCLUSIONS: A dichotomized GF subscale is useful for assessment of family functioning. Parent's and adolescent's scores should be kept separate. Family functioning is associated with HbA1c levels.

Disparities in Insulin Pump Therapy Persist in Youth With Type 1 Diabetes Despite Rising Overall Pump Use Rates.

PURPOSE: This study sought to determine if disparities in insulin pump therapy among youth with type 1 diabetes (T1DM) persist despite recent increases in overall pump use rates. DESIGN AND METHODS: All patients aged 6 months-17 years, diagnosed with T1DM, and completed 4+ outpatient diabetes visits at an academically-affiliated pediatric health care center from 2011 to 2016 were identified (n = 2131). Data were collected from existing electronic medical records and a multivariable logistic regression model was used to identify factors associated with insulin pump therapy. RESULTS: Findings revealed one novel factor (patients/families whose primary language is Spanish [OR 0.47, p = 0.038] or other non-English languages [OR 0.47, p = 0.028]) and confirmed several previously known factors associated with lower insulin pump use: patients who were older (10-14 years OR 0.38, p < 0.0001; 15+ years OR 0.15, p < 0.0001), male (OR 0.80, p = 0.021), non-Hispanic black (OR 0.59, p = 0.009), American Indian/Alaska Native (OR 0.19, p = 0.023), had either government (OR 0.42, p < 0.0001) or no insurance (OR 0.52, p = 0.004) and poor glycemic control (at least one HbA1c ≥ 8.5%; OR 0.54, p < 0.0001). CONCLUSION: Significant disparities in insulin pump use in youth with T1DM persist despite known benefits associated with pump therapy and underlying causes remain unclear. PRACTICE IMPLICATIONS: Health care providers should explore barriers to insulin pump therapy, including limited English language proficiency.

Near-Continuous Glucose Monitoring Makes Glycemic Control Safer in ICU Patients.

OBJECTIVES: Tight glycemic control using intermittent blood glucose measurements is associated with a risk of hypoglycemia. Glucose concentrations can now be measured near continuously (every 5-15 min). We assessed the quality and safety of glycemic control guided by a near-continuous glucose monitoring system in ICU patients. DESIGN: Prospective, cluster-randomized, crossover study. SETTING: Thirty-five-bed medico-surgical department of intensive care with four separate ICUs. PATIENTS: Adult patients admitted to the department and expected to stay for at least 3 days were considered for inclusion if they had persistent hyperglycemia (blood glucose > 150 mg/dL) up to 6 hours after admission and/or were receiving insulin therapy. INTERVENTIONS: A peripheral venous catheter was inserted in all patients and connected to a continuous glucose monitoring sensor (GlucoClear; Edwards Lifesciences, Irvine, CA). The four ICUs were randomized in pairs in a crossover design to glycemic control using unblinded or blinded continuous glucose monitoring monitors. The insulin infusion rate was adjusted to keep blood glucose between 90 and 150 mg/dL using the blood glucose values displayed on the continuous glucose monitor (continuous glucose monitoring group-unblinded units) or according to intermittent blood glucose readings (intermittent glucose monitoring group-blinded units). MEASUREMENTS AND MAIN RESULTS: The quality and safety of glycemic control were assessed using the proportion of time in range, the frequency of blood glucose less than 70 mg/dL, and the time spent with blood glucose less than 70 mg/dL (TB70), using blood glucose values measured by the continuous glucose monitoring device. Seventy-seven patients were enrolled: 39 in the continuous glucose monitoring group and 38 in the intermittent glucose monitoring group. A total of 43,107 blood glucose values were recorded. The time in range was similar in the two groups. The incidence of hypoglycemia (8/39 [20.5%] vs 15/38 [39.5%]) and the TB70 (0.4% ± 0.9% vs 1.6% ± 3.4%; p < 0.05) was lower in the continuous glucose monitoring than in the intermittent glucose monitoring group. CONCLUSIONS: Use of a continuous glucose monitoring-based strategy decreased the incidence and severity of hypoglycemia, thus improving the safety of glycemic control.

High frequencies of dermatological complications in children using insulin pumps or sensors.

BACKGROUND: Dermatological complications in children and adolescents that are related to continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) have not been well-characterized. This study examined the prevalence and characteristics of different types of dermatological complications. METHODS: Online questionnaires regarding dermatological complications related to CSII and/or CGM were returned from a total of 144 children and adolescents, aged 2 to 20 years. Both previous and current skin problems were reported along with their clinical characteristics. Descriptive statistics, χ2 tests, and multivariate analyses were used to evaluate the data. RESULTS: Of 143 patients using CSII, 90% had previous and 63% reported current dermatological complications. Non-specific eczema was most frequently reported and was currently present in 25.7% of the patients. These results were independent of age and current CGM use. Among the 76 patients using CGM, 46% reported current dermatological complications. A history of atopy was associated with dermatological complications in individuals using CSII, but not CGM. The patients rated CGM-related dermal issues as significantly worse than those associated with CSII (P < .05). CONCLUSIONS: Dermatological complications can be a serious problem in treating pediatric and adolescent patients of all ages with CSII and/or CGM. Only a few clinical characteristics associated with these complications were identified in this study, highlighting the need for prospective studies that might lead to improvements in the prevention and treatment of dermatological problems.

Mealtime insulin bolus adherence and glycemic control in adolescents on insulin pump therapy.

Poor self-management contributes to insufficient glycemic control in adolescents with type 1 diabetes (T1DM). We assessed the effects on glycemic control of adherence to self-measurement of blood glucose (SMBG) and insulin boluses in 90 adolescents with T1DM on insulin pump therapy over a 2-month period. We compared the number of insulin boluses and SMBGs around main meals to the "gold standard" of optimal diabetes management (SMBGs and a bolus before each main meal and SMBG before bedtime). The mean (95% CI) HbA1c levels were 2.9(1.7 to 4.0) mmol/mol lower for every additional insulin bolus and 3.1(1.6 to 4.5) mmol/mol lower for every additional SMBG. Patients performing SMBG and bolusing around each main meal had considerably lower HbA1c levels than those unable to do (95% CI for difference 4.3 to 10.4 mmol/mol and 11.5 to 20.1 mmol/mol respectively). For each additional mealtime bolus/day, the odds ratio of achieving target HbA1c levels of <58 mmol/mol was 6.73 (95% CI 2.94-15.38), after adjustment for gender, age, diabetes duration, and affective responses to SMBG in a multiple logistic regression model.Conclusion: Glycemic control in adolescents with T1DM on insulin pump therapy is strongly dependent on adherence to insulin boluses around mealtimes. What is Known: • In mixed groups of children and adolescents, insulin bolus frequency and self-monitoring of blood glucose (SMBG) frequency were determinants of HbA1c levels. • Adherence to insulin boluses and SMBG is particularly challenging in adolescents. What is New: • In adolescents on insulin pump therapy, each additional insulin bolus, particularly around mealtime, was significantly associated with approximately 3 mmol/mol lower HbA1c levels. • This beneficial effect of mealtime bolusing was strongest for the evening meal.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY 2018 POSITION STATEMENT ON INTEGRATION OF INSULIN PUMPS AND CONTINUOUS GLUCOSE MONITORING IN PATIENTS WITH DIABETES MELLITUS.

This document represents the official position of the American Association of Clinical Endocrinologists and American College of Endocrinology. Where there are no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician. AACE/ACE Task Force on Integration of Insulin Pumps and Continuous Glucose Monitoring in the Management of Patients With Diabetes Mellitus Chair George Grunberger, MD, FACP, FACE Task Force Members Yehuda Handelsman, MD, FACP, FNLA, MACE Zachary T. Bloomgarden, MD, MACE Vivian A. Fonseca, MD, FACE Alan J. Garber, MD, PhD, FACE Richard A. Haas, MD, FACE Victor L. Roberts, MD, MBA, FACP, FACE Guillermo E. Umpierrez, MD, CDE, FACP, FACE Abbreviations: AACE = American Association of Clinical Endocrinologists ACE = American College of Endocrinology A1C = glycated hemoglobin BGM = blood glucose monitoring CGM = continuous glucose monitoring CSII = continuous subcutaneous insulin infusion DM = diabetes mellitus FDA = Food & Drug Administration MDI = multiple daily injections T1DM = type 1 diabetes mellitus T2DM = type 2 diabetes mellitus SAP = sensor-augmented pump SMBG = self-monitoring of blood glucose STAR 3 = Sensor-Augmented Pump Therapy for A1C Reduction phase 3 trial.