Positive impacts of changes to a tertiary hospital after-hours endocrine and diabetes on-call service.

AIM: To examine the impact of changes to the endocrine/diabetes after-hours service model of care at a major tertiary children's hospital in Australia. The model aimed to enhance the independence of families and reduce dependency on after-hours calls to health professionals. METHODS: The after-hours activity was captured prospectively using an iPad with a customised FileMaker database. Data were collected for 9 months prior to and for 8 months after the implementation of a modified model of service. Questionnaires gathered information from endocrine junior medical officers (JMOs) and other hospital staff. Data on emergency department visits were analysed for presentations before and after the implementation of the service changes. RESULTS: Changes to the after-hours service resulted in a significant reduction in median calls from 9 (range 0-39) to 2 (range 0-7) per shift. The number of shifts with no calls increased from 2 to 24% and the number of shifts with <3 calls increased from 8 to 60%. Disturbed nights (calls between 10 pm and 6 am) decreased from 75 to 29%. Junior medical officer experience was positive and there was no perceivable increase in workload from in-hospital staff. The number of endocrine patients presenting to the emergency department did not change significantly following the implementation of the new after-hours service. CONCLUSION: This is the only Australian study to prospectively gather accurate on-call data in order to elucidate the impact of changing a hospital's after-hours endocrine/diabetes service to a model that enhanced family empowerment and independence. Historical 24-h on-call service models are not indispensable, and changes can improve sustainability without compromising patient care.

Unexpected Management Behaviors in Adolescents With Type 1 Diabetes Using Sensor-Augmented Pump Therapy.

BACKGROUND: Continuous glucose monitoring can improve glycemic outcomes in individuals with type 1 diabetes. However, the constant exposure to real-time glucose levels can sometimes lead the individual to make some risky choices to address the glycemic excursions. Hence, the purpose of this study was to explore the aberrant management behaviors of youth with type 1 diabetes on sensor-augmented pump therapy (SAPT). METHODS: Participants in a clinical trial using SAPT on Medtronic MiniMed™ 640G pump who experienced deteriorating glycemic control or unexplained hypoglycemia were identified by the health care professional. The pump and/or sensor data uploaded to CareLink™ Therapy Management Software were reviewed in these participants. RESULTS: Uncharacteristic management behaviors were identified in five adolescent males. Continuous exposure to high glucose levels resulted in obsessive behaviors displaying a perfectionistic attitude in two participants. Multiple boluses were delivered frequently as uneaten carbohydrates in participant 1 while participant 2 resorted to delivery of extra insulin by cannula fills. In contrast, participant 3 chose to remain hyperglycemic to avoid weight gain while participant 4 trusted the system and used sensor glucose readings for calibrations, with resultant deterioration in glycemic control in both participants. On the other hand, participant 5, due to mistrust in the pump suspend function, consumed carbohydrates with downward glucose trends with rebound hyperglycemia. CONCLUSIONS: Constant exposure to real-time data can lead to unsafe management responses in adolescents with the behavior influenced by trust or mistrust in the system. Adolescents should be empowered with problem-solving strategies for safe management.

Prevention of Insulin-Induced Hypoglycemia in Type 1 Diabetes with Predictive Low Glucose Management System.

BACKGROUND: Sensor-augmented pump therapy (SAPT) with algorithms to predict impending low blood glucose and suspend insulin delivery has the potential to reduce hypoglycemia exposure. The aim of this study was to determine whether predictive low glucose management (PLGM) system is effective in preventing insulin-induced hypoglycemia in controlled experiments. METHODS: Two protocols were used to induce hypoglycemia in an in-clinic environment. (A) Insulin bolus: Insulin was administered as a manual bolus through the pump. (B) Increased basal insulin: Hypoglycemia was induced by increasing basal rates overnight to 180%. For both protocols, participants were randomized and studied on 2 separate days; a control day with SAPT alone and an intervention day with SAPT and PLGM activated. The predictive algorithm was programmed to suspend basal insulin infusion when sensor glucose was predicted to be <80 mg/dL in 30 min. The primary outcome was the requirement for hypoglycemia treatment (symptomatic hypoglycemia or plasma glucose <50 mg/dL) and was compared in both control and intervention arms. RESULTS: With insulin bolus, 24/28 participants required hypoglycemia treatment with SAPT alone compared to 5/28 participants when PLGM was activated (P ≤ 0.001). With increased basal rates, all the eight SAPT-alone participants required treatment for hypoglycemia compared to only one with SAPT and PLGM. There was no post pump-suspend hyperglycemia with insulin bolus (P = 0.4) or increased basal rates (P = 0.69) in participants with 2-h pump suspension on intervention days. CONCLUSIONS: SAPT with PLGM reduced the requirement for hypoglycemia treatment following insulin-induced hypoglycemia in an in-clinic setting.

Analysis of insulin pump settings in children and adolescents with type 1 diabetes mellitus.

AIM: To characterize current insulin pump settings used in young patients with type 1 diabetes mellitus (T1DM) and to assess their relationship to glycemic control. METHODS: This retrospective study included patients aged <18 yr old with T1DM >1 yr using a Medtronic pump device. Pump data including number of blood glucose (BG) tests per day, basal and bolus insulin parameters, carbohydrate ratio (CR), and insulin sensitivity factors (ISFs) were averaged over 14 d for statistical analyses. Anthropometric data and recent glycosylated hemoglobin A1c (HbA1c) were recorded. RESULTS: A total of 292 patients (144 males and 148 females) were included in the study. Participants had a median age (interquartile range, IQR) of 12.9 yr (10.0-15.1 yr) and pump duration of 2.8 yr (1.5-4.2 yr). No significant differences in median HbA1c (IQR) were observed in preschool [n = 14; HbA1c 7.8% (7.3-8.3%)], prepubertal [n = 105; HbA1c 8.1% (7.7-8.9%)], and adolescent subjects [n = 173; HbA1c 8.4% (7.7-9.0%)]. Adolescents took significantly fewer boluses and BG tests per day compared with younger children (p < 0.05). Age-specific diurnal variation in basal insulin delivery was noted. Additionally, stronger carbohydrate cover and weaker corrections were used in real-life compared with theoretical 500 and 100 rules, respectively. Lower HbA1c was associated with higher number of daily boluses, greater number of BG tests per day, lower average CR/500 rule ratio, and higher average ISF/100 rule ratio adjusted for age (R(2) = 0.22; p < 0.01). CONCLUSION: Insulin pump therapy requires continuous adjustments and glycemic targets are achieved by a minority. We believe this is the first study in pediatric cohort looking at association between CR and ISF with glycemic control.

Insulin pump-associated adverse events in children and adolescents--a prospective study.

BACKGROUND: Intensive insulin regimens are now the mainstay of modern, type 1 diabetes mellitus management. Insulin pumps (CSII) are a key technique used. Although there has been considerable study of outcomes, there are few recent data on CSII-associated adverse events (AEs) and their incidence and characteristics. SUBJECTS AND METHODS: Phone calls to our 24-h diabetes support service were screened for CSII-associated AEs. Phone interviews were conducted with the parent/patient, within 96 h of the event. Interviews explored AE characteristics and the role of the user, as well as questions relating to outcome and the impact to the family and patient. Comparisons were made with clinic CSII patients not reporting an AE. RESULTS: Over a 16-week study period, 50 confirmed AEs occurred in 45 of 405 (11.1%) patients. This was annualized to an AE incidence of 40 AEs/100 person-years. Pump malfunction and infusion set/site failures were the most common events reported, occurring in 27 (54.0%) and 18 (36.0%) AEs, respectively. A user- or education-related issue was implicated in 22 (44.0%) events. Pump replacement occurred in 19 of 50 occurrences (38.0%). Additionally, 16 (32.0%) reported a hospital admission or emergency department attendance as a consequence. When compared with those on CSII not reporting an AE, AEs were associated with age <10 years (odds ratio=3.2 [95% confidence interval, 1.7-6.1]) but not with gender, glycosylated hemoglobin, diabetes duration, or pumping duration. CONCLUSIONS: This is the first prospective study to look at AEs in modern-generation insulin pumps. AEs appear common and should be anticipated. Their origin is multifactorial, with the pump, associated consumables, and the user all being important factors. Ongoing support and anticipatory education are essential to minimize pump-associated AEs and their impact.

Family perceptions of insulin pump adverse events in children and adolescents.

BACKGROUND: Insulin pumps (for continuous subcutaneous insulin infusion [CSII]) are used widely in type 1 diabetes mellitus. Although there has been considerable study of outcomes, there are few recent data on CSII-associated adverse events and no data on family perceptions of adverse events and their confidence in dealing with them. SUBJECTS AND METHODS: We approached all families of children and adolescents ≤ 19 years of age on CSII attending the diabetes clinic over a 16-week clinic cycle. Participants completed a retrospective questionnaire examining issues over the previous 12 months. Data on pump adverse events as well as answers to questions pertaining to education and confidence were collected. RESULTS: Our survey received a response rate of 99%, with 235 of the 238 families approached participating. In the preceding 12 months, 104 of 230 (45%) had reported at least one pump-related adverse event (either mechanical or set-related), with an associated 52 of 229 (23%) resulting in pump replacement. This equated to a minimum incidence density of 53 adverse events/100 person-years. Additionally, 18 of 230 (8%) reported a hospital admission or emergency department attendance as a consequence. Pump malfunction and infusion set/site failures were the most common events reported, with one or more events in 58 of 104 (56%) and 47 of 104 (45%), respectively. Adverse events, excluding set/site failures, were associated with older age (13.1 ± 3.4 years vs. 11.9 ± 4 years; P = 0.02). CONCLUSIONS: This is the first study to look at family perceptions of adverse events while using modern CSII. It highlights a high self-reported rate of CSII-related adverse events, pump replacement, and subsequent presentation to the hospital. Potential areas for additional targeted education are identified. Further prospective study examining pump adverse event characteristics and incidence is warranted.