Explore alarm signals cited in insulin pump-associated adverse events (AEs), describe the clinical consequences and other root cause informing remarks that cooccurred with the alarm signals, and ...identify opportunities for improvements to patient education, instructional materials, and alarm systems to prevent future AEs.
We explored the type, frequency, and associated clinical consequences of alarm signals cited in a pre-coded data set of 2294 insulin pump-associated AEs involving the MiniMed 670G, MiniMed 630G, and t:slim X2. We also explored the clinical consequences and other root cause informing remarks that cooccurred with the top 10 most frequently cited alarm signals.
Overall, 403 AEs narratives cited at least one alarm signal. Of the 40 unique alarm signals cited, 42.5% were "alarms," 25.0% were "alerts," and 32.5% were not referenced in the instructional materials packaged with the corresponding pump. The top 10 most frequently cited alarm signals included two obstruction of flow alarms, which accounted for 49.9% of all AEs citing at least one alarm, and two unreferenced alarms. The most frequent cooccurring root cause informing remark varied across the top 10 alarm signals and revealed valuable insight into why these alarms may have occurred.
Our findings demonstrate the value of analyzing alarm signals cited in insulin pump-associated AEs and reveal multiple opportunities for providers to educate patients on how to respond to alarm signals and manage their pumps to avoid AEs, and for insulin pump manufacturers to update instructional materials and improve alarm systems to support appropriate patient response.
To explore the clinical consequences and potential root causes of insulin pump-associated adverse events (AEs) reported in the Food and Drug Administration's Manufacturer and User Facility Device ...Experience (MAUDE) database.
Qualitative template analysis of narrative data in a 20% stratified random sample (
= 2429) of reported AEs that occurred during the first 6 months of 2020 involving five insulin pump models marketed at that time: (1) MiniMed™ 670G, (2) MiniMed™ 630G, (3) Omnipod
, (4) Omnipod DASH
, and (5) t:slim X2™.
Of the 2429 AEs, 92% included a clinical consequence in the narrative description, with critical hyperglycemia (i.e., blood glucose BG >400 mg/dL; 47%) and critical hypoglycemia (i.e., BG <54 mg/dL; 24%) being the most common consequence cited. Only 50% of the AE narratives included information to support the identification of a root cause. The most cited root cause informing remarks were issues with the pump or pod reservoir/cartridge (9%), the occurrence of an obstruction of flow alarm (8%), and problems with the infusion set or site (8%). Some clinical consequences and root cause informing remarks were cited more frequently in AE narratives involving specific insulin pump models, but manufacturer variability in the amount and type of information reported may have affected these findings.
Our findings show general themes found in insulin pump-associated AE that providers can use to raise patient awareness of potential risks associated with insulin pump use and develop strategies to prevent future AEs. Improvements in AE investigation and reporting processes are still necessary.
To document the prevalence of skin problems associated with insulin pump use and identify contributing factors among children with type 1 diabetes mellitus in China.
In total, 461 children were ...recruited from an online community (i.e., a Wechat group) of pediatric patients with T1DM. A self-developed questionnaire was filled in by parents, collecting the information on social demographics, disease, and insulin pump therapy related characteristics and skin problems. We applied the Mann–Whitney U test, Chi square test and logistic regression analysis to identify the factors associated with skin problems.
Of the 461 responders, 308 (66.8 %) children were reported to have skin problems. More specifically, 38.8 % had pigmentation changes, 22.3 % allergy/dermatitis, 20.2 % scaring, 11.5 % pain, 10.8 % infection, 10.6 % subcutaneous lipohypertrophy, and 6.1 % lipoatrophy. Logistic regression analysis showed that independent associated factors of skin problems were the caregiver’s educational level as college or above, patient having skin allergies, and using the Brand 2 insulin pump (p values < 0.05).
The present study documents the prevalence of skin problems and identifies associated factors, such as caregiver’s education, patients skin allergies, and using a specific brand of pump. Health education should address these factors in addition to the traditionally emphasized factors.
Aims/hypothesis
The aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitoring (CGM) to insulin pump therapy (CSII) in type ...1 diabetes.
Methods
Children and adults (
n
= 153) on CSII with HbA
1c
7.5–9.5% (58.5–80.3 mmol/mol) were randomised to (CGM) a Sensor On or Sensor Off arm for 6 months. After 4 months’ washout, participants crossed over to the other arm for 6 months. Paediatric and adult participants were separately electronically randomised through the case report form according to a predefined randomisation sequence in eight secondary and tertiary centres. The primary outcome was the difference in HbA
1c
levels between arms after 6 months.
Results
Seventy-seven participants were randomised to the On/Off sequence and 76 to the Off/On sequence; all were included in the primary analysis. The mean difference in HbA
1c
was –0.43% (–4.74 mmol/mol) in favour of the Sensor On arm (8.04% 64.34 mmol/mol vs 8.47% 69.08 mmol/mol; 95% CI −0.32%, −0.55% −3.50, −6.01 mmol/mol;
p
< 0.001). Following cessation of glucose sensing, HbA
1c
reverted to baseline levels. Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day;
p
= 0.009). The mean number of daily boluses increased in the Sensor On arm (6.8 ± 2.5 vs 5.8 ± 1.9,
p
< 0.0001), together with the frequency of use of the temporary basal rate (0.75 ± 1.11 vs 0.26 ± 0.47,
p
< 0.0001) and manual insulin suspend (0.91 ± 1.25 vs 0.70 ± 0.75,
p
< 0.018) functions. Four vs two events of severe hypoglycaemia occurred in the Sensor On and Sensor Off arm, respectively (
p
= 0.40).
Conclusions/interpretation
Continuous glucose monitoring was associated with decreased HbA
1c
levels and time spent in hypoglycaemia in individuals with type 1 diabetes using CSII. More frequent self-adjustments of insulin therapy may have contributed to these effects.
Trial registration
ClinicalTrials.gov registration no. NCT00598663.
Funding
The study was funded by Medtronic International Trading Sarl Switzerland.
Background:
Recent development of automated closed-loop (CL) insulin delivery systems, the so-called artificial pancreas (AP), improved the quality of type 1 diabetes (T1D) therapy. As new ...technologies emerge, patients put increasing trust in their therapeutic devices; therefore, it becomes increasingly important to detect malfunctioning affecting such devices. In this work, we explore a new paradigm to detect insulin pump faults (IPFs) that use unsupervised anomaly detection.
Methods:
We generated CL data corrupted with IPFs using the latest version of the T1D Padova/UVA simulator. From the data, we extracted several features capable to describe the patient dynamics and making more apparent suspicious data portions. Then, a feature selection is performed to determine the optimal feature set. Finally, the performance of several popular unsupervised anomaly detection algorithms is analyzed and compared on the identified optimal feature set.
Results:
Using the identified optimal configuration, the best performance is obtained by the Histogram-Based Outlier Score (HBOS) algorithm, which detected 87% of the IPF with only 0.08 false positives per day on average. Isolation forest is the best algorithm that offers more conservative performances, detection of 85% of the faults but only 0.06 false positives per day on average.
Conclusion:
Unsupervised anomaly detection algorithms can be used effectively to detect IPFs and improve the safety of the AP. Future studies will be dedicated to test the presented method inside dedicated clinical trials.
Background:
Psychosocial impact research of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) among adolescents with type 1 diabetes (T1D) is limited. The ...present study assesses associations between diabetes technology use on adolescent- and parent-perceived diabetes-specific distress and A1c.
Method:
Adolescents with T1D and parents (N = 1040; primarily mothers) completed measures of diabetes distress. Adolescents were categorized by technology use: CGM Alone, CSII Alone, CGM+CSII, or No Technology. ANOVA, regression, and Cohen’s d were used for group comparisons on measures of diabetes distress and A1c. Analyses also compared groups on clinical elevations of distress.
Results:
CGM use was associated with less adolescent distress compared to No Technology (d = 0.59), CGM+CSII (d = 0.26), and CSII Alone (d = 0.29). Results were similar but with smaller effect size for parent-reported distress, although CGM+CSII showed equivocal association with parent distress compared to No Technology (d = 0.18). CGM Alone was associated with lower A1c compared to No Technology (d = 0.48), to CSII Alone (d = 0.37), and was comparable to CGM+CSII (d = 0.03). CGM+CSII conferred advantage over CSII Alone (d = 0.34). Clinical elevation of distress was associated with not using any technology particularly for adolescents.
Conclusions:
Technology use is associated with lower adolescent distress than lower parent distress. CGM Alone is associated with lower adolescent and parent distress than CSII or CGM+CSII. This appears to be clinically meaningful based on cut scores for measures. CGM is associated with lower A1c independent of being used alone or with CSII.
Abstract. Continuous subcutaneous insulin infusion (CSII) therapy using insulin pumps has become widely used in the treatment of type 1 diabetes mellitus (T1DM). This retrospective study aimed to ...assess the efficacy and safety of long-term insulin pump treatment in patients with T1DM aged >=50 years. The study included patients aged >=50 years, who had a diagnosis of T1DM based on clinical criteria and/or presence of autoantibodies characteristic of autoimmune diabetes, and had received >=5 years of recent and uninterrupted treatment with a personal insulin pump. We analyzed records on HbA1c levels across the entire observation period. The cohort comprised 17 patients, of whom 6 (35%) were men and 11 (65%) were women. The mean duration of observation was 6.6 years, during which patients had a mean of 8.4 HbA1c measurements. Mean HbA1c level over the entire observation period was 6.7% (range, 5.3-7.4%). Overall, 11 patients (65%) had mean HbA1c levels at the ADA-recommended target of <7% and 5 patients (29%) had mean HbA1c <6.5%. Mean HbA1c level was significantly lower at the end of the observation period than at the start (6.52% versus 6.91%; difference, -0.39%; p<0.01), indicating an improvement in glycaemic control over time. On average, patients experienced one level 1 hypoglycaemia episode every 2.4 days. This retrospective analysis of at least 5 years of follow-up of selected patients with T1DM aged >=50 years at the start of observation, showed that CSII is a safe and effective treatment option in this age group.
Continuous subcutaneous insulin infusion (CSII) therapy using insulin pumps has become widely used in the treatment of type 1 diabetes mellitus (T1DM). This retrospective study aimed to assess the ...efficacy and safety of long-term insulin pump treatment in patients with T1DM aged ≥50 years. The study included patients aged ≥50 years, who had a diagnosis of T1DM based on clinical criteria and/or presence of autoantibodies characteristic of autoimmune diabetes, and had received ≥5 years of recent and uninterrupted treatment with a personal insulin pump. We analyzed records on HbA1c levels across the entire observation period. The cohort comprised 17 patients, of whom 6 (35%) were men and 11 (65%) were women. The mean duration of observation was 6.6 years, during which patients had a mean of 8.4 HbA1c measurements. Mean HbA1c level over the entire observation period was 6.7% (range, 5.3–7.4%). Overall, 11 patients (65%) had mean HbA1c levels at the ADA-recommended target of <7% and 5 patients (29%) had mean HbA1c <6.5%. Mean HbA1c level was significantly lower at the end of the observation period than at the start (6.52% versus 6.91%; difference, –0.39%; p < 0.01), indicating an improvement in glycaemic control over time. On average, patients experienced one level 1 hypoglycaemia episode every 2.4 days. This retrospective analysis of at least 5 years of follow-up of selected patients with T1DM aged ≥50 years at the start of observation, showed that CSII is a safe and effective treatment option in this age group.
To evaluate the impact of temporary insulin pump use during hospitalization on glycemia, postoperative complications, and cost/utilization in perioperative patients with diabetes.
Patients (n=159) ...with type 2 diabetes and hospitalized for elective surgery were recruited from three hospitals. Subjects were categorized into the insulin pump group and the multiple daily subcutaneous insulin injection group according to their treatment therapy. Data were collected at admission, discharge, and 3 months post-discharge.
Subjects in the CSII group who were still on insulin therapy transitioned from CSII to MDII; however, their daily insulin dosages were lower than those in the MDII group (15.31±10.98 U/d vs. 23.48±17.02 U/d, P=0.015) after discharge. In terms of medical costs, the CSII group had significantly higher hospitalization costs than the MDII group (112.36±103.43 thousand RMB vs. 82.65±77.98 thousand RMB, P=0.043). After 3 months, the CSII group had significantly lower outpatient costs than the MDII group (3.17±0.94 thousand RMB vs. 3.98±1.76 thousand RMB, P ˂ 0.001). In the MDII group, 10 patients reported severe postoperative complications requiring re-hospitalization; there were no similar reports in the CSII group.
Temporary use of insulin pump therapy for perioperative patients with diabetes results in a reduction in blood glucose and blood glucose fluctuation during hospitalization, HbA1c, and the risk of postoperative complication and readmission, thus significantly decreasing costs in this complex patient cohort. Further work is needed to better understand indications for utilizing pump therapy based on diabetes phenotype and the complexity of planned surgical intervention.
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