Improving equity in diabetes technology use: Voices of youth and their parents.

AIMS: There are marked inequities in clinical outcomes and rates of diabetes technology use among youth with type 1 diabetes (T1D). The quantitative data from our mixed methods cohort study identified significant improvements in glycaemia and quality of life in participants. We aimed to use qualitative methods to provide further insight into our quantitative findings in the setting of underlying health disparities. METHODS: Fifteen publicly insured, insulin pump-naïve non-Hispanic Black youth aged 6-21 years with T1D and baseline haemoglobin A1c (HbA1c) ≥86 mmol/mol (10%) and their parents participated in a mixed methods cohort study. Semi-structured interviews were conducted separately with parents and youth after completion of 6 months of HCL use. Three topic areas were explored: (1) Experience using HCL, (2) barriers to HCL and (3) facilitators to accessing HCL. Semantic content analysis and consensus coding involving two team members were used to generate themes. Thematic saturation was achieved. RESULTS: Youth (Medianage 14.9 years, 67% female) and parents (92% female) were interviewed. Youth and their parents reported that access to HCL provides a new outlook on living with T1D, although managing T1D is still hard. They felt that diabetes technology is most helpful for those struggling with management. Participants experienced barriers to access including misconceptions of HCL systems, clinician bias and systemic racism. They suggested these barriers can be overcome by offering diabetes technology education for all people with T1D, increasing awareness of HCL in the community and providing resources to overcome barriers created by social determinants of health. CONCLUSIONS: The voices of historically minoritised youth with suboptimal T1D control and their parents provide important, previously unreported experiences and perspectives on barriers and facilitators to using HCL that will shape interventions to improve equity in access to diabetes technology.

Real-world glycaemic outcomes of automated insulin delivery in type 1 diabetes: A meta-analysis.

AIM: To evaluate the real-world effectiveness of automated insulin delivery (AID) systems in patients with type 1 diabetes (T1D). MATERIALS AND METHODS: PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched for studies published up until 2 March 2024. We included pragmatic randomized controlled trials (RCTs), cohort studies, and before-after studies that compared AID systems with conventional insulin therapy in real-world settings and reported continuous glucose monitoring outcomes. Percent time in range (TIR; 3.9-10 mmol/L), time below range (TBR; <3.9 mmol/L), time above range (TAR; >10 mmol/L), and glycated haemoglobin (HbA1c) level were extracted. Data were summarized as mean differences (MDs) with 95% confidence interval. RESULTS: A total of 23 before-after studies (101 704 participants) were included in the meta-analysis. AID systems were associated with an increased percentage of TIR (11.61%, 10.47 to 12.76; p < 0.001). The favourable effect of AID systems was consistently observed when used continuously for 6 (11.76%) or 12 months (11.33%), and in both children (12.16%) and adults (11.04%). AID systems also showed favourable effects on TBR (-0.53%, -0.63 to -0.42), TAR (-9.65%, -10.63 to -8.67) and HbA1c level (-0.42%, -0.47 to -0.37) when compared with previous treatments. CONCLUSIONS: Similar improvements in glycaemic parameters were observed in real-world settings in RCTs using AID systems in T1D. AID systems benefit both children and adults by increasing TIR for both short- and long-term interventions.

Insulin Pump Therapy and Adverse Skin Reactions With Focus on Allergic Contact Dermatitis in Individuals Living With Diabetes Mellitus: A Systematic Review and Clinical-Based Update.

BACKGROUND: The use of insulin pumps (continuous subcutaneous insulin infusion [CSII]) in individuals living with type 1 diabetes (T1D) improves disease control. However, adverse skin reactions may hamper compliance. We aimed to assess the relationship of insulin pumps, particularly that of infusion set therapy, used in children and adults with T1D and dermatitis including allergic contact dermatitis (ACD). METHODS: A systematic search of PubMed, and EMBASE, of full-text studies reporting dermatitis in persons with diabetes using a CSII was conducted from 2020 to 2023. The Newcastle-Ottawa Scale was used to assess study quality. The inventory performed at the Department of Occupational and Environmental Dermatology, Malmö, Sweden (YMDA) was also performed highlighting the diagnostic process. RESULTS: Among the 391 screened abstracts, 21 studies fulfilled the inclusion criteria. Seven studies included data on children only, four studies were on adults, and nine studies reported data on both children and adults. Participants were exposed to a broad range of pumps. Dermatitis was rarely specified. Up to 60% of those referred to a university hospital due to skin reactions possibly related to insulin pumps had an ACD. CONCLUSIONS: The review and our findings indicate that there is not sufficient focus on contact allergy in the primary toxicological evaluations of substances used also for insulin pump therapy products and that possible adverse skin reactions are not correctly followed up in the clinical setting.

Insights into the Feasibility and Acceptability of a Mobile Insulin Titration Application in Clinical Practice and Its Effects on Diabetes Outcomes.

Introduction: Insulin therapy is most effective if patients learn how to properly adjust insulin to achieve glycaemic targets. There is a need for methods and tools that can assist these processes in clinical practice. The purpose of this feasibility study was to evaluate an approach to support insulin dose adjustment in individual patients using a mobile titration application (app). Methods: A cohort of adults (N=36) with type 2 diabetes with suboptimal glycaemia who were starting basal insulin self-titration were trained by a diabetes care and education specialist to use a mobile titration app to guide adjusting insulin doses. Glycaemia, diabetes distress and patient and provider satisfaction were assessed during the first 3 months after initiating basal insulin titration using the mobile app. Results: Mean haemoglobin type A1c (HbA1c) was significantly reduced by an average of 2.1 ± 2.2% from baseline to 3 months (p<0.001). Diabetes distress significantly decreased from baseline to follow-up with scores going down (or improving) across all scales. Both patients and providers reported high levels of satisfaction and positive experiences. Conclusion: The model offers a promising solution to streamline insulin dosage adjustments to achieve specific clinical and self-management goals with high expectations for long-term benefits and warrants further investigation.

Twelve-Month Follow-up from a Randomized Controlled Trial of Simplified Meal Announcement Versus Precise Carbohydrate Counting in Adolescents with Type 1 Diabetes Using the MiniMed™ 780G Advanced Hybrid Closed-Loop System.

Background and Aims: Carbohydrate counting is a well-established tool for self-management of type 1 diabetes (T1D) and can improve glycemic control and potentially reduce long-term complication risk. However, it can also be burdensome, error-prone, and complicated for the patient. A randomized controlled trial was conducted to investigate glycemic control with carbohydrate counting ("flex") versus simplified meal announcement ("fix") in adolescents with T1D using the MiniMed™ 780G system. The present study reports follow-up data to 12 months. Methods: Adolescents with T1D were randomly assigned 1:1 to use the MiniMed™ 780G system alongside the flex versus fix approaches. Participants were followed for 12 months with outcomes recorded at 3, 6, 9, and 12 months. The primary endpoint was the difference in time-in-range (TIR), and secondary endpoints included glycated hemoglobin (HbA1c) and other glucose and insulin metrics. Results: At 12 months, TIR (proportion of time with sensor glucose 70-180 mg/dL) was significantly lower in the fix versus flex group (72.9% vs. 80.1%, respectively; P = 0.001). There was no significant difference in HbA1c between the fix (6.8% ± 0.5%) and flex groups (6.5% ± 0.5%) at 12 months (P = 0.092), and mean HbA1c was below 7% at all time points in both arms. Conclusions: Glycemic control with simplified meal announcement was maintained over 12 months. On average, the international consensus targets were met in both arms for all time points. The simplified approach represents a viable alternative to carbohydrate counting, particularly in people who find the latter burdensome; however, carbohydrate counting resulted in superior TIR. This study is registered with ClinicalTrials.gov, number NCT05069727.

Effects of hybrid closed-loop system on glycemic control and psychological aspects in persons with type 1 diabetes treated with sensor-augmented pump: A prospective single-center observational study.

AIMS/INTRODUCTION: This study evaluated the effects of the Medtronic MiniMed 770G hybrid closed-loop system on glycemic control and psychological aspects in persons with type 1 diabetes mellitus. MATERIALS AND METHODS: This 3-month prospective observational study included 22 participants with type 1 diabetes mellitus who used the Medtronic MiniMed 640G predictive low-glucose suspend system and were switched to the 770G system. Time in the range of 70-180 mg/dL and glycated hemoglobin levels were evaluated; satisfaction, emotional distress and quality of life were assessed using self-reported questionnaires, including the Diabetes Treatment Satisfaction Questionnaire Status, Problem Area in Diabetes and Diabetes Therapy-Related Quality of Life. RESULTS: Time in the range of 70-180 mg/dL increased (63.5 ± 13.4 to 73.0 ± 10.9% [mean ± standard deviation], P = 0.0010), and time above the range of 181-250 mg/dL decreased (26.9 ± 8.9 to 19.6 ± 7.1%, P < 0.0005). Glycated hemoglobin levels decreased (7.7 ± 1.0 to 7.2 ± 0.8%, P = 0.0021). The percentage of participants with time below the range of 54-69 mg/dL <4% of readings increased from 91% to 100% (P < 0.0005). No significant changes were detected in the satisfaction, emotional distress and quality of life levels, but increased sensor calibration might be related to worsened emotional distress and quality of life. CONCLUSIONS: The hybrid closed-loop system decreased hyperglycemia and minimized hypoglycemia, but did not improve psychological aspects compared with the predictive low-glucose suspend system, probably because sensor calibration was increased.

Error traps in the perioperative management of children with type 1 diabetes.

Patients with type 1 diabetes mellitus (T1D) require insulin administration at all times to maintain euglycemia and metabolic stability. Insulin administration in the perioperative period is complicated by fasting requirements and perioperative stressors that can change the patient's insulin needs. In addition, many anesthesia providers are not familiar with insulin dosing strategies and technology, such as insulin pumps and continuous glucose monitors (CGMs), that are commonly used by patients with T1D. Errors in perioperative insulin administration can lead to hypoglycemia, hyperglycemia, and diabetic ketoacidosis. This article reviews common errors of associated with the perioperative management of patients with T1D, including failure to assess and coordinate patient care preoperatively; failure to understand diabetes management and technology; failure to monitor blood glucose and recognize dysglycemia; and failure to appropriately administer basal insulin.

Provision of continuous subcutaneous insulin infusion to type 1 diabetes 'frequent flyers'.

A few people with type 1 diabetes undergo multiple hospital admissions for acute glycaemic events. We report on a series of five such 'frequent flyers' who were provided with continuous subcutaneous insulin infusion (CSII) therapy. Mean HbA1c decreased from 9.7 ± 2.5% (83 ± 27 mmol/mol) to 7.9 ± 0.4% (63 ± 4.7 mmol/mol) after 2-4 months. Frequency of admissions for acute glycaemic events reduced in three but increased in two patients within 6 months. Total insulin dose and body mass index decreased in some patients and satisfaction was anecdotally higher. Some, but not all, 'frequent flyers' benefited from a trial of CSII.

Perioperative maintenance of hybrid closed loop insulin pump systems in youth with type 1 diabetes mellitus: A case series.

Current guidelines support the use of continuous glucose monitoring devices and insulin pumps in minor surgical procedures for pediatric patients with type 1 diabetes mellitus. However, there are few reported cases of using hybrid closed loop technology in the perioperative period. This retrospective case series presents seven pediatric patients with type 1 diabetes who underwent eight surgical procedures with maintenance of hybrid closed loop systems. This paper also provides considerations for future use of hybrid closed loop systems perioperatively.

Type 1 Diabetes Overview and Perioperative Management.

Type 1 diabetes (T1D) is an increasingly common condition. Although often more effective, treatment regimens for patients with T1D have become more variable and complex with newer insulin analogues and increasing use of diabetes technology. Both surgery and anesthesia are known to trigger a stress response that causes dramatic metabolic changes in the patient that tend to increase glucose variability. Close monitoring of glucose levels and clear algorithms for insulin administration can ameliorate these characteristic responses. As T1D treatment technology becomes more effective at maintaining glucose in target range, there should be more consideration of using this technology during hospitalization and surgery.

Time requirements for perioperative glucose management using fully closed-loop versus standard insulin therapy: A proof-of-concept time-motion study.

AIMS: To compare the time required for perioperative glucose management using fully automated closed-loop versus standard insulin therapy. METHODS: We performed a time-motion study to quantify the time requirements for perioperative glucose management with fully closed-loop (FCL) and standard insulin therapy applied to theoretical scenarios. Following an analysis of workflows in different periods of perioperative care in elective surgery patients receiving FCL or standard insulin therapy upon hospital admission (pre- and intra-operatively, at the intermediate care unit and general wards), the time of process-specific tasks was measured by shadowing hospital staff. Each task was measured 20 times and its average duration in combination with its frequency according to guidelines was used to calculate the cumulative staff time required for blood glucose management. Cumulative time was calculated for theoretical scenarios consisting of elective minor and major abdominal surgeries (pancreatic surgery and sleeve gastrectomy, respectively) to account for the different care settings and lengths of stay. RESULTS: The FCL insulin therapy reduced the time required for perioperative glucose management compared to standard insulin therapy, across all assessed care periods and for both perioperative pathways (range 2.1-4.5). For a major abdominal surgery, total time required was 248.5 min using FCL versus 753.9 min using standard insulin therapy. For a minor abdominal surgery, total time required was 68.6 min and 133.2 min for FCL and standard insulin therapy, respectively. CONCLUSIONS: The use of fully automated closed-loop insulin delivery for inpatient glucose management has the potential to alleviate the workload of diabetes management in an environment with adequately trained staff.

High prevalence with no gender difference of likely eating disorders in type 1 mellitus diabetes on insulin pump.

AIM: The aim of this study was to determine the prevalence of likely eating disorders and insulin misuse in a prospective cohort of adults with type 1 diabetes mellitus (T1DM) treated with insulin pump therapy. METHODS: This prospective study was held at the participants' home. The participants completed the SCOFF questionnaire as well as a question related to insulin misuse. Information about lifestyle, medical history, insulin pump and Continuous Glucose Monitoring (CGM) data were collected. RESULTS: The analysis covered 198 participants with a median age of 51 [95% CI 38; 62] years. The prevalence of likely eating disorders was 21.7% (95% CI 16.3; 28.2) in the study population and 20.6% (95% CI 14.3; 28.6) and 24.2% (95% CI 14.6; 37.0) in males and females respectively. The prevalence of insulin misuse was 39.0% (95% CI 30.8; 47.7). There was no significant difference in prevalence between males and females for likely eating disorders and insulin misuse. The analysis of CGM data revealed no factors related to glycaemic control associated with likely eating disorders. CONCLUSION: The results of this study indicate that the prevalence of likely eating disorders is high even in a middle-aged population with a T1DM and satisfactory glucose control.

Clinical, Economic, and Patient-Reported Benefits of Connected Insulin Pen Systems: A Systematic Literature Review.

INTRODUCTION: The objective of this systematic literature review was to evaluate the available literature concerning the clinical, economic, and patient-reported benefits of insulin pen platforms, including connected insulin pens/caps/sleeves and insulin platforms, as well as mobile apps capable of receiving near real-time insulin dosing information. METHODS: Medline and Embase databases and the Cochrane Library were searched for published literature between January 2015 and May 2021, and manual searches for conference abstracts from 2018 to May 2021 were performed. These searches were supplemented by internet searches for relevant literature and clinical trials. Study selection involved the population, intervention, comparator, outcomes, time frame, and study design outline. Included studies investigated connected insulin systems or connected caps/sleeves enabling pens to be connected, or apps able to connect to these systems, in individuals of all ages with type 1 or type 2 diabetes mellitus. RESULTS: Searches identified a total of 26 publications (mostly observational studies and conference abstracts) for inclusion, representing ten unique, predominantly small studies. Evidence in this field is still in its early stages, and only two randomized controlled trials met our inclusion criteria. Available results showed that connected insulin pens and their systems potentially helped reduce suboptimal insulin use and may therefore improve glycemic control. Satisfaction of people with diabetes with the technologies used was high, and economic benefits were noted. Features of effective connected insulin pen devices include simplicity of use and data upload/sharing, useful "point-of-care" alerts, and simple and understandable data presentation to facilitate more effective consultations. CONCLUSIONS: Connected insulin pen systems could be increasingly considered as part of routine clinical care for insulin-treated persons with diabetes who must manage the complexity of their daily insulin routine. Future research focusing on the way data obtained from these devices can be most effectively used alongside other information is urgently needed.

Digital health tools, like text message reminders and mobile apps, are being used more often to help people with diabetes improve their health in a way that works for them. For people who take insulin to treat their diabetes, what has been missing is a way to track insulin doses alongside other diabetes information in an app. Connected insulin pens, also called smart pens, are able to do this. In this article we have looked at the evidence available on the benefits of connected insulin pens. We found that while information on connected insulin pens is limited at the moment, what there is shows that using a connected insulin pen can help people remember to take their insulin and give themselves the right dose and that those who have used a connected insulin pen or related technology are happy with it. Useful features of connected insulin pens include being easy to use, having an alert function, and being able to share the insulin information with the user's doctor. Connected insulin pens may also reduce diabetes-related costs. Connected insulin pens are likely to become more common for people with diabetes who take insulin, but there is a need for more research on how best to use them to improve the treatment of people with diabetes.

Automated Insulin Delivery Systems as a Treatment for Type 2 Diabetes Mellitus: A Review.

OBJECTIVE: Approximately 6.3% of the worldwide population has type 2 diabetes mellitus (T2DM), and the number of people requiring insulin is increasing. Automated insulin delivery (AID) systems integrate continuous subcutaneous insulin infusion and continuous glucose monitoring with a predictive control algorithm to provide more physiologic glycemic control. Personalized glycemic targets are recommended in T2DM owing to the heterogeneity of the disease. Based on the success of hybrid closed-loop systems in improving glycemic control and safety in type 1 diabetes mellitus, there has been further interest in the use of these systems in people with T2DM. METHODS: We performed a review of AID systems with a focus on the T2DM population. RESULTS: In 5 randomized controlled trials, AID systems improve time in range and reduce glycemic variability, without increasing insulin requirements or the risk of hypoglycemia. CONCLUSION: AID systems in T2DM are safe and effective in hospitalized and closely monitored settings. Home studies of longer duration are required to assess for long-term benefit and identify target populations of benefit.

An Intelligent Model-Based Effective Approach for Glycemic Control in Type-1 Diabetes.

Type-1 diabetes mellitus (T1DM) is a challenging disorder which essentially involves regulation of the glucose levels to avoid hyperglycemia as well as hypoglycemia. For this purpose, this research paper proposes and develops control algorithms using an intelligent predictive control model, which is based on a UVA/Padova metabolic simulator. The primary objective of the designed control laws is to provide an automatic blood glucose control in insulin-dependent patients so as to improve their life quality and to reduce the need of an extremely demanding self-management plan. Various linear and nonlinear control algorithms have been explored and implemented on the estimated model. Linear techniques include the Proportional Integral Derivative (PID) and Linear Quadratic Regulator (LQR), and nonlinear control strategy includes the Sliding Mode Control (SMC), which are implemented in this research work for continuous monitoring of glucose levels. Performance comparison based on simulation results demonstrated that SMC proved to be most efficient in terms of regulating glucose profile to a reference level of 70 mg/dL compared to the classical linear techniques. A brief comparison is presented between the linear techniques (PID and LQR), and nonlinear technique (SMC) for analysis purposes proving the efficacy of the design.

Insulin pump therapy is associated with higher rates of mild diabetic ketoacidosis compared to injection therapy: A 2-year Swedish national survey of children and adolescents with type 1 diabetes.

OBJECTIVES: Diabetic ketoacidosis (DKA) in type 1 diabetes (T1D) can occur during both insulin pump therapy (continuous subcutaneous insulin infusion, CSII) and insulin injection therapy (multiple daily injections, MDI). The primary aim of this study was to compare CSII and MDI regarding DKA frequency. A secondary aim was to compare metabolic derangement between CSII and MDI at hospital admission for DKA. RESEARCH DESIGN AND METHODS: Children 0-17.99 years with established T1D admitted for DKA in Sweden from February 1, 2015 to January 31, 2017 were invited to participate. Data regarding demographics, laboratory data, CSII or MDI, and access to ketone meters and CGM were provided through questionnaires and medical records. The Swedish National Diabetes Registry (SWEDIABKIDS) was used to compare the distribution of CSII and MDI in the national population with the population admitted for DKA, using the chi-square goodness-of-fit test. Distribution of CSII and MDI was then categorized in clinical severity grades for mild (pH 7.20-7.29), moderate (pH 7.10-7.29) and severe DKA (pH <7.10). RESULTS: The distribution of CSII at DKA admission was significantly larger than in the national pediatric population with T1D (74.7% vs. 59.7%, p = 0.002). CSII was overrepresented in mild DKA (85.2% vs. with CSII, p < 0.001), but not in moderate/severe DKA (57.9% with CSII, p = 0.82). Mean HbA1c at hospital admission was 73.9 mmol/mol with CSII and 102.7 mmol/mol with MDI. CONCLUSIONS: CSII was associated with higher risk of mild DKA than MDI. MDI was associated with markedly higher HbA1c levels than CSII at hospital admission for DKA.

Insulin Pump-Associated Adverse Events in a Brazilian Reference Center for the Treatment of Diabetes Mellitus: Proposal for a Taxonomy of Device Failures in Adults, Adolescents, and Children.

BACKGROUND: Since the introduction of continuous subcutaneous insulin infusion (CSII), the benefits have been numerous. However, adverse events (AEs) are experienced by up to 40% of users per year, exposing them to potentially fatal risks. The available evidence on the variables that trigger AEs associated with CSII remains limited, indicating the importance of studies on the subject. AIM: To propose a taxonomy based on the prevalent AEs experienced by patients from a reference diabetes mellitus (DM) center in Brazil using different CSII devices. METHODS: 118 patients participated in an online interview and answered the questions of the data collection instrument. Identifying categories and subcategories of analysis contributed to constructing the AEs taxonomy. RESULTS: The five analysis categories identified were: CSII User Interface (n = 45), CSII Alert System (n = 13), CSII Software and Connection (n = 11), CSII Durability (n = 30), and Electrical and Mechanical System of CSII (n = 60) A total of 159 AEs were identified, including conflicting alert messages and error/warning notification failures, errors resulting from engine malfunctions, data loss, patient interface deficiencies, button problems, and battery failure. CONCLUSIONS: The study describes in a taxonomic format the AEs directly associated with the use of modern CSIIs that may contribute with additional information to the Food and Drug Administration (FDA) Medical Device Report (MDR) adverse event codes. In addition to guiding educational actions in the treatment of DM and providing information for health professionals and medical device developers, prospective studies examining the frequency of such problems, including the potential psychosocial impact of this technologically advanced therapy, are needed.

Dual-hormone artificial pancreas for glucose control in type 1 diabetes: A meta-analysis.

AIM: To evaluate the efficacy and safety of a dual-hormone artificial pancreas (DH) in type 1 diabetes. MATERIAL AND METHODS: PubMed, Embase, the Cochrane Library and ClinicalTrials.gov were searched for studies published up to February 16, 2022. We included randomized controlled trials that compared DH with single-hormone artificial pancreas (SH), continuous subcutaneous insulin infusion (CSII) or sensor-augmented pumps (SAP), and predictive low glucose suspend systems (PLGS) in type 1 diabetes. The primary outcome was percent time in target (3.9-10 mmol/L [70-180 mg/dL]). Data were summarized as mean differences (MDs) or risk differences (RDs). RESULTS: A total of 17 randomized crossover trials (438 participants) were included. There were nine trials of DH versus SH, 13 trials of DH versus SAP/CSII, and two trials of DH versus PLGS. For time in target, DH showed no significant difference in time in target compared with SH (MD 2.69%, 95% confidence interval [CI] -0.38 to 5.76) but resulted in 16.05% (95% CI 12.06 to 20.05) and 6.89% (95% CI 2.63 to 11.14) more time in target range compared with SAP/CSII and PLGS, respectively. DH slightly reduced time in hypoglycaemia (MD -1.20%, 95% CI -1.85 to -0.56) but increased the risk of gastrointestinal symptoms (RD 0.18, 95% CI 0.08 to 0.27) compared with SH. CONCLUSIONS: The results of this study suggest that DH has a comparable effect on time in target compared with SH, but is associated with a longer time in target range compared with SAP/CSII and PLGS. The DH slightly reduced time in hypoglycaemia but may increase the risk of gastrointestinal symptoms compared with the SH. PROSPERO registration number: CRD42022314015.