Perspectives of culturally and linguistically diverse families in the management of children with type 1 diabetes in Western Australia.

OBJECTIVES: Children with Type 1 diabetes (T1D) from different ethnic backgrounds are growing in proportion in clinical practice and tend to have a higher risk of poor health outcomes. The study aimed to investigate the perspectives of culturally and linguistically diverse families in the management of children with T1D in Western Australia. DESIGN: A generic qualitative approach was used. Families of children and adolescents with T1D with first-generation African, Asian or Middle Eastern background were invited to participate in a semi-structured interview. The interviews were audio-recorded, transcribed and analysed thematically. Demographic, clinical and socio-economic data were collected from all participants. RESULTS: Fifteen families (27% African, 33% Middle Eastern, 40% Asian) participated in the study. The mean (SD) age of the child with T1D was 10.2 (5.1) years, had diabetes for 2.9 (1.6) years and an average HbA1c of 67 (15) mmol/mol. Four main themes were identified through qualitative analysis. 'Dietary challenges': lack of adequate food resources posed a barrier to determine carbohydrate amount in traditional meals; 'Linguistic challenges': inadequate reading and language skills affected comprehension of written information and the desire for pictorial resources was reported; 'Limited Support': absence of extended family made management of T1D difficult; and 'Knowledge': a key facilitator, which was acquired through clinic education, enabled families to develop skills to effectively manage T1D. CONCLUSION: The study highlights the need to consider cultural diversity, psychosocial needs, English proficiency and health literacy when assessing and planning diabetes education. These findings will be useful to formulate a more culturally sensitive approach to diabetes education to improve care and outcomes for young people with T1D from culturally and linguistically diverse families.

Psychological flexibility is associated with less diabetes distress and lower glycated haemoglobin in adults with type 1 diabetes.

BACKGROUND: Diabetes distress, self-efficacy and health literacy are associated with diabetes self-management and health outcomes. Measures of coping styles and their impact on diabetes self-management and diabetes-related distress might add value in identifying those at risk of poorer health outcomes. Current evidence of associations between psychological flexibility/inflexibility and diabetes-related health outcomes is limited. AIMS: To measure associations of psychological flexibility, self-efficacy and health literacy with diabetes distress and glycated haemoglobin (HbA1c) in adults with type 1 diabetes. METHODS: We surveyed 105 adults with type 1 diabetes attending a tertiary diabetes outpatient clinic (mean age 27 ± 7.1 years; 53% men; duration of diabetes 12.6 ± 8.5 years; HbA1c 72 ± 22 mmol/mol, 8.7 ± 2.0%; 34% using insulin pumps). We assessed psychological flexibility, self-efficacy, health literacy and diabetes distress. Regression models explored the relative contributions of different factors to diabetes distress and HbA1c. RESULTS: The majority of health literacy scores were in the low-risk range. Those with greater psychological flexibility had higher self-efficacy (r = 0.34; P < 0.01) and reported less diabetes distress (r = -0.54; P < 0.001). In multiple regression analyses, psychological flexibility and self-efficacy accounted for 36% of the variance in distress score (P < 0.001). Shorter duration of diabetes (P < 0.001) and greater psychological flexibility (P < 0.01) correlated with lower HbA1c. A 10-point (one standard deviation) higher psychological flexibility score corresponded to a 0.5% lower HbA1c. CONCLUSIONS: Greater psychological flexibility was associated with less diabetes distress and lower HbA1c. The psychological flexibility construct might inform alternative interventional approaches aiming to improve well-being and glycaemic control.

Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: a randomized clinical trial.

IMPORTANCE: Hypoglycemia is a critical obstacle to the care of patients with type 1 diabetes. Sensor-augmented insulin pump with automated low-glucose insulin suspension has the potential to reduce the incidence of major hypoglycemic events. OBJECTIVE: To determine the incidence of severe and moderate hypoglycemia with sensor-augmented pump with low-glucose suspension compared with standard insulin pump therapy. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial involving 95 patients with type 1 diabetes, recruited from December 2009 to January 2012 in Australia. INTERVENTIONS: Patients were randomized to insulin pump only or automated insulin suspension for 6 months. MAIN OUTCOMES AND MEASURES: The primary outcome was the combined incidence of severe (hypoglycemic seizure or coma) and moderate hypoglycemia (an event requiring assistance for treatment). In a subgroup, counterregulatory hormone responses to hypoglycemia were assessed using the hypoglycemic clamp technique. RESULTS: Of the 95 patients randomized, 49 were assigned to the standard-pump (pump-only) therapy and 46 to the low-glucose suspension group. The mean (SD) age was 18.6 (11.8) years; duration of diabetes, 11.0 (8.9) years; and duration of pump therapy, 4.1 (3.4) years. The baseline rate of severe and moderate hypoglycemic events in the pump-only group was 20.7 vs 129.6 events per 100 patient months in the low-glucose suspension group. After 6 months of treatment, the event rates decreased from 28 to 16 in the pump-only group vs 175 to 35 in the low-glucose suspension group. The adjusted incidence rate per 100 patient-months was 34.2 (95% CI, 22.0-53.3) for the pump-only group vs 9.5 (95% CI, 5.2-17.4) for the low-glucose suspension group. The incidence rate ratio was 3.6 (95% CI, 1.7-7.5; P <.001). There was no change in glycated hemoglobin in either group: mean, 7.4 (95% CI, 7.2-7.6) to 7.4 (95% CI, 7.2-7.7) in the pump-only group vs mean, 7.6 (95%, CI, 7.4-7.9) to 7.5 (95% CI, 7.3-7.7) in the low-glucose suspension group. Counterregulatory hormone responses to hypoglycemia were not changed. There were no episodes of diabetic ketoacidosis or hyperglycemia with ketosis. CONCLUSIONS AND RELEVANCE: Sensor-augmented pump therapy with automated insulin suspension reduced the combined rate of severe and moderate hypoglycemia in patients with type 1 diabetes. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12610000024044.

Effect of frequency of sensor use on glycaemic control in individuals on sensor-augmented pump therapy with and without Predictive Low Glucose Management System.

Improved frequency of sensor use improves glycaemic control. Furthermore, there is no deterioration of glycaemic control with increased sensor use in individuals on Predictive Low Glucose Management (PLGM) system. Younger children are more likely to have better sensor uptake than older children.

Characteristics of Automated Insulin Suspension and Glucose Responses with the Predictive Low-Glucose Management System.

BACKGROUND: The Predictive Low-Glucose Management (PLGM) system suspends basal insulin when hypoglycemia is predicted and reduces hypoglycemia. The aim of this analysis was to explore the characteristics of automated insulin suspension and sensor glucose (SG) responses following PLGM-initiated pump suspension. RESEARCH DESIGN AND METHODS: Children and adolescents with type 1 diabetes used the Medtronic MiniMed™ 640G pump as part of a randomized controlled trial. Data collected on a subgroup of participants on PLGM (suspend before low enabled) from CareLink® Therapy Management Software were analyzed to explore the time and duration of PLGM-initiated pump suspension. Day and nighttime were defined as 06:00 am to 10:00 pm and 10:00 pm to 6:00 am, respectively. RESULTS: There were 20,183 suspend before low events in 8523 days (2.37 events/day). The mean suspend duration was 55.0 ± 32.7 min (day 50.0 ± 30.1, night 71.7 ± 35.1; P < 0.001). Although a 2-h pump suspension was more frequent at night (day 5%, night 18%), a patient-initiated resumption occurred more during day (day 34%, night 12%). SG values did not reach <3.5 and <3 mmol/L in 79% and 91% of the events, respectively. The 2-h SG following pump resumption was higher following autoresumption during the day (day vs. night 9.3 mmol/L vs. 8.4 mmol/L; P < 0.001). CONCLUSIONS: Longer suspends and fewer glycemic excursions occur at night compared with day. The higher glycemic daytime excursions could be due to carbohydrate consumption to increase glucose levels and highlights the need for health care professionals to educate patients about carbohydrate intake around pump suspension.

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.

Reduction in Hypoglycemia With the Predictive Low-Glucose Management System: A Long-term Randomized Controlled Trial in Adolescents With Type 1 Diabetes.

OBJECTIVE: Short-term studies with automated systems that suspend basal insulin when hypoglycemia is predicted have shown a reduction in hypoglycemia; however, efficacy and safety have not been established in long-term trials. RESEARCH DESIGN AND METHODS: We conducted a 6-month, multicenter, randomized controlled trial in children and adolescents with type 1 diabetes using the Medtronic MiniMed 640G pump with Suspend before low (predictive low-glucose management [PLGM]) compared with sensor-augmented pump therapy (SAPT) alone. The primary outcome was percentage time in hypoglycemia with sensor glucose (SG) <3.5 mmol/L (63 mg/dL). RESULTS: In an intent-to-treat analysis of 154 subjects, 74 subjects were randomized to SAPT and 80 subjects to PLGM. At baseline, the time with SG <3.5 mmol/L was 3.0% and 2.8% in the SAPT and PLGM groups, respectively. During the study, PLGM was associated with a reduction in hypoglycemia compared with SAPT (% time SG <3.5 mmol/L: SAPT vs. PLGM, 2.6 vs. 1.5, P < 0.0001). A similar effect was also noted in time with SG <3 mmol/L (P < 0.0001). This reduction was seen both during day and night (P < 0.0001). Hypoglycemic events (SG <3.5 mmol/L for >20 min) also declined with PLGM (SAPT vs. PLGM: events/patient-year 227 vs. 139, P < 0.001). There was no difference in glycated hemoglobin (HbA1c) at 6 months (SAPT 7.6 ± 1.0% vs. PLGM 7.8 ± 0.8%, P = 0.35). No change in quality of life measures was reported by participants/parents in either group. There were no PLGM-related serious adverse events. CONCLUSIONS: In children and adolescents with type 1 diabetes, PLGM reduced hypoglycemia without deterioration in glycemic control.

Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol.

INTRODUCTION: Manual determination of insulin dosing largely fails to optimise glucose control in type 1 diabetes. Automated insulin delivery via closed-loop systems has improved glucose control in short-term studies. The objective of the present study is to determine the effectiveness of 6 months' closed-loop compared with manually determined insulin dosing on time-in-target glucose range in adults with type 1 diabetes. METHODS AND ANALYSIS: This open-label, seven-centre, randomised controlled parallel group clinical trial will compare home-based hybrid closed-loop versus standard diabetes therapy in Australia. Adults aged ≥25 years with type 1 diabetes using intensive insulin therapy (via multiple daily injections or insulin pump, total enrolment target n=120) will undertake a run-in period including diabetes and carbohydrate-counting education, clinical optimisation and baseline data collection. Participants will then be randomised 1:1 either to 26 weeks of MiniMed 670G hybrid closed-loop system therapy (Medtronic, Northridge, CA, USA) or continuation of their current diabetes therapy. The hybrid closed-loop system delivers insulin automatically to address basal requirements and correct to target glucose level, while bolus doses for meals require user initiation and carbohydrate estimation. Analysis will be intention to treat, with the primary outcome time in continuous glucose monitoring (CGM) target range (3.9-10.0 mmol/L) during the final 3 weeks of intervention. Secondary outcomes include: other CGM parameters, HbA1c, severe hypoglycaemia, psychosocial well-being, sleep, cognition, electrocardiography, costs, quality of life, biomarkers of vascular health and hybrid closed-loop system performance. Semistructured interviews will assess the expectations and experiences of a subgroup of hybrid closed-loop users. ETHICS AND DISSEMINATION: The study has Human Research Ethics Committee approval. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Results will be disseminated at scientific conferences and via peer-reviewed publications. TRIAL REGISTRATION NUMBER: ACTRN12617000520336; Pre-results.

Analysis of glucose responses to automated insulin suspension with sensor-augmented pump therapy.

OBJECTIVE: The advent of sensor-augmented pump therapy with a low-glucose suspend (LGS) function (Medtronic Paradigm Veo System), allowing insulin to be automatically suspended for up to 2 h when sensor glucose falls below a preset threshold, has the potential to reduce the duration of hypoglycemia. In this article, we analyzed blood glucose profiles following a full 2-h insulin suspension activated by the LGS function, as well as examined different patterns of use among patients. RESEARCH DESIGN AND METHODS: Data from a cohort of participants using the Veo System for up to 6 months were analyzed to determine the time and duration of insulin suspension activated by the LGS function. We further evaluated overnight suspend events with no patient response occurring prior to 3:00 a.m., which allowed us to determine the pattern of sensor glucose values with no patient intervention during and after the period of insulin suspension. RESULTS: There were 3,128 LGS events during the 2,493 days evaluated. The median duration was 11.2 min, and 36% of events occurred overnight. There were 126 full 2-h suspend events that occurred overnight with no patient response, occurring before 3:00 a.m. For these events, the mean sensor glucose at the end of the 2-h suspend period was 99 ± 6 mg/dL ([means ± SE] 5.5 ± 0.3 mmol/L). The mean sensor glucose 2 h after insulin delivery resumed was 155 ± 10 mg/dL (8.6 ± 0.6 mmol/L). There were no episodes of severe hypoglycemia or diabetic ketoacidosis. CONCLUSIONS: Analyses of sensor glucose patterns following insulin suspension activated by LGS suggest that this technology is safe and unlikely to be associated with adverse outcomes.