Patient-reported outcomes for older adults on CamAPS FX closed loop system.

AIMS: Use of the CamAPS FX hybrid closed loop (CL) system is associated with improved time in range and glycated haemoglobin A1c across the age span, but little is known about its effects on patient-reported outcomes (PROs). METHODS: This open-label, randomized, multi-site study compared CamAPS FX to sensor-augmented pump (SAP) in a sample of older adults (≥60 years) with type 1 diabetes (T1D). Thirty-five older adults completed PROs surveys at the start of the study and after each period of 16 weeks using either CL or SAP. At the end of the study, 19 participated in interviews about their experiences with CL. RESULTS: Results examining the 16 weeks of CL use showed that the overall Diabetes Distress Scale score and two subscales (powerlessness and physician distress) improved significantly along with trust on the Glucose Monitoring Satisfaction Survey. User experience interview responses were consistent in noting benefits of 'improved glycaemic control' and 'worrying less about diabetes'. CONCLUSION: In this sample of older adults with T1D who have previously shown glycaemic benefit, there are indicators of improved PROs and subjective user experience benefits.

Closed-loop insulin delivery in end-of-life care: a case report.

BACKGROUND: Glucose management for people with diabetes approaching the end of life can be very challenging. The aim is to balance a minimally invasive approach with avoidance of symptomatic hypo- and hyperglycaemia. CASE REPORT: We present a case of a hospitalized individual whose glucose was managed with closed-loop insulin delivery within a randomized controlled trial setting during a period of terminal illness. During the time in which closed-loop insulin delivery was used, glucose control was safe, with no glucose-related harm. The mean ± sd sensor glucose for this individual was 11.3 ± 4.3 mmol/l, percentage of time spent in target glucose range between 6 and 15 mmol/l was 70.5%, time spent in hypoglycaemia was 2.0% and time spent in significant hyperglycaemia >20 mmol/l was 2.6%. CONCLUSION: Closed-loop systems can accommodate personalized glucose targets and highly variable insulin requirements. Factory-calibrated continuous glucose sensors and insulin pump therapy are less intrusive than finger-stick glucose measurements and insulin injections, respectively. Closed-loop systems may provide a safer and less burdensome approach to glucose management towards the end of life.

Home Use of an Artificial Beta Cell in Type 1 Diabetes.

BACKGROUND: The feasibility, safety, and efficacy of prolonged use of an artificial beta cell (closed-loop insulin-delivery system) in the home setting have not been established. METHODS: In two multicenter, crossover, randomized, controlled studies conducted under free-living home conditions, we compared closed-loop insulin delivery with sensor-augmented pump therapy in 58 patients with type 1 diabetes. The closed-loop system was used day and night by 33 adults and overnight by 25 children and adolescents. Participants used the closed-loop system for a 12-week period and sensor-augmented pump therapy (control) for a similar period. The primary end point was the proportion of time that the glucose level was between 70 mg and 180 mg per deciliter for adults and between 70 mg and 145 mg per deciliter for children and adolescents. RESULTS: Among adults, the proportion of time that the glucose level was in the target range was 11.0 percentage points (95% confidence interval [CI], 8.1 to 13.8) greater with the use of the closed-loop system day and night than with control therapy (P<0.001). The mean glucose level was lower during the closed-loop phase than during the control phase (difference, -11 mg per deciliter; 95% CI, -17 to -6; P<0.001), as were the area under the curve for the period when the glucose level was less than 63 mg per deciliter (39% lower; 95% CI, 24 to 51; P<0.001) and the mean glycated hemoglobin level (difference, -0.3%; 95% CI, -0.5 to -0.1; P=0.002). Among children and adolescents, the proportion of time with the nighttime glucose level in the target range was higher during the closed-loop phase than during the control phase (by 24.7 percentage points; 95% CI, 20.6 to 28.7; P<0.001), and the mean nighttime glucose level was lower (difference, -29 mg per deciliter; 95% CI, -39 to -20; P<0.001). The area under the curve for the period in which the day-and-night glucose levels were less than 63 mg per deciliter was lower by 42% (95% CI, 4 to 65; P=0.03). Three severe hypoglycemic episodes occurred during the closed-loop phase when the closed-loop system was not in use. CONCLUSIONS: Among patients with type 1 diabetes, 12-week use of a closed-loop system, as compared with sensor-augmented pump therapy, improved glucose control, reduced hypoglycemia, and, in adults, resulted in a lower glycated hemoglobin level. (Funded by the JDRF and others; AP@home04 and APCam08 ClinicalTrials.gov numbers, NCT01961622 and NCT01778348.).

Bolusing frequency and amount impacts glucose control during hybrid closed-loop.

AIM: To compare bolus insulin delivery patterns during closed-loop home studies in adults with suboptimally [HbA1c 58-86 mmol/mol (7.5%-10%)] and well-controlled [58 mmol/mol (< 7.5%)] Type 1 diabetes. METHODS: Retrospective analysis of daytime and night-time insulin delivery during home use of closed-loop over 4 weeks. Daytime and night-time controller effort, defined as amount of insulin delivered by closed-loop relative to usual basal insulin delivery, and daytime bolus effort, defined as total bolus insulin delivery relative to total daytime insulin delivery were compared between both cohorts. Correlation analysis was performed between individual bolus behaviour (bolus effort and frequency) and daytime controller efforts, and proportion of time spent within and below sensor glucose target range. RESULTS: Individuals with suboptimally controlled Type 1 diabetes had significantly lower bolus effort (P = 0.038) and daily bolus frequency (P < 0.001) compared with those with well-controlled diabetes. Controller effort during both daytime (P = 0.007) and night-time (P = 0.005) were significantly higher for those with suboptimally controlled Type 1 diabetes. Time when glucose was within the target range (3.9-10.0 mmol/L) during daytime correlated positively with bolus effort (r = 0.37, P = 0.016) and bolus frequency (r = 0.33, P = 0.037). Time when glucose was below the target range during daytime was comparable in both groups (P = 0.36), and did not correlate significantly with bolus effort (r = 0.28, P = 0.066) or bolus frequency (r = -0.21, P = 0.19). CONCLUSION: More frequent bolusing and higher proportion of insulin delivered as bolus during hybrid closed-loop use correlated positively with time glucose was in target range. This emphasises the need for user input and educational support to benefit from this novel therapeutic modality.

Effectiveness of a multidisciplinary team approach to the prevention of readmission for acute glycaemic events.

AIMS: To describe the effect of a combined diabetes specialist/mental health team approach to prevent readmissions for acute glycaemic events among patients with diabetes. METHODS: Consecutive patients with diabetes, readmitted to a single hospital for an acute glycaemic condition, were offered one or more diabetes (including assessment, education, medication, technology use and intensive support) and mental health (including assessment, training and therapies) interventions. The pilot service took place over 11 months, with the preceding 24 months and subsequent 8 months serving as control periods. RESULTS: Of the 58 patients admitted, 50 had Type 1 diabetes and were from within the hospital catchment area, and were discharged home. Of these, 32 (64%) had a pre-existing mental health issue and 14 (28%) had a complex social situation. In all, 96% of patients were met as an inpatient by a team member, and 94% accepted at least one intervention. The mean ±sd number of admissions per patient/month dropped from 0.12 ± 0.10 to 0.05 ± 0.10 (P < 0.001) during the intervention, increasing, once the intervention ended, to 0.16 ± 0.36 (P = 0.002). The mean ± sd length of stay similarly decreased and increased (0.6 ± 0.9 to 0.2 ± 0.7 days; P < 0.001 to 0.006) to 0.6 ± 1.4 days (P = 0.003) per patient/month) across the three periods, as did the mean ±sd tariff paid per patient/month (£258.0 ± 374.0 vs £92.1 ± 245.0 vs £287.3 ± 563.8; P < 0.001 and P = 0.018, respectively). The mean ± sd HbA1c level dropped from 99 ± 22 to 92 ± 24 mmol/mol (11.2 ± 4.2% vs 10.6 ± 4.3%; P = 0.014) but did not increase after the intervention [89 ± 26 mmol/mol (10.4 ± 4.5%)]. CONCLUSIONS: The cost and long-term risks of hospitalization among patients with Type 1 diabetes and recurrent admissions can be reduced by a combined specialist diabetes/mental health team approach.

Robust, routine haematology reference ranges for healthy adults.

Accurate, reliable laboratory reference ranges are essential for effective clinical evaluation and monitoring. We present robust reference ranges established for haematology, coagulation and haematinic parameters using the Sysmex XE 2100, CA 1500 and Beckman-Coulter Access analysers. Blood samples were taken from 250 healthy laboratory personnel and routine haematology, coagulation and haematinic parameter analysis performed. Our data represent findings from an extensive study to establish reference ranges in healthy adults.