We evaluated the safety and efficacy of fully closed-loop insulin therapy compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis. In an open-label, multinational, ...two-center, randomized crossover trial, 26 adults with type 2 diabetes requiring dialysis (17 men, 9 women, average age 68 ± 11 years (mean ± s.d.), diabetes duration of 20 ± 10 years) underwent two 20-day periods of unrestricted living, comparing the Cambridge fully closed-loop system using faster insulin aspart ('closed-loop') with standard insulin therapy and a masked continuous glucose monitor ('control') in random order. The primary endpoint was time in target glucose range (5.6-10.0 mmol l
). Thirteen participants received closed-loop first and thirteen received control therapy first. The proportion of time in target glucose range (5.6-10.0 mmol l
; primary endpoint) was 52.8 ± 12.5% with closed-loop versus 37.7 ± 20.5% with control; mean difference, 15.1 percentage points (95% CI 8.0-22.2; P < 0.001). Mean glucose was lower with closed-loop than control (10.1 ± 1.3 versus 11.6 ± 2.8 mmol l
; P = 0.003). Time in hypoglycemia (<3.9 mmol l
) was reduced with closed-loop versus control (median (IQR) 0.1 (0.0-0.4%) versus 0.2 (0.0-0.9%); P = 0.040). No severe hypoglycemia events occurred during the control period, whereas one severe hypoglycemic event occurred during the closed-loop period, but not during closed-loop operation. Fully closed-loop improved glucose control and reduced hypoglycemia compared with standard insulin therapy in adult outpatients with type 2 diabetes requiring dialysis. The trial registration number is NCT04025775.
Type 1 diabetes accounts for 5-10% of diabetes cases diagnosed worldwide.1 Hypoglycaemia is common and can limit efforts to tighten glucose control, lower quality of life,2 and increase mortality.3 ...Insulin analogues, structured education, insulin pump therapy, and continuous glucose monitoring have helped to decrease the burden of hypoglycaemia,4,5 but it remains considerable.
Abstract
The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. While maintaining near-normal glucose levels ...has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.
Graphical Abstract
Hybrid closed-loop systems are transforming the clinical management of T1DM. Large randomised controlled trials of hybrid closed-loop systems have demonstrated safety and efficacy, with significant ...improvements in glycaemic control compared to control therapy, and there are now several commercially approved hybrid closed-loop systems available in the UK. There is also a growing body of evidence demonstrating the quality of life benefits associated with hybrid closed-loop systems, both for users and also for parents/caregivers and other family members.
We review the clinical evidence supporting currently available hybrid closed-loop systems in the UK and also new systems on the horizon. We discuss the emerging evidence for associated psychosocial benefits of hybrid closed-loop therapy. We also address future challenges around healthcare professional readiness to deliver closed-loop technology and ensuring equitable access across the UK.
In this crossover study involving pregnant women with type 1 diabetes, overnight closed-loop insulin delivery resulted in better glucose control than sensor-augmented pump therapy.
Complications of ...type 1 diabetes mellitus during pregnancy include increased rates of congenital anomaly, stillbirth, neonatal death, preterm delivery, and macrosomia.
1
Congenital anomalies are associated with poor glycemic control around the time of conception, whereas the other complications are associated with maternal hyperglycemia that persists during pregnancy.
2
–
5
Pregnant women with type 1 diabetes face particular challenges in trying to maintain tight glycemic control. Insulin requirements typically increase by a factor of 2 to 3 during the second and third trimesters, with substantial day-to-day variability, making the need for dose adjustments and their required magnitude unpredictable.
6
,
7
Even with regular . . .
To evaluate feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions without remote monitoring or ...supervision.
In an open-label, randomized, free-living, crossover study design, 12 adolescents receiving insulin pump therapy (mean ±SD age 15.4 ± 2.6 years; HbA1c 8.3 ± 0.9%; duration of diabetes 8.2 ± 3.4 years) underwent two 7-day periods of sensor-augmented insulin pump therapy or hybrid closed-loop insulin delivery without supervision or remote monitoring. During the closed-loop insulin delivery, a model predictive algorithm automatically directed insulin delivery between meals and overnight; prandial boluses were administered by participants using a bolus calculator.
The proportion of time when the sensor glucose level was in the target range (3.9-10 mmol/L) was increased during closed-loop insulin delivery compared with sensor-augmented pump therapy (72 vs. 53%, P < 0.001; primary end point), the mean glucose concentration was lowered (8.7 vs. 10.1 mmol/L, P = 0.028), and the time spent above the target level was reduced (P = 0.005) without changing the total daily insulin amount (P = 0.55). The time spent in the hypoglycemic range was low and comparable between interventions.
Unsupervised day-and-night hybrid closed-loop insulin delivery at home is feasible and safe in young people with type 1 diabetes. Compared with sensor-augmented insulin pump therapy, closed-loop insulin delivery may improve glucose control without increasing the risk of hypoglycemia in adolescents with suboptimally controlled type 1 diabetes.
Background:
We analyzed real-world evidence to assess the performance of the mylife CamAPS FX hybrid closed-loop system.
Methods:
Users from 15 countries across different age groups who used the ...system between May 9, 2022, and December 3, 2022, and who had ≥30 days of continuous glucose monitor data, and ≥30% of closed-loop usage were included in the current analysis (N = 1805).
Results:
Time in range (3.9-10 mmol/L) was 72.6 ± 11.5% (mean ± SD) for all users and increased by age from 66.9 ± 11.7% for users ≤6 years old to 81.8 ± 8.7% for users ≥65 years. Time spent in hypoglycemia (<3.9 mmol/L) was 2.3% 1.3, 3.6 (median interquartile range). Mean glucose and glucose management indicator were 8.4 ± 1.1 mmol/L and 6.9%, respectively. Time using closed-loop was high at 94.7% 90.0, 96.9.
Conclusions:
Glycemic outcomes from the present real-world evidence are comparable to results obtained from previous randomized controlled studies and confirm the efficacy of this hybrid closed-loop system in real-world settings.
Introduction: Major abdominal surgery predisposes to hyperglycemia due to metabolic stress, inflammation, perioperative nutrition support and medication. The aim of the study was to assess the ...efficacy of fully closed-loop (FCL) versus usual care (UC) insulin delivery for glycemic management in major abdominal surgery patients. Methods: In this randomized controlled trial (NCT05392452) we compared perioperative use of the CamAPS HX FCL system (Dexcom G6, YspoPump, SC faster insulin aspart) with UC insulin treatment from admission until hospital discharge (max 20 days) at two tertiary hospitals in Switzerland. The primary endpoint was % time in sensor glucose target range (5.6-10.0mmol/L). Results: Thirty-seven patients (FCL n=18, UC n=19, 27% female, mean±SD age 66±12 years, BMI 27.8±5.7 kg/m2, HbA1C 6.9±1.0 %) were analyzed. Mean±SD % time in target glucose range (5.6-10.0mmol/L) was 80.1±10.0 % with FCL vs 53.7±19.7 % with UC (p<0.001). Time in hypoglycemia (<3.9mM and <3.0mM) did not differ between groups. Total daily insulin dose was significantly higher in the FCL vs UC group (p<0.001). Conclusions: Perioperative use of FCL insulin delivery in major abdominal surgery patients with complex medical needs results in significantly better glucose control compared to standard insulin therapy without increasing the risk of hypoglycemia. Disclosure G. Krutkyte: None. A. Goerg: None. C.A. Grob: None. G. Beldi: None. A. Wenning: None. R. Hovorka: Other Relationship; CamDiab. Research Support; Abbott, Dexcom, Inc., Ypsomed AG. Speaker's Bureau; Ypsomed AG, Abbott, Novo Nordisk, Novartis Pharmaceuticals Corporation. M.E. Wilinska: Consultant; CamDiab. D. Herzig: Speaker's Bureau; Ypsomed AG. A. Vogt: None. T. Girard: None. L. Bally: None. Funding Helmut Horten FoundationScherbarth Foundation and intramural grants of the Department of Anaesthesiology and Pain Medicine, University Hospital BernSwiss Foundation for Anaesthesiology and Intensive CareClinic for Anaesthesiology, University Hospital BaselFreiwillige Akademische Gesellschaft Basel
Despite advances in technology, optimal glucose control remains elusive and neonatal complications remain ubiquitous in type 1 diabetes (T1D) pregnancy. Our aim was to examine the safety, efficacy, ...and longer-term feasibility of day-and-night closed-loop insulin delivery.
We recruited 16 pregnant women (mean SD: age 32.8 5.0 years, T1D duration 19.4 10.2 years, HbA
8.0% 1.1, and BMI 26.6 4.4 kg/m
) to an open-label, randomized, crossover trial. Participants completed 28 days of closed-loop and sensor-augmented pump (SAP) insulin delivery separated by a washout period. Afterward, participants could continue to use the closed-loop system up to 6 weeks postpartum. The primary end point was the proportion of time with glucose levels within the target range (63-140 mg/dL).
The proportion of time with glucose levels within target was comparable during closed-loop and SAP insulin delivery (62.3 vs. 60.1% 95% CI -4.1 to 8.3;
= 0.47). Mean glucose and time spent hyperglycemic >140 mg/dL also did not differ (131.4 vs. 131.4 mg/dL
= 0.85 and 36.6 vs. 36.1%
= 0.86, respectively). During closed-loop, fewer hypoglycemic episodes occurred (median 8 range 1-17 vs. 12.5 1-53 over 28 days;
= 0.04) and less time at <63 mg/dL (1.6 vs. 2.7%;
= 0.02). Hypoglycemia <50 mg/dL (0.24 vs. 0.47%;
= 0.03) and low blood glucose index (1.0 vs. 1.4;
= 0.01) were lower. Less nocturnal hypoglycemia (2300-0700 h) during closed-loop therapy (1.1 vs. 2.7%;
= 0.008) and a trend toward higher overnight time in target (67.7 vs. 60.6%;
= 0.06) were found.
Closed-loop insulin delivery was associated with comparable glucose control and significantly less hypoglycemia than SAP therapy. Larger, longer-duration multicenter trials are now indicated to determine clinical efficacy of closed-loop insulin delivery in T1D pregnancy and the impact on neonatal outcomes.
The achievement of glycaemic control remains challenging for patients with type 1 diabetes. We assessed the effectiveness of day-and-night hybrid closed-loop insulin delivery compared with ...sensor-augmented pump therapy in people with suboptimally controlled type 1 diabetes aged 6 years and older.
In this open-label, multicentre, multinational, single-period, parallel randomised controlled trial, participants were recruited from diabetes outpatient clinics at four hospitals in the UK and two centres in the USA. We randomly assigned participants with type 1 diabetes aged 6 years and older treated with insulin pump and with suboptimal glycaemic control (glycated haemoglobin HbA1c 7·5–10·0%) to receive either hybrid closed-loop therapy or sensor-augmented pump therapy over 12 weeks of free living. Training on study insulin pump and continuous glucose monitoring took place over a 4-week run-in period. Eligible subjects were randomly assigned using central randomisation software. Allocation to the two study groups was unblinded, and randomisation was stratified within centre by low (<8·5%) or high (≥8·5%) HbA1c. The primary endpoint was the proportion of time that glucose concentration was within the target range of 3·9–10·0 mmol/L at 12 weeks post randomisation. Analyses of primary outcome and safety measures were done in all randomised patients. The trial is registered with ClinicalTrials.gov, number NCT02523131, and is closed to accrual.
From May 12, 2016, to Nov 17, 2017, 114 individuals were screened, and 86 eligible patients were randomly assigned to receive hybrid closed-loop therapy (n=46) or sensor-augmented pump therapy (n=40; control group). The proportion of time that glucose concentration was within the target range was significantly higher in the closed-loop group (65%, SD 8) compared with the control group (54%, SD 9; mean difference in change 10·8 percentage points, 95% CI 8·2 to 13·5; p<0·0001). In the closed-loop group, HbA1c was reduced from a screening value of 8·3% (SD 0·6) to 8·0% (SD 0·6) after the 4-week run-in, and to 7·4% (SD 0·6) after the 12-week intervention period. In the control group, the HbA1c values were 8·2% (SD 0·5) at screening, 7·8% (SD 0·6) after run-in, and 7·7% (SD 0·5) after intervention; reductions in HbA1c percentages were significantly greater in the closed-loop group compared with the control group (mean difference in change 0·36%, 95% CI 0·19 to 0·53; p<0·0001). The time spent with glucose concentrations below 3·9 mmol/L (mean difference in change −0·83 percentage points, −1·40 to −0·16; p=0·0013) and above 10·0 mmol/L (mean difference in change −10·3 percentage points, −13·2 to −7·5; p<0·0001) was shorter in the closed-loop group than the control group. The coefficient of variation of sensor-measured glucose was not different between interventions (mean difference in change −0·4%, 95% CI −1·4% to 0·7%; p=0·50). Similarly, total daily insulin dose was not different (mean difference in change 0·031 U/kg per day, 95% CI −0·005 to 0·067; p=0·09) and bodyweight did not differ (mean difference in change 0·68 kg, 95% CI −0·34 to 1·69; p=0·19). No severe hypoglycaemia occurred. One diabetic ketoacidosis occurred in the closed-loop group due to infusion set failure. Two participants in each study group had significant hyperglycaemia, and there were 13 other adverse events in the closed-loop group and three in the control group.
Hybrid closed-loop insulin delivery improves glucose control while reducing the risk of hypoglycaemia across a wide age range in patients with suboptimally controlled type 1 diabetes.
JDRF, NIHR, and Wellcome Trust.
PDF
