Aim
The Diabeloop Generation 1 (DBLG1) system is an interoperable hybrid closed‐loop solution that was commercialized in Germany in March 2021. We report the longitudinal glycaemic outcomes among the ...first 3706 users in a real‐world setting.
Methods
We performed a retrospective data collection of all consenting adult patients with type 1 diabetes who were equipped in Germany with the DBLG1 system before 30 April 2022, and with a minimum 14 days of closed‐loop usage.
Results
In total, 3706 users (41% women, age 45.1 ± 14.5 years) met the inclusion criteria, reaching a mean follow‐up of 131.0 ± 85.1 days, an overall 485 600 days of continuous glucose monitoring data, and a median time spent in closed‐loop of 95.0% (IQR 89.1‐97.4). The median percentage time in range (70‐180 mg/dl) was 72.1% (IQR 65.0‐78.9); the time below 70 mg/dl was 0.9% (0.5‐1.7), the time below 54 mg/dl was 0.1% (0.1‐0.3), and the median Glucose Management Index was 7.0% (6.8‐7.3). Exploratory analysis of a subset of 2460 patients in whom baseline glycated haemoglobin (HbA1c) was available 7.4% (IQR 6.9‐8.0) showed that the achieved mean time in range was influenced by baseline HbA1c, ranging from 65.8 ± 9.9% (A1c ≥8.5%) to 81.3 ± 6.8% (A1c <6.5%).
Conclusion
This large real‐world analysis confirms the relevance of the DBLG1 automated insulin delivery solution for the achievement of standards of care in adult patients with type 1 diabetes.
Aim
To compare the efficacy of the closed‐loop Diabeloop for highly unstable diabetes (DBLHU) system with the open‐loop predictive low glucose suspend (PLGS) system in patients with highly unstable ...type 1 diabetes (T1D) who experience acute metabolic events.
Methods
DBLHU‐WP10 was an interventional, controlled, randomized, open‐label study that comprised two cycles of N‐of‐1 trials (2‐of‐1 trials). Each trial consisted of two crossover 4‐week periods of treatment with either DBLHU or PLGS in randomized order. The primary outcome was the percentage of time spent in the 70‐180 mg/dL glucose range (time in range TIR).
Results
Five out of seven randomized patients completed the aggregated 2‐of‐1 trials. TIR was significantly higher with DBLHU (73.3% ± 1.7%) compared with PLGS (43.5% ± 1.7%; P < .0001). The percentage of time below 70 mg/dL was significantly lower with DBLHU (0.9% ± 0.4%) versus PLGS (3.7% ± 0.4%; P < .0001). DBLHU was also significantly superior to PLGS in reducing hyperglycaemic excursions and improving almost all other secondary outcomes, including glucose variability and satisfaction score. No adverse event could be related to the experimental treatment.
Conclusions
DBLHU was superior to PLGS in improving the metabolic control of patients with highly unstable T1D who require an islet or pancreas transplant but who either have a contraindication or refuse to consent.
To describe the 10‐year outcomes of islet transplantation within the Swiss‐French GRAGIL Network, in patients with type 1 diabetes experiencing high glucose variability associated with severe ...hypoglycemia and/or with functional kidney graft. We conducted a retrospective analysis of all subjects transplanted in the GRAGIL‐1c and GARGIL‐2 islet transplantation trials and analyzed components of metabolic control, graft function and safety outcomes over the 10‐year period of follow‐up. Forty‐four patients were included between September 2003 and April 2010. Thirty‐one patients completed a 10‐year follow‐up. Ten years after islet transplantation, median HbA1c was 7.2% (6.2–8.0) (55 mmol/mol 44–64) versus 8.0% (7.1–9.1) (64 mmol/mol 54–76) before transplantation (p < .001). Seventeen of 23 (73.9%) recipients were free of severe hypoglycemia, 1/21 patients (4.8%) was insulin‐independent and median C‐peptide was 0.6 ng/ml (0.2–1.2). Insulin requirements (UI/kg/day) were 0.3 (0.1–0.5) versus 0.5 (0.4–0.6) before transplantation (p < .001). Median (IQR) β‐score was 1 (0–4) (p < .05 when comparing with pre‐transplantation values) and 51.9% recipients had a functional islet graft at 10 years. With a 10‐year follow‐up in a multicentric network, islet transplantation provided sustained improvement of glycemic control and was efficient to prevent severe hypoglycemia in almost 75% of the recipients.
Despite a low rate of insulin independence, islet transplantation in patients with type 1 diabetes continues to yield benefit 10 years after transplantation, providing 50% of recipients with good metabolic control and nearly 75% with freedom from severe hypoglycemia episodes.
Aims
To compare closed‐loop (CL) and open‐loop (OL) systems for glycaemic control in patients with type 1 diabetes (T1D) exposed to real‐life challenging situations (gastronomic dinners or sustained ...physical exercise).
Methods
Thirty‐eight adult patients with T1D were included in a three‐armed randomized pilot trial (Diabeloop WP6.2 trial) comparing glucose control using a CL system with use of an OL device during two crossover 72‐hour periods in one of the three following situations: large (gastronomic) dinners; sustained and repeated bouts of physical exercise (with uncontrolled food intake); or control (rest conditions). Outcomes included time in spent in the glucose ranges of 4.4‐7.8 mmol/L and 3.9‐10.0 mmol/L, and time in hypo‐ and hyperglycaemia.
Results
Time spent overnight in the tight range of 4.4 to 7.8 mmol/L was longer with CL (mean values: 63.2% vs 40.9% with OL; P ≤ .0001). Time spent during the day in the range of 3.9 to 10.0 mmol/L was also longer with CL (79.4% vs 64.1% with OL; P ≤ .0001). Participants using the CL system spent less time during the day with hyperglycaemic excursions (glucose >10.0 mmol/L) compared to those using an OL system (17.9% vs 31.9%; P ≤ .0001), and the proportions of time spent during the day with hyperglycaemic excursions of those using the CL system in the gastronomic dinner and physical exercise subgroups were of similar magnitude to those in the control subgroup (18.1 ± 6.3%, 17.2 ± 8.1% and 18.4 ± 12.5%, respectively). Finally, times spent in hypoglycaemia were short and not significantly different among the groups.
Conclusions
The Diabeloop CL system is superior to OL devices in reducing hyperglycaemic excursions in patients with T1D exposed to gastronomic dinners, or exposed to physical exercise followed by uncontrolled food and carbohydrate intake.
To analyze safety and efficacy of the Diabeloop Generation 1 (DBLG1) hybrid closed-loop artificial pancreas system in patients with type 1 diabetes in real-world conditions.
After a 1-week run-in ...period with their usual pump, 25 patients were provided the commercial DBLG1 system. The results are presented on time in range (TIR) and HbA
over 6 months.
The mean (SD; range) age of patients was 43 (13.8; 25-72) years. At baseline, the mean HbA
and TIR 70-180 mg/dL were, respectively, 7.9% (0.93; 5.6-8.5%) 63 mmol/mol (10; 38-69 mmol/mol) and 53% (16.4; 21-85%). One patient stopped using the system after 2 months. At 6 months, the mean HbA
decreased to 7.1% 54 mmol/mol (
< 0.001) and TIR 70-180 mg/dL increased to 69.7% (
< 0.0001). TIR <70 mg/dL decreased from 2.4 to 1.3% (
= 0.03), and TIR <54 mg/dL decreased from 0.32 to 0.24% (
= 0.42). No serious adverse event was reported during the study.
The ability of the DBLG1 system to significantly improve glycemic control in real-world conditions, without serious adverse events, was confirmed in this follow-up study.
TeleDiab‐2 was a 13‐month randomized controlled trial evaluating the efficacy and safety of two telemonitoring systems to optimize basal insulin (BI) initiation in subjects with inadequately ...controlled type 2 diabetes (HbA1c, 7.5%‐10%). A total of 191 participants (mean age 58.7 years, mean HbA1c 8.9%) were randomized into three groups: group 1(G1, standard care, n = 63), group 2 (G2, interactive voice response system, n = 64) and group 3 (G3, Diabeo‐BI app software, n = 64). The two telemonitoring systems proposed daily adjustments of BI doses, in order to facilitate the achievement of fasting blood glucose (FBG) values targeted at ~100 mg/dL. At 4 months follow‐up, HbA1c reduction was significantly higher in the telemonitoring groups (G2: −1.44% and G3: −1.48% vs. G1: −0.92%; P < 0.002). Moreover, target FBG was reached by twice as many patients in the telemonitoring groups as in the control group, and insulin doses were also titrated to higher levels. No severe hypoglycaemia was observed in the telemonitoring groups and mild hypoglycaemia frequency was similar in all groups. In conclusion, both telemonitoring systems improved glycaemic control to a similar extent, without increasing hypoglycaemic episodes.
Summary
The aim of this study was to better characterise whether sleep habits, eating schedule and physical activity in real‐life are associated with glycaemic control in patients with type 2 ...diabetes. A total of 28 patients (aged 60 years 58; 66, 54% female) with type 2 diabetes treated with basal‐bolus insulin therapy administered by insulin pumps were analysed. Glycaemic data measured by Flash Glucose Monitor System, physical activity and sleep data measured by accelerometer, and meal schedules were simultaneously collated with insulin pump administration data, for 7 days in real‐life. Their respective impact on the time spent in target, in hypoglycaemia, in hyperglycaemia and on glycaemic variability was evaluated. Multiple regressions showed that the total daily dose of meal boluses of insulin was inversely associated with the coefficient of variation (CV; coefficient β = −0.073; 95% confidence interval: −0.130, −0.015; p = 0.016), as well as sleep duration. The higher the sleep duration, the lower the glycaemic variability (coefficient β = −0.012; 95% confidence interval: −0.023, −0.002; p = 0.027). The mean 7 days physical activity of the subjects was very low and was not associated with glycaemic control on the 7 days mean values. However, days with at least 1 hr spent in physical activity higher than 1.5 METs were associated with less glycaemic variability that same day. This real‐life observation highlights the importance of sufficient sleep duration and regular physical activity to lessen the glycaemic variability of patients with type 2 diabetes.
Closed-loop insulin delivery systems are expected to become a standard treatment for patients with type 1 diabetes. We aimed to assess whether the Diabeloop Generation 1 (DBLG1) hybrid closed-loop ...artificial pancreas system improved glucose control compared with sensor-assisted pump therapy.
In this multicentre, open-label, randomised, crossover trial, we recruited adults (aged ≥18 years) with at least a 2 year history of type 1 diabetes, who had been treated with external insulin pump therapy for at least 6 months, had glycated haemoglobin (HbA
) of 10% or less (86 mmol/mol), and preserved hypoglycaemia awareness. After a 2-week run-in period, patients were randomly assigned (1:1) with a web-based system in randomly permuted blocks of two, to receive insulin via the hybrid closed-loop system (DBLG1; using a machine-learning-based algorithm) or sensor-assisted pump therapy over 12 weeks of free living, followed by an 8-week washout period and then the other intervention for 12 weeks. The primary outcome was the proportion of time that the sensor glucose concentration was within the target range (3·9-10·0 mmol/L) during the 12 week study period. Efficacy analyses were done in the modified intention-to-treat population, which included all randomly assigned patients who completed both 12 week treatment periods. Safety analyses were done in all patients who were exposed to either of the two treatments at least once during the study. This trial is registered with ClinicalTrials.gov, number NCT02987556.
Between March 3, 2017, and June 19, 2017, 71 patients were screened, and 68 eligible patients were randomly assigned to the DBLG1 group (n=33) or the sensor-assisted pump therapy group (n=35), of whom five dropped out in the washout period (n=1 pregnancy; n=4 withdrew consent). 63 patients completed both 12 week treatment periods and were included in the modified intention-to-treat analysis. The proportion of time that the glucose concentration was within the target range was significantly higher in the DBLG1 group (68·5% SD 9·4 than the sensor-assisted pump group (59·4% 10·2; mean difference 9·2% 95% CI 6·4 to 11·9; p<0·0001). Five severe hypoglycaemic episodes occurred in the DBLG1 group and three episodes occurred in the sensor-assisted pump therapy group, which were associated with hardware malfunctions or human error.
The DBLG1 system improves glucose control compared with sensor-assisted insulin pumps. This finding supports the use of closed-loop technology combined with appropriate health care organisation in adults with type 1 diabetes.
French Innovation Fund, Diabeloop.
PDF
