Search

Aims: To reassess the 6‐month efficacy and to assess the 12‐month sustained efficacy of the MiniMed™ 780G advanced hybrid closed‐loop automated insulin delivery (AID) system compared to multiple daily injections plus intermittently scanned glucose monitoring (MDI+isCGM) in people with type 1 diabetes not meeting glucose targets. Methods: The ADAPT study was a prospective, multicentre, open‐label, randomized control trial in people with type 1 diabetes, with a glycated haemoglobin (HbA1c) concentration of at least 8.0% (64 mmol/mol), on MDI+isCGM therapy. After a 6‐month study phase, participants randomized at baseline to MDI+isCGM switched to AID (SWITCH) while the others continued AID therapy (SUSTAIN) for an additional 6 months. The primary endpoint of this continuation phase was the within‐group change in mean HbA1c between 6 and 12 months, with superiority in the SWITCH group and noninferiority in the SUSTAIN group (ClinicalTrials.gov: NCT04235504). Results: A total of 39 SWITCH and 36 SUSTAIN participants entered the continuation phase. In the SWITCH group, HbA1c was significantly decreased by −1.4% (95% confidence interval [CI] −1.7% to −1.1%; P < 0.001) from a mean ± SD of 8.9% ± 0.8% (73.9 ± 8.6 mmol/mol) at 6 months to 7.5% ± 0.6% (58.5 ± 6.9 mmol/mol) at 12 months. Mean HbA1c increased by 0.1% (95% CI −0.05% to +0.25%), from 7.3% ± 0.6% (56.5 ± 6.7 mmol/mol) to 7.4% ± 0.8% (57.7 ± 9.1 mmol/mol) in the SUSTAIN group, meeting noninferiority criteria. Three severe hypoglycaemia events occurred in two SWITCH participants during the continuation phase. Conclusion: ADAPT study phase glycaemic improvements were reproduced and sustained in the continuation phase, supporting the early adoption of AID therapy in people with type 1 diabetes not meeting glucose targets on MDI therapy. [ABSTRACT FROM AUTHOR]

Copyright of Biologie Aujourd'hui is the property of EDP Sciences and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

A post hoc analysis of the Diabeloop WP7 multicentre, randomized controlled trial was performed to investigate the efficacy of the Diabeloop Generation‐1 (DBLG1) closed‐loop system in controlling the hypoglycaemia induced by physical activity (PA) in real‐life conditions. Glycaemic outcomes were compared between days with and without PA in 56 patients with type 1 diabetes (T1D) using DBLG1 for 12 weeks. After the patient announces a PA, DBLG1 reduces insulin delivery and, if necessary, calculates the amount of preventive carbohydrates (CHO). Daily time spent in the interstitial glucose range less than 70 mg/dL was not significantly different between days with and without PA (2.0% ± 1.5% vs. 2.2% ± 1.1%), regardless of the intensity or duration of the PA. Preventive CHO intake recommended by the system was significantly higher in days with PA (41.1 ± 35.5 vs. 21.8 ± 28.5 g/day; P <.0001), and insulin delivery was significantly lower (31.5 ± 10.5 vs. 34.0 ± 10.5 U/day; P <.0001). The time spent in hyperglycaemia and the glycaemic variation coefficient increased significantly on days with PA. In real‐life conditions, the use of DBLG1 avoids PA‐induced hypoglycaemia. Insulin adjustments and preventive CHO recommendation may explain this therapeutic benefit. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Summary: The microbiological safety of islet preparations is paramount. Preservation medium contamination is frequent, and its impact on islet yield and function remains unclear. Microbiological samples collected during islet isolations from 2006 to 2016 were analyzed and correlated to isolation and allo‐ and autotransplantation outcomes. Microbial contamination of preservation medium was found in 64.4% of processed donor pancreases (291/452). We identified 464 microorganisms including Staphylococcus (253/464, 54.5%), Streptococcus (31/464, 6.7%), and Candida species (25/464, 5.4%). Microbial contamination was associated with longer warm and cold ischemia times and lower numbers of postpurification islet equivalents, purity, transplant rate, and stimulation index (all P < 0.05). Six percent of the preparations accepted for transplantation showed microbial contamination after isolation (12/200); 9 of 12 were Candida species. Six patients were transplanted with a sample with late microbial growth discovered after the infusion. Insulin independence rate was not affected. This risk of transplanting a contaminated islets preparation was reduced by half following the implementation of an additional sampling after 24 h of islet culture. Pancreas preservation fluid microbial contamination is associated with lower transplant rate and poorer in vitro function, but not with changes in graft survival. Culture medium testing 1 day after isolation reduces the risk of incidental transplantation with contaminated islets. [ABSTRACT FROM AUTHOR]

OBJECTIVE To describe the 5-year outcomes of islet transplantation within the Swiss-French GRAGIL Network. RESEARCH DESIGN AND METHODS Retrospective analysis of all subjects enrolled in the GRAGIL-1c and GRAGIL-2 islet transplantation trials. Parameters related to metabolic control, graft function, and safety outcomes were studied. RESULTS Forty-four patients received islet transplantation (islet transplantation alone [ITA] 24 patients [54.5%], islet after kidney [IAK] transplantation 20 patients [45.5%]) between September 2003 and April 2010. Recipients received a total islet mass of 9,715.75 ± 3,444.40 IEQ/kg. Thirty-four patients completed a 5-year follow-up, and 10 patients completed a 4-year follow-up. At 1, 4, and 5 years after islet transplantation, respectively, 83%, 67%, and 58% of the ITA recipients and 80%, 70%, and 60% of the IAK transplant recipients reached HbA1c under 7% (53mmol/mol) and were free of severe hypoglycemia, while none of the ITA recipients and only 10% of the IAK transplant recipients met this composite criterion at the preinfusion stage. Thirty-three of 44 patients (75%) experienced insulin independence during the entire follow-up period, with a median duration of insulin independence of 19.25 months (interquartile range 2-58). Twenty-nine of 44 recipients (66%) exhibited at least one adverse event; 18 of 55 adverse events (33%) were possibly related to immunosuppression; and complications related to the islet infusion (n = 84) occurred in 10 recipients (11.9%). CONCLUSIONS In a large cohortwith a 5-year follow-up and in amulticenter network setting, islet transplantation was safe and efficient in restoring good and lasting glycemic control and preventing severe hypoglycemia in patients with type 1 diabetes. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the evolution of glycemic outcomes in patients living with type 1 diabetes (T1D) after 1 year of use of the MiniMed 780G advanced hybrid closed-loop (AHCL) system. Methods: We conducted an observational, retrospective, multicentric study in 20 centers in France. The primary objective was to evaluate the improvement in glycemic control after 1-year use of AHCL. The primary endpoint was the variation of time in range (TIR) between pre-AHCL and after 1-year use of AHCL. Secondary objectives were to analyze the glycemic outcomes after 3, 6, and 12 months of AHCL use, the safety, and the long-term observance of AHCL. Results: Two hundred twenty patients were included, and 200 were analyzed for the primary endpoint. 92.7% of patients continued to use AHCL. After 1 year of use of AHCL, TIR was 72.5% ± 10.6% (+9.1%; 95% confidence interval [CI] [7.6–10.5] compared to pre-AHCL initiation, P < 0.001), HbA1c 7.1% ± 0.7% (−0.5%; 95% CI [−0.6 to −0.4]; P < 0.001), time below range 2.0% [1.0; 3.0] (0.0% [−2.0; 0.0], P < 0.001), and time above range 24.8% ± 10.9% (−7.3%; 95% CI [−8.8 to −5.7]; P < 0.001). More patients achieved the glycemic treatment goals of HbA1c <7.0% (45.1% vs. 18.1%, P < 0.001) and TIR >70% (59.0% vs. 29.5% P < 0.001) when compared with pre-AHCL. Five patients experienced severe hypoglycemia events and two patients experienced ketoacidosis. Conclusion: After 1 year of use of AHCL, people living with T1D safely improved their glucose control and a higher proportion of them achieved optimal glycemic control. [ABSTRACT FROM AUTHOR]

The document titled "Correction to: Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed™ Glycemic Control and Quality of Life Study" discusses corrections made to a previous article. It acknowledges various study investigators and provides updated information on the authors and their affiliations. The article is open access and licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. [Extracted from the article]

Introduction: The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France.Individuals aged ≥ 7 years with T1D were enrolled. A 14-day run-in phase in Manual mode preceded a 12-month study phase using Auto mode. The primary endpoint was absolute change in time in range (TIR) from baseline to 6 months. Secondary endpoints included changes in glycemic targets, glycated hemoglobin (HbA1c), and hypoglycemia. PROs included treatment satisfaction, quality of life (QoL), and fear of hypoglycemia.Two-hundred seventy participants formed the intent-to-treat population at 6 months. TIR increased by 11.8 percentage points (standard deviation [SD] 8.96, 95% confidence interval 10.7 to 12.9, p < 0.0001), from 61.9% (SD 11.0) to 73.7% (SD 7.4), equivalent to 2.8 h per day more in range. Time < 70 mg/dL decreased by 1.5 percentage points (p < 0.0001), from 4.0% to 2.5%. All glycemic parameters significantly improved. HbA1c decreased by 0.52% and 0.42% at 6 and 12 months, respectively. More patients met glycemic targets, while severe hypoglycemia was reduced. At 12 months, treatment satisfaction increased across age groups, and QoL improved in adults. Fear of hypoglycemia decreased in adults and children.In France, people with T1D initiating the MiniMed™ 780G system demonstrated sustained TIR and HbA1c improvements. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction.ClinicalTrials.gov identifier, NCT04308291.Methods: The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France.Individuals aged ≥ 7 years with T1D were enrolled. A 14-day run-in phase in Manual mode preceded a 12-month study phase using Auto mode. The primary endpoint was absolute change in time in range (TIR) from baseline to 6 months. Secondary endpoints included changes in glycemic targets, glycated hemoglobin (HbA1c), and hypoglycemia. PROs included treatment satisfaction, quality of life (QoL), and fear of hypoglycemia.Two-hundred seventy participants formed the intent-to-treat population at 6 months. TIR increased by 11.8 percentage points (standard deviation [SD] 8.96, 95% confidence interval 10.7 to 12.9, p < 0.0001), from 61.9% (SD 11.0) to 73.7% (SD 7.4), equivalent to 2.8 h per day more in range. Time < 70 mg/dL decreased by 1.5 percentage points (p < 0.0001), from 4.0% to 2.5%. All glycemic parameters significantly improved. HbA1c decreased by 0.52% and 0.42% at 6 and 12 months, respectively. More patients met glycemic targets, while severe hypoglycemia was reduced. At 12 months, treatment satisfaction increased across age groups, and QoL improved in adults. Fear of hypoglycemia decreased in adults and children.In France, people with T1D initiating the MiniMed™ 780G system demonstrated sustained TIR and HbA1c improvements. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction.ClinicalTrials.gov identifier, NCT04308291.Results: The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France.Individuals aged ≥ 7 years with T1D were enrolled. A 14-day run-in phase in Manual mode preceded a 12-month study phase using Auto mode. The primary endpoint was absolute change in time in range (TIR) from baseline to 6 months. Secondary endpoints included changes in glycemic targets, glycated hemoglobin (HbA1c), and hypoglycemia. PROs included treatment satisfaction, quality of life (QoL), and fear of hypoglycemia.Two-hundred seventy participants formed the intent-to-treat population at 6 months. TIR increased by 11.8 percentage points (standard deviation [SD] 8.96, 95% confidence interval 10.7 to 12.9, p < 0.0001), from 61.9% (SD 11.0) to 73.7% (SD 7.4), equivalent to 2.8 h per day more in range. Time < 70 mg/dL decreased by 1.5 percentage points (p < 0.0001), from 4.0% to 2.5%. All glycemic parameters significantly improved. HbA1c decreased by 0.52% and 0.42% at 6 and 12 months, respectively. More patients met glycemic targets, while severe hypoglycemia was reduced. At 12 months, treatment satisfaction increased across age groups, and QoL improved in adults. Fear of hypoglycemia decreased in adults and children.In France, people with T1D initiating the MiniMed™ 780G system demonstrated sustained TIR and HbA1c improvements. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction.ClinicalTrials.gov identifier, NCT04308291.Conclusion: The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France.Individuals aged ≥ 7 years with T1D were enrolled. A 14-day run-in phase in Manual mode preceded a 12-month study phase using Auto mode. The primary endpoint was absolute change in time in range (TIR) from baseline to 6 months. Secondary endpoints included changes in glycemic targets, glycated hemoglobin (HbA1c), and hypoglycemia. PROs included treatment satisfaction, quality of life (QoL), and fear of hypoglycemia.Two-hundred seventy participants formed the intent-to-treat population at 6 months. TIR increased by 11.8 percentage points (standard deviation [SD] 8.96, 95% confidence interval 10.7 to 12.9, p < 0.0001), from 61.9% (SD 11.0) to 73.7% (SD 7.4), equivalent to 2.8 h per day more in range. Time < 70 mg/dL decreased by 1.5 percentage points (p < 0.0001), from 4.0% to 2.5%. All glycemic parameters significantly improved. HbA1c decreased by 0.52% and 0.42% at 6 and 12 months, respectively. More patients met glycemic targets, while severe hypoglycemia was reduced. At 12 months, treatment satisfaction increased across age groups, and QoL improved in adults. Fear of hypoglycemia decreased in adults and children.In France, people with T1D initiating the MiniMed™ 780G system demonstrated sustained TIR and HbA1c improvements. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction.ClinicalTrials.gov identifier, NCT04308291.Trial Registration: The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France.Individuals aged ≥ 7 years with T1D were enrolled. A 14-day run-in phase in Manual mode preceded a 12-month study phase using Auto mode. The primary endpoint was absolute change in time in range (TIR) from baseline to 6 months. Secondary endpoints included changes in glycemic targets, glycated hemoglobin (HbA1c), and hypoglycemia. PROs included treatment satisfaction, quality of life (QoL), and fear of hypoglycemia.Two-hundred seventy participants formed the intent-to-treat population at 6 months. TIR increased by 11.8 percentage points (standard deviation [SD] 8.96, 95% confidence interval 10.7 to 12.9, p < 0.0001), from 61.9% (SD 11.0) to 73.7% (SD 7.4), equivalent to 2.8 h per day more in range. Time < 70 mg/dL decreased by 1.5 percentage points (p < 0.0001), from 4.0% to 2.5%. All glycemic parameters significantly improved. HbA1c decreased by 0.52% and 0.42% at 6 and 12 months, respectively. More patients met glycemic targets, while severe hypoglycemia was reduced. At 12 months, treatment satisfaction increased across age groups, and QoL improved in adults. Fear of hypoglycemia decreased in adults and children.In France, people with T1D initiating the MiniMed™ 780G system demonstrated sustained TIR and HbA1c improvements. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction.ClinicalTrials.gov identifier, NCT04308291. [ABSTRACT FROM AUTHOR]