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Purpose Real-time continuous glucose monitoring (RT-CGM) provides information on glycemic variability (GV), time in range (TIR), and guidance to avoid hypoglycemia, thereby complimenting HbA1c for diabetes management. We investigated whether GV and TIR were independently associated with chronic and acute diabetes complications. Methods Between September 2014 and January 2017, 515 subjects with type 1 diabetes using sensor-augmented pump therapy were followed for 24 months. The link between baseline HbA1c and CGM-derived glucometrics (TIR [70-180 mg/dL], coefficient of variation [CV], and SD) obtained from the first 2 weeks of RT-CGM use and the presence of complications was investigated. Complications were defined as: composite microvascular complications (presence of neuropathy, retinopathy, or nephropathy), macrovascular complications, and hospitalization for hypoglycemia and/or ketoacidosis. Results Individuals with microvascular complications were older (P < 0.001), had a longer diabetes duration (P < 0.001), a higher HbA1c (7.8 ± 0.9 vs 7.5 ± 0.9%, P < 0.001), and spent less time in range (60.4 ± 12.2 vs 63.9 ± 13.8%, P = 0.022) compared with those without microvascular complication. Diabetes duration (odds ratio [OR] = 1.12 [1.09-1.15], P < 0.001) and TIR (OR = 0.97 [0.95-0.99], P = 0.005) were independent risk factors for composite microvascular complications, whereas SD and CV were not. Age (OR = 1.08 [1.03-1.14], P = 0.003) and HbA1c (OR = 1.80 [1.02-3.14], P = 0.044) were risk factors for macrovascular complications. TIR (OR = 0.97 [0.95-0.99], P = 0.021) was the only independent risk factor for hospitalizations for hypoglycemia or ketoacidosis. Conclusions Lower TIR was associated with the presence of composite microvascular complications and with hospitalization for hypoglycemia or ketoacidosis. TIR, SD, and CV were not associated with macrovascular complications.

Background People with type 1 diabetes can continuously monitor their glucose levels on demand (intermittently scanned continuous glucose monitoring [isCGM]), or in real time (real-time continuous glucose monitoring [rtCGM]). However, it is unclear whether switching from isCGM to rtCGM with alert functionality offers additional benefits. Therefore, we did a trial comparing rtCGM and isCGM in adults with type 1 diabetes (ALERTT1). Methods We did a prospective, double-arm, parallel-group, multicentre, randomised controlled trial in six hospitals in Belgium. Adults with type 1 diabetes who previously used isCGM were randomly assigned (1:1) to rtCGM (intervention) or isCGM (control). Randomisation was done centrally using minimisation dependent on study centre, age, gender, glycated haemoglobin (HbA(1c)), time in range (sensor glucose 3.9-10.0 mmol/L), insulin administration method, and hypoglycaemia awareness. Participants, investigators, and study teams were not masked to group allocation. Primary endpoint was mean between-group difference in time in range after 6 months assessed in the intention-to-treat sample. This trial is registered with ClinicalTrials.gov, NCT03772600. Findings Between Jan 29 and July 30, 2019, 269 participants were recruited, of whom 254 were randomly assigned to rtCGM (n=127) or isCGM (n=127); 124 and 122 participants completed the study, respectively. After 6 months, time in range was higher with rtCGM than with isCGM (59.6% vs 51.9%; mean difference 6.85 percentage points [95% CI 4.36-9.34]; p

Objective: Data on switching from traditional mealtime insulin analogs to fast-acting insulin aspart (Fiasp) in routine clinical practice are sparse. The aim was to evaluate the efficacy and safety of this switch in a “real-world” clinical practice setting in adult people with type 1 diabetes (PWD1) who were using intermittent or real-time continuous glucose monitoring (iCGM or rtCGM) in Belgium. Research Design and Methods: Data from 438 adult PWD1 (60% men, age 44.6±16.1 y, duration of diabetes 21.5±14.0 y, iCGM/rtCGM: 391/47, multiple daily injections/pump: 409/29), who initiated Fiasp between January 2018 and May 2020 were retrospectively analyzed. The primary endpoint was the evolution of time in range (TIR, 70-180 mg/dl) at 6 (n=416) and 12 months (n=380). Secondary endpoints included change in HbA1c, BMI, insulin doses, time below range (T180 and T>250 mg/dl). Results: TIR improved from 50.3±15.6% to 54.3±15.1% at 6 months and 55.5±15.2% at 12 months (p180 mg/dl decreased from 42.3±16.7% to 38.1±16.5% and to 37.7±16.9% (p250 mg/dl evolved from 16.5±12.8% to 13.8±11.8% and to 13.1±12.5% (p Conclusions: In a Belgian real-world setting of adult PWD1, switching to Fiasp resulted in a 5% increased TIR, corresponding to 75 min/day, in combination with less time spent below and above range. Disclosure L. Billion: None. F. W. Peiffer: None. K. P. Van dessel: None. C. Mathieu: Advisory Panel; Self; Novo Nordisk, Sanofi, Merck Sharp and Dohme Ltd., Eli Lilly and Company, Novartis, AstraZeneca, Boehringer Ingelheim, Roche, Medtronic, ActoBio Therapeutics, Pfizer, Insulet and Zealand Pharma, Research Support; Self; Medtronic, Novo Nordisk, Sanofi and ActoBio Therapeutics, Speaker’s Bureau; Self; Novo Nordisk, Sanofi, Eli Lilly and Company, Boehringer Ingelheim, AstraZeneca and Novartis. P. Gillard: None. C. De block: Advisory Panel; Self; A. Menarini Diagnostics, Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim , Eli Lilly and Company, MSD, Novartis AG, Novo Nordisk, Roche Diagnostics, Sanofi, Research Support; Self; AstraZeneca, Novo Nordisk, Speaker’s Bureau; Self; A. Menarini Diagnostics, Abbott Diagnostics, Boehringer Ingelheim , Eli Lilly and Company, Novo Nordisk, Sanofi. S. Charleer: None. L. Verbraeken: None. M. Sterckx: None. K. Vangelabbeek: None. N. De block: None. C. Janssen: None. N. Bolsens: Advisory Panel; Self; Medtronic. E. L. Dirinck: None.

Purpose To investigate whether diabetes knowledge and health literacy impact glycemic control after 1 year of intermittently scanned continuous glucose monitoring (isCGM) in people with type 1 diabetes ≥ 16 years. Methods In this prospective real-world cohort study, we assessed diabetes knowledge using a new 10-item questionnaire [Patient Education and Knowledge (PEAK)] and health literacy using the validated 6-item Newest-Vital Sign-D (NVS-D) questionnaire. Primary endpoint was association between PEAK score and change in hemoglobin A1c (HbA1c). Secondary endpoints were link between NVS-D score and change in HbA1c and that between time spent in/above/below range and PEAK/NVS-D scores. Results 851 subjects were consecutively recruited between July 2016 and July 2018. Median PEAK score was 8 (range: 0-10), and median NVS-D score was 6 (range 0-6). HbA1c evolved from 7.9% (7.8%-8.0%), 63 (62-64) mmol/mol, at start to 7.7% (7.6%-7.7%), 61 (60-61) mmol/mol (P Conclusions isCGM reduced time in hypoglycemia, and HbA1c evolved favorably. Our findings suggest that diabetes and health literacy affect glucometrics, emphasizing the importance of education.

AIM: To evaluate the efficacy and safety of switching from traditional mealtime insulins to fast-acting insulin aspart (Fiasp) in a "real-world" clinical practice setting in adult people with type 1 diabetes (PWD1) who were using intermittently scanned or real-time continuous glucose monitoring (isCGM or rtCGM, respectively). MATERIALS AND METHODS: Data from 438 adult PWD1 (60% men, age 44.6 ± 16.2 years, diabetes duration 21.5 ± 14.0 years, isCGM/rtCGM: 391/47, multiple daily injections/continuous subcutaneous insulin infusion: 409/29), who initiated Fiasp from January 2018 to May 2020, were analysed. The primary objective was the evolution of time in range (TIR; 70-180 mg/dL) at 6 and 12 months. Secondary objectives included change in HbA1c, body mass index (BMI), insulin doses, time below range (180 and >250 mg/dL). RESULTS: TIR improved from 50.3% ± 15.6% to 54.3% ± 15.1% at 6 months (n = 425) and to 55.5% ± 15.2% at 12 months (n = 385) (P

OBJECTIVE: We undertook a 24-month prospective observational single-center real-world trial to study impact of access to intermittently scanned continuous glucose monitoring (isCGM) on quality of life (QOL) and glycemic control of youth with type 1 diabetes (T1D). METHODS: Between September 2016 and November 2017, 138 children and adolescents with T1D were recruited. Demographic, metabolic, and QOL data were collected during 24 months of routine follow-up. Primary endpoint was the evolution of QOL, with secondary outcomes change in HbA1c, occurrence of acute diabetes complications, and school absenteeism. RESULTS: Ninety-two percent of participants found isCGM more user-friendly than capillary finger-stick tests and had high treatment satisfaction, without change in diabetes-specific QOL. HbA1c significantly increased from 7.2% (7.0-7.3) (55 mmol/mol [53-56]) at baseline to 7.6% (7.4-7.8) (60 mmol/mol [57-62]) at 12 months (P

OBJECTIVE In 2016, nationwide reimbursement of intermittently scanned continuous glucose monitoring (isCGM) for people living with type 1 diabetes treated in specialist diabetes centers was introduced in Belgium. We undertook a 12-month prospective observational multicenter real-world study to investigate impact of isCGM on quality of life and glycemic control. RESEARCH DESIGN AND METHODS Between July 2016 and July 2018, 1,913 adults with type 1 diabetes were consecutively recruited in three specialist diabetes centers. Demographic, metabolic, and quality of life data were collected at baseline, 6 months, and 12 months of standardized clinical follow-up. The primary end point was evolution of quality of life from baseline to 12 months. Secondary outcome measures were, among others, change in HbA1c, time spent in different glycemic ranges, occurrence of acute diabetes complications, and work absenteeism. RESULTS General and diabetes-specific quality of life was high at baseline and remained stable, whereas treatment satisfaction improved (P < 0.0001). Admissions for severe hypoglycemia and/or ketoacidosis were rare in the year before study (n = 63 out of 1,913; 3.3%), but decreased further to 2.2% (n = 37 out of 1,711; P = 0.031). During the study, fewer people reported severe hypoglycemic events (n = 280 out of 1,913 [14.6%] vs. n = 134 out of 1,711 [7.8%]; P < 0.0001) or hypoglycemic comas (n = 52 out of 1,913 [2.7%] vs. n = 18 out of 1,711 [1.1%]; P = 0.001) while maintaining HbA1c levels. Fewer people were absent from work (n = 111 out of 1,913 [5.8%] vs. n = 49 out of 1,711 [2.9%]; P < 0.0001). Time spent in hypoglycemia significantly decreased in parallel with less time in range and more time in hyperglycemia. Eleven percent (n = 210) of participants experienced skin reactions, leading to stopping of isCGM in 22 participants (1%). CONCLUSIONS Nationwide unrestricted reimbursement of isCGM in people with type 1 diabetes treated in specialist diabetes centers results in higher treatment satisfaction, less severe hypoglycemia, and less work absenteeism, while maintaining quality of life and HbA1c.

Background: Long-term real-life data of SAP in pediatric T1D patients are scarce. Objectives: To assess the impact of 12 months use of SAP in a nationwide study of pediatric T1D patients on HbA1c, hypoglycemia and quality of life1 according to age. Methods: Between 12/2014 and 02/2017, 75 children entered Belgian reimbursement system for SAP and were followed for 12 months. Study endpoints included change in HbA1c at 0-4-8-12 months; time-in-hypoglycemia ( Results: Seventy-three patients used SAP for 12 months. Baseline HbA1c (7.2±0.7%) decreased to 7.1±0.8% at 4 months (p=0.02), remained stable at 8 months (p=0.03) and 12 months (p=0.15). In pubertal children (n=29) baseline was 7.1±0.7%. It decreased to 6.8±0.7% at 4 months (p=0.003), increased to 7.0±0.8% at 8 months (p=0.02) and to 7.1±0.8% at 12 months (p=0.20). In prepubertal children (n=43) baseline Hb1Ac was 7.3±0.7%; and evolved towards 7.1±0.8% at 12 months (p=0.40). In pubertal children, time-in-hypoglycemia decreased from 7.1±6.9% to 5.7±5.1% (p=0.06) the first year, while time-in-severe-hypoglycemia did not significantly change (1.0±1.7% to 1.3±2.0%). In prepubertal children, both parameters did not significantly change (5,9±5,4% to 5,6±3,4% - 0,8±1,4% to 1,1±1,4%). In pubertal children and their parents, QoL did not significantly change. In prepubertal children, satisfaction scores improved after 12months from 67±12 to 70±9 (p=0.026). Conclusions: One year reimbursement of SAP in pediatric T1D patients improved HbA1c in the first 8 months in all; tended to decrease hypoglycemia in pubertal children; while improving QoL in prepubertal children. 1RESCUE-NCT02601729. 2Impact, satisfaction, worry (children) and parents. Disclosure F. De Ridder: None. S. Jacobs: None. S. Charleer: Other Relationship; Self; Roche Diabetes Care. P. Gillard: None. K. Casteels: None. S. Van Aken: None. I. Gies: None. G. Massa: None. P.A. Lysy: None. K. Logghe: None. M. Lebrethon: None. S. Depoorter: None. K.J. Ledeganck: None. C. De Block: None. M. den Brinker: None.

CONTEXT: Randomized controlled trials evaluating real-time continuous glucose monitoring (RT-CGM) patients with type 1 diabetes (T1D) show improved glycemic control, but limited data are available on real-world use. OBJECTIVE: To assess impact of RT-CGM in real-world settings on glycemic control, hospital admissions, work absenteeism, and quality of life (QOL). DESIGN: Prospective, observational, multicenter, cohort study. PARTICIPANTS: A total of 515 adults with T1D on continuous subcutaneous insulin infusion (CSII) therapy starting in the Belgian RT-CGM reimbursement program. INTERVENTION: Initiation of RT-CGM reimbursement. MAIN OUTCOME MEASURE: Hemoglobin A1c (HbA1c) evolution from baseline to 12 months. RESULTS: Between September 1, 2014, and December 31, 2016, 515 adults entered the reimbursement system. Over this period, 417 (81%) patients used RT-CGM for at least 12 months. Baseline HbA1c was 7.7 ± 0.9% (61 ± 9.8 mmol/mol) and decreased to 7.4 ± 0.8% (57 ± 8.7 mmol/mol) at 12 months (P < 0.0001). Subjects who started RT-CGM because of insufficient glycemic control showed stronger decrease in HbA1c at 4, 8, and 12 months compared with patients who started because of hypoglycemia or pregnancy. In the year preceding reimbursement, 16% of patients were hospitalized for severe hypoglycemia or ketoacidosis in contrast to 4% (P < 0.0005) the following year, with decrease in admission days from 54 to 18 per 100 patient years (P < 0.0005). In the same period, work absenteeism decreased and QOL improved significantly, with strong decline in fear of hypoglycemia. CONCLUSION: Sensor-augmented pump therapy in patients with T1D followed in specialized centers improves HbA1c, fear of hypoglycemia, and QOL, whereas work absenteeism and admissions for acute diabetes complications decreased. TRIAL REGISTRATION: ClinicalTrials.gov NCT02601729.

Nowadays, most Belgian patients with type 1 diabetes use flash glucose monitoring (FreeStyle Libre [FSL]; Abbott Diabetes Care, Alameda, California) to check their glucose values, but some patients find the sensor on the upper arm too visible. The aim of the present study was to compare the accuracy and precision of FSL sensors when placed on different sites. A total of 23 adults with type 1 diabetes used three FSL sensors simultaneously for 14 days on the upper arm, abdomen and upper thigh. FSL measurements were compared with capillary blood glucose (BG) measurements obtained with a built-in FSL BG meter. The aggregated mean absolute relative difference was 11.8 ± 12.0%, 18.5 ± 18.4% and 12.3 ± 13.8% for the arm, abdomen (P = .002 vs arm) and thigh (P = .5 vs arm), respectively. Results of Clarke error grid analysis for the arm and thigh were similar (zone A: 84.9% vs 84.5%; P = .6), while less accuracy was seen for the abdomen (zone A: 69.4%; P = .01). Apart from the first day, the accuracy of FSL sensors on the arm and thigh was more stable across the 14-day wear duration than accuracy of sensors on the abdomen, which deteriorated mainly during week 2 (P < .0005). The aggregated precision absolute relative difference was markedly lower for the arm/thigh (10.9 ± 11.9%) compared with the arm/abdomen (20.9 ± 22.8%; P = .002). Our results indicate that the accuracy and precision of FSL sensors placed on the upper thigh are similar to the upper arm, whereas the abdomen performed unacceptably poorly.