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ORAL PRESENTATION SESSION
Date
Wed, 02.06.2021
Session Type
ORAL PRESENTATION SESSION
Session Time
18:35 - 20:05
Room
Hall A
ORAL PRESENTATION SESSION

REAL WORLD COST OUTCOMES WITH DIABETES TECHNOLOGY USAGE AMONG ADULTS WITH TYPE 1 OR TYPE 2 DIABETES USING RAPID-ACTING INSULIN

Abstract

Background and Aims

We aimed to determine the 1-year medical costs associated with initiation of a continuous glucose monitor (CGM) or insulin pump.

Methods

Using the IBM MarketScan database, we included people with diabetes (PwD) ≥40 years old using rapid-acting insulin who initiated a CGM or a pump (index date) between 2015-2017. A third cohort, a control group, were blood glucose monitor (BGM) users. Continuous enrollment was required in the 12 months before (baseline) and after (follow-up) index date. Mean total medical costs, excluding device-related costs, are reported as unadjusted values. Adjusted follow-up costs were calculated by fitting a generalized linear model with gamma distribution and log link.

Results

table.jpgPwD meeting all criteria (n=7,700) were assigned to one of the 3 cohorts (table). For CGM and Pump cohorts, unadjusted follow-up costs were higher than baseline. After multivariable adjustment, in the first year after initiation CGM was associated with $2038 in savings compared to BGM (p=0.0076) while pump was associated with $1786 higher costs (p=0.0039). Significant covariates in the models included baseline cost, age, diabetes type (and interaction with age), and polypharmacy.

Conclusions

During the follow-up period, the unadjusted medical costs appear lower than BGM for both CGM and Pump, but multivariable adjustment yielded medical cost savings only for CGM use. Economic benefits might be observable sooner for CGMs than for pumps. Future work should extend the analyses to longer follow-up periods, characterize the source(s) of the incremental savings/costs, and evaluate whether the results differ for newer generations of devices.

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ORAL PRESENTATION SESSION

COMPARING REAL-TIME AND INTERMITTENTLY SCANNED CONTINUOUS GLUCOSE MONITORING IN ADULTS WITH TYPE 1 DIABETES: THE SIX-MONTH MULTICENTER RANDOMIZED CONTROLLED ALERTT1 TRIAL

Abstract

Background and Aims

It is currently unclear whether switching from isCGM to rtCGM with alert functionality offers additional benefits for adults with type 1 diabetes (T1D).

Methods

This multicenter, open label, randomized controlled trial compared 6-month rtCGM use (Dexcom G6; n=127) with isCGM (Abbott FreeStyle Libre; n=127) in adults with T1D previously using isCGM. Primary endpoint was time in range (TIR; 70-180 mg/dL). The trial was also powered for key secondary endpoints HbA1c, time <54 mg/dL, and Hypoglycemia Fear Survey worry (HFS-worry) score. Sensor-glucose data were measured with (blinded) Dexcom G6 sensors in both groups. Groups (rtCGM/isCGM) were comparable in terms of baseline TIR (52.5%/51.3%), age (42.8 years/43.0 years), HbA1c (7.4%/7.4%), CSII use (18.9%/19.7%), and hypoglycemia unawareness (18.9%/15.7%; based on Clarke score).

Results

After six months, participants on rtCGM spent more TIR compared to isCGM users (59.6% vs. 51.9%; P<0.0001), corresponding to 99 minutes/day. HbA1c was 0.36% (95%CI -0.48,-0.24; P<0.0001) lower compared to isCGM, while time <54 mg/dL differed by 0.35% (95%CI -0.61,-0.10; P=0.007) and HFS-worry by 2.62 points (95%CI -4.52,-0.71; P=0.0071). Compared to isCGM, more people on rtCGM achieved consensus targets for TIR (28.2% vs. 14.9%; P=0.0017), time >180 mg/dL (24.2% vs. 12.4%; P=0.008), time <54 mg/dL (85.5% vs. 73.6%; P=0.034), HbA1c (48.8% vs. 33.1%; P=0.0003), and HbA1c without severe hypoglycemia (48.0% vs. 32.2%; P=0.0004). Scores on treatment satisfaction questionnaires were higher in rtCGM users (P<0.0001).

Conclusions

In an unselected group of adults with T1D, switching from isCGM to rtCGM with alerts significantly improved time in range, HbA1c, time <54 mg/dL, and hypoglycemia worry.

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ORAL PRESENTATION SESSION

ASSOCIATION OF MACRONUTRIENTS INTAKE WITH CGM-BASED TIME IN RANGE IN CHILDREN WITH T1D

Abstract

Background and Aims

To evaluate the association between clinical factors and macronutrients intake with CGM-based time in range (TIR) in children with T1D.

Methods

A multi-center cross-sectional study recruited children with T1D, aged 2-17y, HbA1c < 86 mmol/mol, using CGM, during Jan 2019-Jan 2020 in Italy. Diet intake was collected through three day weighed food diaries. Nutrients were evaluated as percentages of total intake and summarized as median and (IQR). TIR was considered at target if the percentage of readings and time 70-180 mg/dL was higher than 70%. Clinical and nutritional factors associated to TIR at target were analysed using multiple logistic regression, results were expressed as OR and 90%CI.

Results

Data were available for 197 children, 53% male, 47% using CSII, median age 11.6y (8.6-14.3), HbA1c 55 mmol/mol (48-61). Median nutrients intake was Protein, P 16.9% (14.4-19), SFA 9.6% (7.8-10.9), polyunsaturated fatty acid, PUFA 10.3% (7-14.9), monounsaturated fatty acid, MUFA 16.4% (13.8-19.4), carbohydrates, CHO 45.9% (42.3-49.1). TIR at target was observed in 28% of participants; median TIR was 60% (47-71). Increasing diabetes duration and complex CHO assumption significantly reduced the probability to reach TIR>70%. Use of CHO counting, and higher fat consumption were associated with an increase probability to achieve TIR>70%.

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Conclusions

Less than 30% of the observed population reached the TIR>70%. Both clinical and nutritional factors are associated with TIR at target. This study highlights the role of CHO counting and macronutrient intake in modulating CGM-based glycemic targets in children and adolescents with T1D.

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ORAL PRESENTATION SESSION

FREQUENCY OF FLASH GLUCOSE MONITORING IN RELATION TO GLUCOSE METRICS: REAL-WORLD DATA FROM SAUDI ARABIA

Abstract

Background and Aims

The FreeStyle Libre® flash glucose monitoring system is a sensor-based glucose monitor. The aim of this real-world data study was to analyze glucose metrics from FreeStyle Libre® in relation to scanning frequency in Saudi Arabia.

Methods

Anonymized data from FreeStyle Libre® glucose readers from Saudi Arabia was analyzed for the period October 2015 to June 2020. Sensors, grouped per reader, were required to have ≥120 hours of operation. Readers were rank-ordered by scanning frequency into quartiles. Differences in estimated A1c (eA1c), time in range (TIR), time in hypo- and hyperglycemia, and glucose variation metrics were analyzed in relation to scanning frequency.

Results

A total of 6097 readers, 35,747 sensors and 40 million automatic glucose measurements were analyzed. Patients in the lowest scanning frequency quartile (Q1, mean 5.2 scans/day) had a mean eA1C of 9.77% versus 8.47% (p<0.0001) for the highest scanning frequency quartile (Q4, mean 32.0 scans/day). Mean TIR was 32.8% for Q1 versus 46.4% (p<0.0001) for Q4. Median time below 54 and 70 mg/dL were 1.08% and 3.31% for Q1 versus 0.41% (p<0.05) and 2.31% (p<0.05) for Q4. Mean time above 180 mg/dL was 62.0% for Q1 versus 49.6% (p<0.0001) for Q4. Mean glucose standard deviation and coefficient of variation were 94.9 mg/dL and 41.3% for Q1 versus 75.0 mg/dL (p<0.0001) and 38.2% (p<0.0001) for Q4.

Conclusions

Analysis of real-world data demonstrates that higher scanning frequency in FreeStyle Libre® users is associated with lower eA1c, greater TIR, less time in hypo- and hyperglycemia and lower glucose variation.

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ORAL PRESENTATION SESSION

CONTINUOUS GLUCOSE MONITORING AND CLINICAL OUTCOMES AMONG PATIENTS WITH TYPE 1 DIABETES AND COVID-19: A U.S. BASED MULTI-CENTER OBSERVATIONAL STUDY

Abstract

Background and Aims

Continuous glucose monitoring (CGM) improves glycemic control and reduces complications in patients with type 1 diabetes (T1D). This study examines the frequency of diabetic ketoacidosis (DKA) and hospitalization among patients with T1D and COVID-19 and CGM use.

Methods

This analysis included all patients with T1D who tested positive for COVID-19 (n=241) in the T1D Exchange COVID-19 Registry. Data for the registry was collected using an online survey tool. Healthcare teams from 52 endocrinology clinics across the U.S. completed the survey using electronic medical records between April and September 2020.

Results

Of the 241 patients included in this analysis, 53% were CGM users and 47% were CGM non-users. CGM non-users were more likely to be on public insurance compared to CGM users (68% vs. 34%). HbA1c in the CGM group was lower compared to non-users (Median [IQR],%: 8.1 [2.6] vs 10.0 [3.3] [p<0.001]), and DKA was less frequent for CGM users relative to the non-users (9% vs 36%) [p<0.001]. Further, patients who did not use CGM were more likely to be hospitalized (33% vs 13%) [p<0.001] or need ICU care [30% vs.6%) [p<0.001] than patients who used CGM.cgm_table.png

Conclusions

Patients with T1D infected with COVID-19 who used a CGM device had lower rates of adverse clinical outcomes than patients who did not use CGM.

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ORAL PRESENTATION SESSION

REAL-TIME CONTINUOUS GLUCOSE MONITORING VERSUS SELF MONITORING OF BLOOD GLUCOSE IN TYPE 1 DIABETES: REAL-WORLD DATA FROM A LARGE U.S. MULTI-CENTER STUDY

Abstract

Background and Aims

The management of type 1 diabetes (T1D) involves strict glucose control to avoid acute complications. The use of real-time continuous glucose monitors (rtCGM) relative to self-monitoring of blood glucose (SMBG) has demonstrated better glycemic control in T1D patients. This study aims to examine the distribution of patient demographics and frequency of clinical outcomes across the rtCGM and SMBG groups.

Methods

The analysis included 14,248 T1D patients in the T1D Exchange Quality Improvement (T1DX-QI) database for whom electronic medical record data was available from eight endocrinology clinics across the U.S. Patients over 2 years with at least one completed clinic encounter between July 2017 – February 2020 were included for analysis.

Results

In this population, 37% (N=5,276) of T1D patients were rtCGM users, whereas 63% (N=8,972) self-monitored blood glucose. Fewer Non-Hispanic Black (2% vs. 11%) and publicly insured patients (8% vs. 16%) used a rtCGM device relative to the SMBG group [p<0.001]. HbA1c levels were higher in the SMBG group compared to those using rtCGM (Mean [SD],%: 8.8 [2.1] vs. 8.1[1.7] [p<0.001]), and events of severe hypoglycemia (8% vs.10%) and diabetic ketoacidosis (2% vs. 7%) were less frequently recorded for rtCGM users relative to the SMBG group [p<0.001].

cgm_smbg_table.png

Conclusions

This study highlights inequities in adoption of rtCGM for glycemic control, while consolidating previous findings demonstrating rtCGM device use being critical in effective management of blood glucose levels.

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ORAL PRESENTATION SESSION

PERFORMANCE OF THE GUARDIAN™ SENSOR 3 CONTINUOUS GLUCOSE MONITORING SYSTEM WITH NO CALIBRATION

Abstract

Background and Aims

Continuous glucose monitoring (CGM) is becoming an important tool for glycemic management and is an integral part of automated insulin delivery (AID) systems. Medtronic developed a new sensor algorithm for use with the Guardian™ Sensor 3 (GS3) glucose sensor that requires no calibration, and the present study assessed its performance.

Methods

There were 160 subjects (aged 18-80 years, ~64% with T1D) who wore GS3 sensors in the arm and abdomen. Data were compared with Yellow Springs Instrument (YSI) values and processed using the Zeus algorithm and incorporating different calibration schemes. The primary endpoint was determination of overall sensor glucose (SG) values within 20% of YSI reference, or ±20 mg/dL when SG was <80 mg/dL (20%/20). Other endpoints included overall mean absolute relative difference (MARD) between system and reference values, ±15 mg/dL at SG <70 mg/dL, and Consensus Error Grid (CEG) analyses.

Results

For no calibrations and the arm location, 20%/20 and ±15 mg/dL agreement rates were 88.0% (N=20,612 paired data points) and 89.6% (N=2456 paired data points), respectively. For the abdomen, the rates were 88.0% (N=18,423) and 92.1% (N=1963), respectively. MARD was 10.64% for the arm and 10.78% for the abdomen. MARD for the <70 mg/dL SG range was 12.61% for the arm and 14.78% for the abdomen. The CEG analyses determined 99.9% of points within the A+B range for both the arm (N=20,590) and abdomen (N=18,409) locations.

Conclusions

These data on the performance of the no-calibration Guardian™ Sensor 3 system may support non-adjunctive insulin dosing in standalone CGM and AID systems.

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ORAL PRESENTATION SESSION

FACTORS ASSOCIATED WITH IMPROVEMENT IN DIABETES-RELATED DISTRESS IN PEOPLE LIVING WITH TYPE 1 DIABETES WITH FREESTYLE LIBRE -ASSOCIATION OF BRITISH CLINICAL DIABETOLOGISTS (ABCD) STUDY

Abstract

Background and Aims

We have recently shown that use of FSL is associated with improvement in diabetes-related distress (DDS) in people with T1D. The objective of this study was to identify factors associated with improvement in DDS following the use of FSL.

Methods

The study was performed using data from the ABCD nationwide FreeStyle Libre audit. We collected diabetes-related distress scores at baseline and follow up (two-item diabetes distress screening instrument, ‘feeling overwhelmed by the demands of living with diabetes’ and ‘feeling that I am often failing with my diabetes routine’DDS2). An average item score of ≥3 (moderate distress) discriminated high from low-distressed subgroups. We used an unsupervised gradient boosting machine learning model (GBM) to identify the relative influence (RI) of post-FSL use on two components of DDS. Since the two components were correlated, we only present the factors associated with the change in DDS1 following FSL use.

Results

The study included 4,588 people living with T1D who had baseline and post-FSL DDS score and consisted of 48.6% female, with baseline, and post FSL HbA1c of 67.6(±16.02)) and 62.9 (±14.02) mmol/l and a baseline and post FSL DDS of 2.8(±1.4) and 2.2(±1.9) respectively. In the GBM model, improvement in the GOLD score (RI=42.2), and HbA1c with FSL use (RI=19.4), post-FSL HbA1c (RI=13.8) and the greater number of FSL scans per day (RI=10.07) were associated post FSL reduction in DDS.

Conclusions

Improvement in hypoglycaemia awareness, glycaemic control and engagement with FSL is associated with improved DDS in people living with T1D.

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ORAL PRESENTATION SESSION

ACCURACY OF RT-CGM SYSTEMS DURING CONTINUOUS AND INTERVAL EXERCISE IN ADULTS WITH TYPE 1 DIABETES

Abstract

Background and Aims

Real-time glucose monitoring systems (rt-CGMs) play an important role in the treatment decisions of subjects with type 1 diabetes (T1D), but their accuracy may be lower during exercise. We assessed the accuracy of several recent rt-CGMs in T1D subjects during both moderate continuous (CON) and interval training (IT) exercise.

Methods

In 22 patients, already using a rt-CGM, a second different sensor was applied. Participants performed, in a random order, a 30’ CON session, and a 30’ IT session. Data recorded by rt-CGMs were compared with the corresponding blood glucose values, measured by a glucose analyzer. The accuracy of rt-CGMs was assessed by the Sensor Bias (SB), the Mean Absolute Relative Difference (MARD) and the Clarke error grid.

Results

A total of 2355 plasma-sensor glucose paired points were collected. Both average plasma and interstitial glucose did not significantly differ during CON and IT. However, plasma glucose change at the end of exercise was greater during CON than during IT. During CON, the sensors overestimated plasma glucose more than during IT, as shown by both SB and MARD. Classifying the clinical performance according to the Clarke error grid, no differences were found between the exercise sessions and >97% of values were in the A+B zone.

Conclusions

In conclusion, continuous exercise affects rt-CGMs accuracy to a greater extent than interval training,likely due to larger acute glycemic variations. However, this phenomenon does not compromise clinical reliability of recent CGMs. Larger studies, should investigate a broader spectrum of activities in terms of intensity and type of exercise.

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