Displaying One Session

ORAL PRESENTATION SESSION
Session Type
ORAL PRESENTATION SESSION
Channel
La Paz
Date
22.02.2020, Saturday
Session Time
08:30 - 10:00

REBOUND HYPERGLYCEMIA AND THE EFFECTS OF CONTINUOUS GLUCOSE MONITORING IN THE HYPODE CLINICAL STUDY

Abstract

Background and Aims

Symptomatic hypoglycemia can motivate carbohydrate intake and deprioritize accurate carbohydrate counting, which may contribute to rebound hyperglycemia (RH) and worsen glycemic control. We examined the effects of real-time continuous glucose monitoring (CGM) on RH.

Methods

The HypoDE study (NCT02671968) randomized 149 adults with T1D and problematic hypoglycemia to an intervention group including rtCGM (n=75) or a control group without rtCGM. During pre-randomization, blinded data were collected for 4 weeks with Dexcom G4 (software 505) systems. The intervention group used unmasked rtCGM (Dexcom G5 Mobile) for a 22-week therapy phase and a 4-week follow-up phase. An RH event was defined as any estimated glucose value (EGV) >180 mg/dL occurring within 2 hours of an EGV <70 mg/dL. The severity of RH events was calculated as the area under the curve (AUC) for consecutive EGVs >180 mg/dL. RH duration was time with consecutive EGVs >180 mg/dL starting within 2 hours of an EGV <70 mg/dL. RH events were evaluated and compared for each user in the intervention group during blinded and follow-up phases with t-tests.

Results

The Table shows mean (SD) frequency, severity, and duration of RH events. All were attenuated during the unblinded phase of the study.

Blinded Unblinded Difference, % p-value
Events per week, n 2.39 (1.62) 2.06 (1.49) 14 0.027
AUC >180, mg/dL×min 54034 (59790) 45732 (48601) 15 0.009
Duration, min 215 (217) 188 (186) 12 0.022

Conclusions

In the HypoDE study, access to rtCGM data was associated with favorable reductions in the frequency, severity, and duration of rebound hyperglycemic events.

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ACCURACY OF THE DEXCOM G6 SYSTEM DURING AEROBIC, RESISTANCE, AND INTERVAL EXERCISE IN ADULTS WITH TYPE 1 DIABETES

Abstract

Background and Aims

Accuracy of continuous glucose monitoring (CGM) systems may be impacted by exercise. We evaluated the impact of three different types of exercise on the Dexcom G6 system.

Methods

Twenty-four adults with type 1 diabetes on multiple daily injections wore two Dexcom G6 systems. Participants were randomized to aerobic, resistance, or high intensity interval exercise. Each participant completed 2 in-clinic sessions. The CGM systems were inserted a mean 5.3 days prior. Capillary blood glucose measurements were performed with a Contour Next meter. No CGM calibrations were performed.

Results

The mean absolute relative difference (MARD) of the G6 CGM system as compared to the Contour Next CBG measurements did not differ statistically using a paired Wilcoxon rank test from baseline across all exercise types (see table with mean±SD). The mean relative difference (MRD) was significantly different than baseline only for aerobic exercise at 45 min and for resistance at 30 min (P<0.05).

Conclusions

The accuracy of the no-calibration Dexcom G6 CGM system was not impacted by aerobic, anaerobic, or high intensity interval exercise.

Start

10 min

20 min

30 min

45 min

60 min

Aerobic

MARD (%)

11.6±10.4

13.9±12.7

12.2±10.8

15.9±12.9

13.4±8.9

13.3±7.8

MRD (%)

-0.2±15.9

2.6±19.0

3.2±16.3

3.6±20.5

-6.4±15.0*

-4.8±15.0

Resistance

MARD (%)

11.2±9.5

11.2±8.4

11.8±8.4

13.1±12.8

10.4±5.5

11.8±8.3

MRD (%)

-7.8±12.6

-5.3±13.2

-4.0±14.3

1.1±18.6*

-5.2±10.8

-7.1±12.8

Start

10 min

20 min

35 min

50 min

High Intensity Intervals

MARD

13.9±9.8

12.0±6.7

12.3±6.5

13.5±10.2

11.1±7.1

MRD (%)

-10.3±13.8

-9.2±10.4

-10.8±8.9

-12.6±11.4

-7.7±10.9

*P<0.05 as compared to the start of exercise.

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A STUDY TO ASSESS INITIATION OF CGM OUTSIDE OF A CLINIC

Abstract

Background and Aims

Our study assessed the feasibility of remotely initiating continuous glucose monitoring (CGM) at home outside of the clinic, as a means to expand CGM access.

Methods

35 adults 19-80 years old (mean HbA1c 8.5%) with T1D (N=28) or T2D (N=7) using basal-bolus insulin (7 pump, 28 MDI) with no CGM use within 24 months of enrollment were assigned a certified diabetes educator to provide remote CGM training via videoconference and/or phone. Participants selected either the Dexcom G6 or Abbott FreeStyle Libre and were followed for 12 weeks to assess adherence to CGM use and glycemic control.

Results

One participant withdrew immediately after CGM initiation training. The remaining 34 were using CGM at 12 weeks; median CGM usage in the final 4 weeks was 7.0 days/week (interquartile range 6.7 to 7.0). One additional participant did not have an HbA1c at 12 weeks. Mean HbA1c reduction from baseline to 12 weeks was 1.1% (P<0.001). Mean time in range (70-180 mg/dL) was 59% over the 12 weeks compared with baseline time in range estimated from HbA1c of 48%. Over 12 weeks, median time <70 mg/dL was 1.4% and <54 mg/dL was 0.2%. Surveys indicated substantial benefit of CGM with reduced diabetes distress, increased satisfaction with glucose monitoring and fewer perceived technology barriers to management.

Conclusions

Remote CGM initiation and training was successful in achieving sustained CGM use and improved glycemic control after 12 weeks. If widely implemented, this approach could substantially increase the adoption of CGM by people with diabetes using insulin.

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CONTINUOUS GLUCOSE MONITORING METRICS IN DCCT/EDIC STUDY PARTICIPANTS WITH TYPE 1 DIABETES OF OVER 35 YEARS DURATION

Abstract

Background and Aims

To characterize continuous glucose monitoring (CGM) metrics among participants enrolled in the DCCT/EDIC study and correlate them with concurrent HbA1c.

Methods

765 DCCT/EDIC participants wore a blinded CGM (Libre Pro, Abbott) for a minimum of 6.5 days (average 11.9±1.9 days). CGM metrics were calculated separately for daytime and nighttime and correlated with concurrent central laboratory HbA1c. Management regimens included pump (58%) and personal CGM (27%). Participants utilizing insulin suspend pumps (n=85) were not included in the primary analysis.

Results

Participants were 58.9±6.5 years old, 53% male, duration 36.8±4.9 years, and HbA1c 7.8±1.2%. Daytime mean glucose was 173.1±38.6 mg/dL, CV (42.6±7.5%), Time in Range-TIR70-180 (51.4±14.8%), T<70 (8.2±7.3%), T<54 (3.5±4.6%) and T>180 (40.4±18.1%). Compared to daytime, nighttime mean glucose was lower (159.3±43.1 mg/dL) and there was more nocturnal hypoglycemia (T<70 13.1±12.9%; T<54 7.2±9.3%); while nocturnal CV (43.0±11.3%) and TIR70-180 (51.7±17.5%) were similar to daytime. Correlations of mean glucose and TIR70-180 with HbA1c were 0.66 and -0.61, respectively. On average, a TIR70-180 of 50% and 70% corresponded to an HbA1c of 7.9% and 6.9%, respectively. Few participants achieved the 2019 TIR Consensus Targets: 9.0% achieved >70% TIR70-180; 29.8% achieved <4% T<70; and 28.0% achieved <1% T<54. Participants using insulin suspend pumps (n=85) had less hypoglycemia (T<54) than the main cohort (n=765) both during daytime (2.7±4.2% vs. 3.5±4.6%, p=0.0197) and nighttime (4.5±6.3% vs. 7.2±9.3%, p=0.0013), respectively.

Conclusions

These CGM metrics from the DCCT/EDIC cohort suggest that strategies to lower meal-stimulated hyperglycemia during the day and hypoglycemia at night in older type 1 diabetes patients are still needed.

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REMOTE APPLICATION AND USE OF CONTINUOUS GLUCOSE MONITORING BY ADULTS WITH TYPE 2 DIABETES IN A VIRTUAL DIABETES CLINIC

Abstract

Background and Aims

The Onduo Virtual Diabetes Clinic (VDC) is a telemedicine program for people with T2D that combines mobile app technology, remote lifestyle coaching, connected BG meters and CGM devices, and clinical support from board-certified endocrinologists. This analysis assessed participant satisfaction and change in HbA1c with real-time (rt)CGM use.

Methods

Adults with T2D (n=762) who were clinically evaluated, prescribed and mailed rtCGM devices, and used >/=1 sensor from March 2018-July 2019 were sent a CGM satisfaction questionnaire (5-point scale: 1=strongly disagree; 5=strongly agree). Change in HbA1c was assessed in a subset of participants with HbA1c measurements pre- and post-rtCGM use.

Results

Respondents (n=595; 78%) were: 53.0+/-8.4 years, 62.4% female and 60.8% were not previously familiar with CGM. The overall CGM satisfaction score was 4.5+/-0.8. The majority of respondents (94.8%) agreed/strongly agreed that they were comfortable inserting the sensor remotely with guidance from their coach and that rtCGM use: improved understanding of the impact of eating (97.0%); increased diabetes knowledge (95.6%); and helped improve diabetes control when not wearing the sensor (79.5%). Most respondents (70.5%) disagreed/strongly disagreed that rtCGM provided too much information. HbA1c (n=372) decreased significantly from 7.7%+/-1.6 to 7.1%+/-1.2 overall and by 2.6%+/-2.0, 0.9%+/-1.4 and 0.4%+/-0.8, for participants with baseline HbA1c levels of >9.0%, 8.0%-9.0%, and 7.0%-<8.0%, respectively (all p<0.001; mean follow-up 10.2 months).

Conclusions

These results suggest that it is feasible to provide rtCGM directly to individuals with T2D through a VDC without in-office training. Intermittent use of rtCGM was well-received by adults with T2D and was associated with improvement in HbA1c.

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'HIGH ACCURATE BGMS BASED ON INNOVATIVE OPTICAL TRANSMISSION ABSORBANCE SYSTEM TO REALIZE ACCURACY WITHIN ±5%

Session Type
ORAL PRESENTATION SESSION
Date
22.02.2020, Saturday
Session Time
08:30 - 10:00
Channel
La Paz
Lecture Time
09:20 - 09:30

Abstract

Background and Aims

Since the blood glucose monitoring system (BGMS) is essential in diabetes care and management, reasonable price of test strip and further improvement of the accuracy of BGMS is mandatory to achieve the better glycemic control of diabetics. In the past ATTD, we proposed the principle of BGMS based on innovative optical transmission absorbance system with ecological and economical electrodeless optical type test strip. In this study, we report the clinical evaluation results of newly developed compact BGMS.

Methods

To realize the highly accurate and convenient BGMS, we have developed highly sensitive reagent, with brand new enzyme and original absorption dye for test strip, and accurate glucose and hematocrit measurement algorithm, with small multi-LED module for compact meter. To realize the ecological and economical test strip, we have developed an optical type test strip without expensive electrode layer, which can enable to decrease the strip cost compared to conventional electrochemical test strips. The accuracy of our new BGMS was evaluated according to the guideline of ISO 15197:2013 by clinical evaluation.

Results

New BGMS was evaluated with venous blood collected from 104 diabetic patients. Our new BGMS achieved accuracy more than 95% of data within ± 7.1% and met the ISO 15197:2013 requirement.

Conclusions

We have developed a novel BGMS with innovative optical transmission absorbance system. Our new BGMS achieved accuracy more than 95% of data within ± 7.1% and met the ISO 15197:2013 requirement. In the next step, we will achieve accuracy within ± 5% through development including algorithm improvement.

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IMPACT OF HIGH-INTENSITY INTERVAL TRAINING ON NIGHTTIME GLUCOSE VALUES BY USING INTERMITTENT CGM IN PEOPLE WITH TYPE 1 DIABETES: A PILOT STUDY

Session Type
ORAL PRESENTATION SESSION
Date
22.02.2020, Saturday
Session Time
08:30 - 10:00
Channel
La Paz
Lecture Time
09:30 - 09:40

Abstract

Background and Aims

The impact of different types of exercise on glucose homeostasis in people with type 1 diabetes still remains to be quantified. High Intensity Interval Training (HIIT) is often recommended as an effective and safe physical exercise for people with diabetes. The aim of this analysis was to evaluate the impact of HIIT on the nighttime glucose profiles in people with type 1 diabetes.

Methods

Six males (36.7±6.1 years-old; BMI 25.1±1.8 kg/m2) performed three HIIT weekly sessions using elastic bands for 12 weeks, with 48h rest in-between. Continuous glucose were recorded using a FreeStyle Libre® (FSL, Abbott, CA, USA) two-weeks before study initiation (baseline), on the first two-weeks of HIIT (First period), and on the last two-weeks (Last period). Glucose control was evaluated for <54 mg/dL, 54–70 mg/dL, 70–180 mg/dL, 80–140 mg/dL, 180–250 mg/dL and >250 mg/dL ranges, plus the mean glucose value overnight and the coefficient of variability (CV). The evaluated nighttime period was considered from midnight to 07:00 AM after each exercise session.

Results

No significant reduction was observed in time-in-range (in both ranges 70–180 or 80–140 mg/dL) between baseline, first and last periods. Similarly, time-in-hypoglycemia (<54 mg/dL and 54-70 mg/dL) showed also no significant changes after HIIT.

night.jpg

Conclusions

Our HIIT exercise program was proven to be safe for people with type 1 diabetes. No significance differences were observed in the time-in-range and other glycemic metrics, probably to small number of patients evaluated.

Funding: Spanish Gov. DPI2016-78831-C2-1-R, FEDER funds, UPV PAID-06-18

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MULTI-NATIONAL CLINICAL PERFORMANCE OF THE WAVEFORM CASCAD CGM SYSTEM

Abstract

Background and Aims

WaveForm has received CE Mark approval for the Cascade CGM, a trocar-less CGM system for people with diabetes. Part of the process leading to commercialization was a confirmation of the safety and efficacy of the system. The confirmation assessment included a multi-national 14-day in-clinic and home-use study.

Methods

The multi-national study was performed in clinical centers in Slovenia, Croatia and Serbia (n=57 diabetic subjects). Each subject inserted two 14-day CGM monitors. Subjects participated in home-use and in-clinic days. The five in-clinic days (day 1, 4, 7, 10 and 14), included 12 hours of blood glucose testing using a reference glucose analyzer. An accuracy assessment was completed comparing CGM glucose values to YSI values during in-clinic days and to fingerstick BGM glucose values during home use days.

Results

A total of 17669 in-clinic CGM/YSI data points were analyzed. %MARD was 11.4% and MAD was 14.7 mg/dL. Consensus-error grid analysis showed 99.3% of data points in zone A and B, and 0.7% in zone C. The system accuracy during home use was 12.7% and 15 mg/dL for %MARD and MAD, respectively. 98.6% of BGM/CGM readings were in zone A and B and 1.5% in zone C.

Conclusions

The performance of the Cascade / GlucoMen Day CGM device over 14 days meets the requirements of a non-adjunctive CGM system for managing blood glucose levels in people with diabetes. We expect to launch the Cascade CGM system in Europe under the brand name of GlucoMen Day (distributed by A. Menarini Diagnostics) in the fourth quarter of 2019.

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TIME IN RANGE TARGETS IN PREGNANT WOMEN WITH TYPE 1 DIABETES: ACHIEVEMENT AND ASSOCIATION WITH PREGNANCY OUTCOMES. AN ANCILLARY STUDY OF THE CONCEPTT TRIAL

Session Type
ORAL PRESENTATION SESSION
Date
22.02.2020, Saturday
Session Time
08:30 - 10:00
Channel
La Paz
Lecture Time
09:50 - 10:00

Abstract

Background and Aims

The International Consensus on Time in Range (TIR) recommendations for the interpretation of CGM data in people with diabetes have been recently published, and pregnant women with Type 1 diabetes are one of the groups considered. Proposed cut-offs and targets are listed below. Aims: 1) to address the rate of CGM-based clinical target achievement in pregnant women participating in CONCEPTt, 2) to evaluate associations between CGM target achievement and pregnancy outcomes.

Methods

241 women had 6-day CGM in 1sttrimester, 203 at 24-25 and 177 at 34-35 weeks. Outcomes: 1) % of women achieving the proposed targets in TIR, time below range (TBR) and time above range (TAR) at the three time points, 2) associations of target achievement with pregnancy outcomes. Statistics: Descriptive, chisquare, unadjusted logistic regression; significance p<0.05.

Results

1) The % women achieving the targets is displayed in the table, 2) Achieving the target for TAR at 24 and 34 weeks was associated with a reduced risk of LGA (OR 0.389, p 0.019 and OR 0.393, p 0.004 at 24 and 34 weeks respectively) and at 34 weeks with a reduced risk of preterm birth (OR 0.433, p 0.023). Achieving the target for TBR was associated with increased risks attributable to the subgroup of women only meeting this target (86.8% baseline, 93.5% at 24-25 weeks, 62.1% at 34-25 weeks)

table_t1dm pregnancy cgm targets.jpg

Conclusions

CONCEPTt trial participants in both arms increased CGM target achievement during pregnancy, differences between groups being apparent in the 3rdtrimester. Achieving the CGM target for TAR was associated with improved neonatal outcomes.

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