Background and Aims

Time in range (TIR; glucose of 70-180 mg/dL) overcomes some of the limitations of HbA1c in the individual assessment of glycemic control. This study evaluates whether TIR is associated with the presence of chronic complications in a real-world population of people with type 1 diabetes (T1D).

Methods

Sensor-measured TIR and the occurrence of microvascular (diabetic retinopathy [DR], diabetic nephropathy [DN], diabetic peripheral neuropathy [DPN]) and macrovascular complications in 812 people with T1D were analyzed cross-sectionally. Binary logistic regression was used to evaluate the contribution of TIR to the presence of chronic complications, after correction for sex, age, diabetes duration, BMI, blood pressure, lipid profile, smoking, lipid lowering and antihypertensive therapy.

Results

Mean TIR was 52.7 ± 15.2%. Overall, 46.1% had at least one microvascular complication (34.5% DR, 23.9% DN, 16% DPN) and 16.6% suffered from any macrovascular complication. The prevalence of at least one microvascular complication (p for trend <0.001), DR (p for trend <0.001) and DN (p for trend =0.036) decreased with increasing TIR quartiles (figure 1). The odds ratio of having at least one microvascular complication, DR, DN, DPN or any macrovascular complication per 1% increase in TIR was 0.969 (95%CI: 0.957-0.982, p<0.001), 0.959 (95%CI: 0.945-0.974, p<0.001), 0.981 (95%CI: 0.967-0.995, p=0.008), 0.980 (95%CI: 0.964-0.997, p=0.019) and 0.975 (95%CI: 0.958-0.992, p=0.005) respectively.

Conclusions

TIR is inversely associated with the presence of chronic diabetes complications. These data add validity to the use of TIR as key measure of glycemic control and endpoint of clinical trials, in addition to HbA1c.

Background and Aims

Impaired awareness of hypoglycaemia (IAH) causes significant morbidity and mortality in people living with diabetes. This analysis of audit data was performed to ascertain the prevalence of IAH before and after FreeStyle Libre (FSL) use, factors associated with IAH and improvement in awareness of hypoglycaemia following initiation of FSL.

Methods

Data of adults living with diabetes in the UK using FSL, collected from the ABCD audit were analysed. The Gold score was used to assess awareness of hypoglycaemia; a score of ≥4 indicated IAH, a score of 7 indicated complete unawareness of hypoglycaemia. Paired data was used to investigate prevalence and logistic regression analyses were performed to explore factors associated with IAH.

Results

There were 14248 adults living with diabetes (96.4% had Type 1 diabetes) and 6383 people had follow-up data, mean follow-up time 7.6 months. The baseline prevalence of IAH, complete unawareness of hypoglycaemia and severe hypoglycaemia (in previous 12 months) in this population was 28.1%, 3.7% and 14.4% respectively. With the use of FSL, the prevalence of IAH, complete unawareness of hypoglycaemia and severe hypoglycaemia reduced to 18.1%, 3.2% and 4.7% respectively. Improved awareness of hypoglycaemia with the use of FSL was associated with a shorter duration of diabetes(P=0.001) and a higher percentage time in range(P=0.004).

Conclusions

This national audit shows the significant prevalence of IAH in people living with diabetes. We identified that Freestyle Libre use is associated with a reduction of IAH, complete unawareness of hypoglycaemia and severe hypoglycaemia in people with Type 1 diabetes.

Background and Aims

Continuous glucose monitoring (CGM) is associated with significant improvements in hemoglobin A1c (HbA1c) in youth with type 1 diabetes (T1D). Youth from racial/ethnic minority groups and youth with public insurance use CGM less and have higher HbA1c. To expand CGM access, all youth with T1D were offered CGM within one month of diagnosis through the 4T Study.

Methods

We recruited 135 youth with new-onset diabetes to the 4T study (diagnosed 2018-2020) and compared HbA1c levels with a historical cohort (diagnosed 2014-2016) over a 12-month period by race/ethnicity and insurance status. Utilizing locally estimated scatter plot smoothing, descriptive differences in HbA1c by groups were evaluated.

Results

Hispanic youth and youth with public insurance in the 4T cohort had an improvement in HbA1c when compared to historical counterparts (Figures 1a & 1b). Within the 4T cohort, compared to youth with private insurance, youth with public insurance had a lower HbA1c at diagnosis but higher HbA1c by 12 months (Figure 1a). Similarly, compared to non-Hispanic white youth, Hispanic youth had lower HbA1c at diagnosis but higher HbA1c by 12 months post-diagnosis (Figure 1b).

Conclusions

While Hispanic youth and youth with public insurance experienced improvements in HbA1c with the 4T intervention, disparities in HbA1c outcomes by race/ethnicity and public insurance persisted within the 4T cohort. Thus, expanding CGM access in this cohort improved, but did not eliminate HbA1c disparities by race/ethnicity and insurance status. These data support expanding CGM access to all youth with T1D and underscore the need to address additional drivers of diabetes disparities.

Background and Aims

Some women living with diabetes report variability in glycemic control according to the phases of menstrual cycle. The purpose of this study was to evaluate this through continuous glucose monitoring data in type 1 diabetes.

Methods

We analyzed 62 spontaneous menstrual cycles in 24 women living with type 1 diabetes. We selected 5 phases of 3 days for each cycle: (1) early follicular (menstruations), (2) mid follicular, (3) peri-ovulatory, (4) mid luteal and (5) late luteal phase. The primary outcome was time in range (TIR). Interclass correlation coefficient (ICC) was used to assess the intra patient variability between menstrual cycles. A linear mixed model was used for statistical analyses.

Results

Mean (± standard deviation) age was 34.3±6.7 years, body mass index 26.6±4.5 kg/m², diabetes duration 17.5±10.9 years. ICC for TIR between different cycles in the 17 women with 3 consecutive cycles was 0.94 (95% confidence interval: 0.87-0.97). TIR decreased from early follicular phase to late luteal phase (61±18%; 59±18%; 59±20%; 57±18% and 55±20%, p=0.02). Linear mixed model showed a decrease in mid luteal (p=0.03) and late luteal phase (p<0.001) compared to early follicular phase. Time above range (TAR) was significantly higher during the late luteal phase than in early follicular phase.

Conclusions

In women living with type 1 diabetes, glucose rises[jr1] in a linear way across the menstrual cycle to reach its maximum in the late luteal phase with a brutal decrease at the very beginning of the menstrual bleeding in most women. This should be taken into consideration to avoid hypoglycemia.

Background and Aims

Continuous Glucose Monitoring (CGM) percent time-in-range (%TIR) and mean CGM glucose (AVG^CGM) are used clinically as metrics for short term glucose control and proxies for HbA1c levels. Correlations of %TIR, AVG^CGM and HbA1c values have been validated in adults with diabetes but there is limited associative data among these metrics in youth with diabetes. We provide data from an advanced, factory calibrated sensor to analyze the relationship between the three metrics in a pediatric population.

Methods

%TIR and AVG^CGM from Dexcom G6 sensors were collected and paired with clinically obtained HbA1c values from youth with type 1 diabetes (age 3-23 years) at scheduled points (Baseline, 3-, 6-, 9- and 12-month) in the first year of Tandem Control IQ use. Pairwise linear regressions between all three metrics were performed.

Results

Data were collected from 183 youth (mean age 13.1 years, 52% male). Average HbA1c was 7.61% (5.3-12.6%). Agreement was strongest between AVG^CGM and %TIR (R² = 0.9; Figure D), followed by AVG^CGM and HbA1c (R²=0.65; Figure B). %TIR by HbA1c (R²=0.63; Figure C) indicate that a 10% change in TIR was correlated with a 0.52% change in HbA1c. A TIR of 76.9% correlated with an HbA1c of 7%.

Conclusions

This is the first study examining the relationship between %TIR and HbA1c with pediatric data only, and importantly, indicates a higher %TIR may be necessary to achieve the HbA1c target in youth than in adults. Further studies should confirm and explore the clinical implications of these data.

Background and Aims

The UK has seen increasing access to continuous glucose monitoring, particularly isCGM (FSL), with more than half of those with type 1 diabetes in England now using this technology. It is therefore essential to understand the effect of the FSL on glycaemic control and resource consumption in people living with diabetes

Methods

Clinicians from 106 NHS UK hospitals submitted FSL user data (16,034 participants living with diabetes (96% type 1 diabetes) of whom 6859 had follow-up), collected during routine clinical care to a web-based tool held within the NHS N3 network.

Results

Use of FSL was associated with a 67% reduction in hospital admissions due to hypoglycaemia, a 63% reduction in hospital admissions related to hyperglycaemia and/or DKA and an 85% reduction in paramedic callouts. At follow-up, 3250 (47%) had TIR reported. Of these, 1241 (38%) used the international consensus time in the range of 3.9–10 mmol/l (icTIR). HbA1c reduction was greater in those with a higher proportion of TIR with a reduction of 6.8 mmol/mol for TIR≥ 50% and 9.8 mmol/mol for those with TIR≥ 70%. None of the participants with TIR of ≥50% had hypoglycaemia related to hospital admissions during the follow-up period. The reduction in hospital admissions for hyperglycaemia/DKA and paramedic callouts was independent of the TIR achieved during follow-up.

Conclusions

In a large cohort of UK FSL users, we demonstrate a significant reduction in HbA1cand resource consumption which in the case of HbAic and hypoglycaemic events was associated with improved TIR

Background and Aims

Continuous glucose monitoring (CGM) use in type 2 diabetes (T2D) is expanding despite limited data about real-world use. HealthPartners is a large integrated healthcare system containing clinical and insurance claims data for member-patients. This analysis describes clinical characteristics of member-patients prescribed CGM.

Methods

A retrospective, observational chart and claims review was conducted for T2D patients prescribed CGM, who receive care and insurance through HealthPartners. Aims: 1) describe pre-CGM to post-CGM changes in HbA1c; 2) describe medication patterns pre-CGM to post-CGM; 3) quantify associations of change in HbA1c with CGM usage and demographics.

Results

From January 1, 2018 to December 31, 2020, CGM was prescribed to 2231 T2D patients (9.4% of total T2D population). 93.2% of prescriptions were filled (84% filled within 30 days). Pre-CGM HbA1c (closest HbA1c 0-6 months prior) was 8.9%+/-2.1%, versus post-CGM (closest HbA1c 8 weeks-12 months after CGM) 8.0%+/-1.7% (p=<0.0001). Pre-CGM, HbA1c <8.0% in 35.6% of patients, versus 52.8% post-CGM. GLP-1 agonist use increased regardless of baseline HbA1c; analog insulin use increased if pre-CGM HbA1c was >10%. Sulfonylurea use decreased if HbA1c <10%. Male sex, age, and filling CGM <30 days demonstrated significant HbA1c decrease; BMI, race, and number of medications did not correlate with HbA1c.

Conclusions

In a large cohort of patients with T2D, HbA1c decreased after filling CGM. Medication patterns also changed, suggesting CGM influenced therapeutic adjustments and possibly contributed to reducing HbA1c. Those who filled their CGM sooner saw the largest decrease in HbA1c, suggesting early patient engagement may be important for successful CGM use in T2D.

Background and Aims

Background: There are limited data on CGM patterns among people with diabetes treated by chronic hemodialysis, particularly using newer Dexcom G6 systems.

Methods

Methods: Prospective observational study of people (> 18 years), with insulin-treated, type 2 diabetes, receiving chronic hemodialysis at Emory’s kidney centers. Patients wore a Dexcom G6 Pro for 10 days. Outcomes of interest included mean CGM glucose, time-in-range (TIR), above (TAR) and below (TBR) range, and rates of overall hypoglycemia (lasting for at least 15 min), nocturnal (from 22-06hrs) and prolonged (lasting for at least 120 min).

Results

Results: Among 34 patients (mean age 57.5±10, 55% females), mean daily CGM glucose was 189± 47 mg/dl, TIR 52±26.7%, TAR > 180 mg/dl 47±28%, TAR > 250 mg/dl 30±22%, TBR 1.2±2.4%, and HbA1c 7.1±1.5%.

Hypoglycemic episodes < 70 and < 54 mg/dl occurred in 56% and 26% of patients, respectively; with nocturnal hypoglycemia occurring in 29% and 8.8% of subjects, respectively. Prolonged hypoglycemia < 70 mg/dl and < 54 mg/dl occurred in 8.8% of subjects. During 10 days, subjects with hypoglycemia < 70 mg/dl, had a mean of 3.7±4 episodes overall, 3.2±4.3 nocturnal episodes, and 2.6±1.8 episodes of < 54 mg/dl. Up to 71% of patients had >5% CGM time in > 250 mg/dl.

Conclusions

Conclusion: People with diabetes on chronic hemodialysis are exposed to large glycemic excursions, with tendency to persistent hyperglycemia, and less frequent -yet common- hypoglycemic episodes. There is a critical need for future interventional studies assessing better glycemic efficacy and safety in this population.

Background and Aims

Guidelines suggest a stepped-care approach in the management of patients with IAH, initially with structured psycho-educational programs based on BGAT, progressing to diabetes technology in those with persisting need. We examined the clinical effectiveness of a stepped-care approach starting with HypoAware (adaptation of BGAT) and adding continuous glucose monitoring (CGM) as needed, versus immediate CGM in type 1 diabetes patients with IAH.

Methods

A pragmatic prospective, parallel-group, multicenter, controlled trial. The intervention group attended HypoAware. If IAH was still present after 6 months or a severe hypoglycemic event (SHE) had occurred, CGM was offered. Primary endpoint was the number of participants with self-reported SHE. Secondary outcomes, evaluated at 6 and 12 months, were HbA1c, the number of participants with IAH, time in clinically significant hypoglycemia (<3.0 mmol/L;TCSH).

Results

At 6 months, the primary endpoint had decreased significantly more in the CGM group compared to the stepped-care group:-63% vs -27% (p<0.05). HbA1c decreased more in CGM group (-0.41 percentage points [-0.49 to -0.25], P<0.05). The number of patients without IAH increased in both groups (+33% vs +32%). TCSH was lower in the CGM group (p<0.05). In the stepped-care group n=17 started CGM, n=11 started isCGM, and n=2 patients started neither CGM nor isCGM. At 12 months the number of patients reporting SHE was still higher in the stepped-care group compared to the CGM group (p<0.05).

Conclusions

In individuals with type 1 diabetes with IAH and a high risk of SHE immediate start of CGM is more effective in reducing SHE risk.