Hybrid Closed-Loop Therapy in Adults With Type 1 Diabetes and Above-Target HbA1c: A Real-world Observational Study.

OBJECTIVE: We explored longitudinal changes associated with switching to hybrid closed-loop (HCL) insulin delivery systems in adults with type 1 diabetes and elevated HbA1c levels despite the use of intermittently scanned continuous glucose monitoring (isCGM) and insulin pump therapy. RESEARCH DESIGN AND METHODS: We undertook a pragmatic, preplanned observational study of participants included in the National Health Service England closed-loop pilot. Adults using isCGM and insulin pump across 31 diabetes centers in England with an HbA1c ≥8.5% who were willing to commence HCL therapy were included. Outcomes included change in HbA1c, sensor glucometrics, diabetes distress score, Gold score (hypoglycemia awareness), acute event rates, and user opinion of HCL. RESULTS: In total, 570 HCL users were included (median age 40 [IQR 29-50] years, 67% female, and 85% White). Mean baseline HbA1c was 9.4 ± 0.9% (78.9 ± 9.1 mmol/mol) with a median follow-up of 5.1 (IQR 3.9-6.6) months. Of 520 users continuing HCL at follow-up, mean adjusted HbA1c reduced by 1.7% (95% CI 1.5, 1.8; P < 0.0001) (18.1 mmol/mol [95% CI 16.6, 19.6]; P < 0.0001). Time in range (70-180 mg/dL) increased from 34.2 to 61.9% (P < 0.001). Individuals with HbA1c of ≤58 mmol/mol rose from 0 to 39.4% (P < 0.0001), and those achieving ≥70% glucose time in range and <4% time below range increased from 0.8 to 28.2% (P < 0.0001). Almost all participants rated HCL therapy as having a positive impact on quality of life (94.7% [540 of 570]). CONCLUSIONS: Use of HCL is associated with improvements in HbA1c, time in range, hypoglycemia, and diabetes-related distress and quality of life in people with type 1 diabetes in the real world.

Real-World Outcomes of Glucose Sensor Use in Type 1 Diabetes-Findings from a Large UK Centre.

Flash glucose monitoring (FGM) and real-time continuous glucose monitoring (RT-CGM) are increasingly used in clinical practice, with improvements in HbA1c and time in range (TIR) reported in clinical studies. We aimed to evaluate the impact of FGM and RT-CGM use on glycaemic outcomes in adults with type 1 diabetes (T1DM) under routine clinical care. We performed a retrospective data analysis from electronic outpatient records and proprietary web-based glucose monitoring platforms. We measured HbA1c (pre-sensor vs. on-sensor data) and sensor-based outcomes from the previous three months as per the international consensus on RT-CGM reporting guidelines. Amongst the 789 adults with T1DM, HbA1c level decreased from 61.0 (54.0, 71.0) mmol/mol to 57 (49, 65.8) mmol/mol in 561 people using FGM, and from 60.0 (50.0, 70.0) mmol/mol to 58.8 (50.3, 66.8) mmol/mol in 198 using RT-CGM (p < 0.001 for both). We found that 23% of FGM users and 32% of RT-CGM users achieved a time-in-range (TIR) (3.9 to 10 mmol/L) of >70%. For time-below-range (TBR) < 4 mmol/L, 70% of RT-CGM users and 58% of FGM users met international recommendations of <4%. Our data add to the growing body of evidence supporting the use of FGM and RT-CGM in T1DM.

Continuous Subcutaneous Insulin Infusion Initiation Is Associated With Blood Pressure Reduction in Adults With Type 1 Diabetes.

BACKGROUND: In type 1 diabetes (T1D) continuous subcutaneous insulin infusion (CSII) use has been associated with lower risks for mortality and diabetes-related complications when compared to multiple daily injections. There are limited data on the effect of CSII on blood pressure (BP). We aimed to evaluate the relationship between CSII initiation and BP changes. METHODS: We performed a retrospective, single-center, observational study including all adults with T1D who initiated CSII between 2001 and 2014. Mean systolic BP levels were calculated from values obtained up to 15 months before and up 15 months after CSII initiation. RESULTS: We studied 436 adults (46% male; mean [95% CI] age: 45 [36, 54] years, duration of diabetes: 20.3 [19.1, 21.5] years). CSII was associated with the following changes (post minus pre CSII levels) in mean (95% CI) SBP and DBP levels, respectively: whole cohort (N = 436): -2 (-1, -3), P < .001 and -2 (-1, -2), P < .001; those taking stable antihypertensive medication (n = 118): -4 (-6, -2), P < .001 and -2 (-3, -1), P < .001; antihypertensive treatment-naïve patients (n = 279): -1 (-2, 0), P = .147 and -1 (-2, 0), P = .002. In multivariate regression analysis including age, sex, diabetes duration, pre-CSII BP, HbA1c and weight changes, only pre-CSII BP showed an independent association with BP drop in all patients' groups. Once adjusted for pre-CSII BP there was no significant difference between those on antihypertensive drugs and antihypertensive treatment-naïve individuals. CONCLUSIONS: We showed BP reduction in association with CSII therapy particularly in those on antihypertensive medication. These original findings may partly explain the cardiovascular and mortality benefits associated with CSII therapy.