Diabetes Technology & Therapeutics

AIMS: To compare glycemic control and maternal-fetal outcomes of women with type 1 diabetes (T1D) using hybrid closed loop (HCL) vs. multiple daily insulin injections (MDI) plus continuous glucose monitoring (CGM). METHODS: Multicenter prospective cohort study of pregnant women with T1D in Spain. We evaluated HbA1c and time spent within (TIR), below (TBR) and above (TAR) the pregnancy-specific glucose range 3.5-7.8 mmol/L. Adjusted models were performed for adverse pregnancy outcomes including baseline maternal characteristics and center...

AIMS/HYPOTHESIS: To compare glycemic metrics during pregnancy between women with type 1 diabetes (T1D) delivering large for gestational age (LGA) and appropriate for gestational age (AGA) infants, and to identify predictors of LGA infants. METHODS: A cohort study including 111 women with T1D using intermittently scanned continuous glucose monitoring from conception until delivery. Average sensor-derived metrics: mean glucose, time in range (TIRp), time above range, time below range in pregnancy, coefficient of variation (CV) throughout pregnancy and in pregnancy intervals 0-10, 11-21, 22-33 and 34-37 weeks were compared between women delivering LGA and AGA infants...

OBJECTIVES To study real-world effect of switching to Insulin Glargine 300 U/mL (Gla-300) on glucose metrics in people with type 1 diabetes (T1D). METHODS This retrospective secondary-use study compared 151 adults who switched to Gla-300 from first-generation long-acting insulins (Switchers) to 281 propensity-score matched controls (Non-switchers) who continued first-generation long-acting insulins. Primary endpoint was difference in time in range (TIR) evolution. A fictive "switching" date was assigned to Non-switchers to facilitate between-group comparisons...

OBJECTIVE: Examine gestational safety, glycemic and health outcomes of a hybrid closed-loop (HCL) system without pregnancy-specific glucose targets. RESEARCH DESIGN: This was a pilot feasibility investigator-initiated, two-site, single blind, randomized controlled trial of sensor-augmented pump therapy (SAPT) vs HCL therapy in type 1 diabetes pregnancies. Participants were enrolled in the first trimester, randomized at 14-18 weeks gestation, and used SAPT or HCL until 4-6 weeks post-partum...

Introduction Nocturnal hypoglycemia is generally calculated between 00:00 and 06:00. However, those hours may not accurately reflect sleeping patterns and it is unknown whether this leads to bias. We therefore compared hypoglycemia rates whilst asleep to those of clock-based nocturnal hypoglycemia in adults with type 1 (T1D) or insulin-treated type 2 diabetes (T2D). Methods Participants from the Hypo-METRICS study wore a blinded continuous glucose monitor and a Fitbit Charge 4 activity monitor for 10 weeks...

Treatment of type 1 diabetes mellitus (T1DM) has become increasingly technical with rapid developments in integration of pumps and sensors to regulate insulin dosage, and patient-initiated solutions as Open-Source Automated Insulin Delivery (OS-AID) systems, have gained popularity in people with diabetes. Studies have shown increased glycemic control and mental wellbeing in users of OS-AID systems. The aim of this study was to estimate the prevalence, the effect on metabolic control, the risk, and the effect on everyday life for users and their parents of OS-AID systems in Danish children and adolescents with T1DM...

No published data are available on the use of the community-derived open-source Loop hybrid closed-loop controller ("Loop") by individuals with type 2 diabetes (T2D). Via social media postings, we invited individuals with T2D currently using the Loop system to join an observational study. Thirteen responded of whom 7 were eligible for the study, were using the Loop algorithm, and provided data. Mean (±SD) age was 61±13 years and mean body mass index was 31±5 kg/m2. All but one participant were using noninsulin glucose-lowering medications...

BACKGROUND: Continuous glucose monitoring (CGM) improves neonatal outcomes in type 1 diabetes pregnancies, however its effectiveness has not been assessed in a real-world setting in the United States. OBJECTIVE: The Triple C Study aimed to examine clinical effectiveness, assessed through maternal glucose control and gestational health outcomes, of CGM use compared to self-monitoring of blood glucose (SMBG) in pregnancies associated with type 1 diabetes in a real-world setting...

Background: The Omnipod® 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical trials. Real-world evidence is needed to explore effectiveness in nonstudy conditions. Methods: A retrospective analysis of the United States Omnipod 5 System users (aged ≥2 years) with T1D and sufficient data (≥90 days of data; ≥75% of days with ≥220 continuous glucose monitor readings/day) available in Insulet Corporation's device and person-reported datasets as of July 2023 was performed...

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Introduction Most continuous subcutaneous insulin infusion (CSII) catheters (KT) are changed every 3 days. This study aims at evaluating whether KT changes impact glucose control while under open-loop (OL) or automated insulin delivery (AID) modes. Methods We included patients with type 1 diabetes (T1D) who used Tandem t:slim x2 insulin pump and Dexcom G6 glucose sensor for 20 days in OL, then as AID. CSII and sensor glucose data in OL and for the last 20 days of 3-month AID were retrospectively analyzed. The percentage of time spent with sensor glucose above 180 mg/dL (%TAR180) was compared between the calendar day of KT change (D0), the next day (D1) and two days later (D2)...

Introduction: Continuous glucose monitoring (CGM) has shown favorable outcomes in patients with type 2 diabetes (T2D) who are on insulin therapy. However, the efficacy of CGM in managing glucose levels in noninsulin-treated people with T2D remains controversial. Methods: PubMed, Cochrane, and Embase were searched for randomized controlled trials (RCTs) comparing CGM to self-monitoring of blood glucose (SMBG) in people with T2D not using insulin. We computed weighted mean differences (WMDs) and standard mean differences (SMD) for continuous outcomes, with 95% confidence intervals (CIs)...

OBJECTIVE: To assess the clinical impact on quality of life and on fear of hypoglycemia (FoH) of flash glucose monitoring (FGM) systems in adults with type 1 diabetes (T1DM). METHODS: Prospective quasi-experimental study with 12-month follow up. People with T1DM (18-80 years old) and self-monitoring by blood capillary glycemia controls (SMBG) were included. The FH15 questionnaire, a survey validated in Spanish in a comparable study population, was used to assess FoH...

Objective To evaluate postprandial glucose control when applying (i)faster-acting insulin aspart (Fiasp) compared to insulin aspart, and (ii)ultra-rapid insulin lispro (Lyumjev) compared to insulin lispro using the CamAPS FX hybrid closed-loop algorithm. Research Design and Methods We undertook a secondary analysis of postprandial glucose excursions from two double-blind, randomized, crossover hybrid closed-loop studies contrasting Fiasp to standard insulin aspart, and Lyumjev to standard insulin lispro (NCT04055480,NCT05257460)...

Background Time in range (TIR), time in tight range (TITR) and average glucose (AG) are used to adjust glycemic therapies in diabetes. However, TIR/TITR and AG can show a disconnect, which may create management difficulties. We aimed to understand the factors influencing the relationships between these glycemic markers. Materials and methods Real-world glucose data were collected from self-identified diabetes individuals using flash continuous glucose monitoring (CGM). The effects of glycemic variability (GV), assessed as glucose coefficient of variation (CV), on the relationship between AG and TIR/TITR was investigated together with the best-fit glucose distribution model that addresses these relationships...

Differences in the effectiveness of real-time continuous glucose monitoring (rtCGM) and intermittently scanned continuous glucose monitoring (isCGM) in type 1 diabetes (T1D) are reported. The impact on percentage time in range of switching from an isCGM with glucose threshold-based optional alerts only (FreeStyle Libre 2, FSL2) to rtCGM (Dexcom G7) with an urgent low soon predictive alert was assessed, alongside other secondary outcomes including HbA1c and other CGM metrics. Adults with T1D using FSL2 were switched to Dexcom G7 for 12 weeks...

We evaluated accuracy and safety of a seventh-generation real-time continuous glucose monitoring (CGM) system in pregnancy. Evaluable data for accuracy analysis were obtained from 96 G7 sensors (Dexcom, Inc.) worn by 96 of 105 enrolled pregnant women with type 1 (n=59), type 2 (n=21), or gestational diabetes (n=25). CGM values were compared with arterialized venous glucose values from the YSI comparator instrument during 6-hour clinic sessions at different time points throughout the sensors' 10-day wear period...

Older adults with type 1 diabetes may face challenges driving safely. Glucose "above 5 to drive" is often recommended for insulin-treated diabetes to minimize hypoglycemia while driving. However, the effectiveness of this recommendation among older adults has not been evaluated. Older drivers with type 1 diabetes were assessed while using sensor-augmented insulin pumps during a 2-week clinical trial run-in. Twenty-three drivers (median age 69 years [IQR 65-72]; diabetes duration 37 years [20-45]) undertook 618 trips (duration 10 min [5-21])...

Continuous glucose monitoring (CGM) has become the standard of care in diabetes management with the recent advances in technology and accessibility in the last decade. An International Consensus was established to define CGM metrics and its goals in diabetes care. The 2019 International Consensus suggested 14 days of CGM sampling for the assessment of CGM metrics stating the limitations that may occur for hypoglycemia and glycemic variability metrics. Since then, several studies assessed the correlation between CGM metrics and duration of the sampling period...

BACKGROUND: We used continuous glucose monitoring (CGM) data to investigate glycemic outcomes in a real-world population with type 1 diabetes (T1D) from South Korea, where the widespread use of CGM and the nationwide education program began almost simultaneously. METHODS: Data from Dexcom G6 users with T1D in South Korea were collected between January 2019 and January 2023. Users were included if they provided at least 90 days of glucose data and used CGM at least 70% of the days in the investigational period...