Association of scan frequency with CGM-derived metrics and influential factors in adults with type 1 diabetes mellitus.

Introduction: This study aimed to investigate the association between scan frequency and intermittently scanned continuous glucose monitoring (isCGM) metrics and to clarify the factors affecting scan frequency in adults with type 1 diabetes mellitus (T1D). Methods: We enrolled adults with T1D who used FreeStyle® Libre. Scan and self-monitoring of blood glucose (SMBG) frequency and CGM metrics from the past 90-day glucose data were collected. The receiver operating characteristic curve was plotted to obtain the optimal cutoff values of scan frequency for the target values of time in range (TIR), time above range (TAR), and time below range (TBR). Results: The study was conducted on 211 adults with T1D (mean age, 50.9 ± 15.2 years; male, 40.8%; diabetes duration, 16.4 ± 11.9 years; duration of CGM use, 2.1 ± 1.0 years; and mean HbA1c, 7.6 ± 0.9%). The average scan frequency was 10.5 ± 3.3 scan/day. Scan frequency was positively correlated with TIR and negatively correlated with TAR, although it was not significantly correlated with TBR. Scan frequency was positively correlated with the hypoglycemia fear survey-behavior score, while it was negatively correlated with some glycemic variability metrics. Adult patients with T1D and good exercise habits had a higher scan frequency than those without exercise habits. The AUC for > 70% of the TIR was 0.653, with an optimal cutoff of 11 scan/day. Conclusions: In real-world conditions, frequent scans were linked to improved CGM metrics, including increased TIR, reduced TAR, and some glycemic variability metrics. Exercise habits and hypoglycemia fear-related behavior might affect scan frequency. Our findings could help healthcare professionals use isCGM to support adults with T1D.Clinical Trial Registry No. UMIN000039376.

Recovery of hypoglycemic confidence using intermittently scanned continuous glucose monitoring among adults with type 1 diabetes with level 3 hypoglycemia: A prospective, single-center, single-arm study.

AIM: To investigate whether the FreeStyle Libre, an intermittent scanning continuous glucose monitoring (isCGM) system, influences confidence in managing hypoglycemia in adults with type 1 diabetes. MATERIALS AND METHODS: This longitudinal, observational study conducted at one facility included 121 adults with type 1 diabetes. Participants used the conventional finger-prick method for self-testing glucose before using isCGM. At baseline and 12 months after initiating isCGM, the Hypoglycemic Confidence Scale (HCS), Diabetes Treatment Satisfaction Questionnaire (DTSQ), and HbA1c were performed. At 12 months, the percentage of individuals utilizing isCGM trend arrows for glucose management was observed. The primary endpoint was hypoglycemic confidence change attributed to using isCGM. RESULTS: After using isCGM, HCS scores improved significantly from 2.89 (2.56, 3.22) to 3.00 (2.20, 3.33) (p < 0.001); median (25%, 75%). Among participants with level 3 hypoglycemia at baseline, hypoglycemic confidence during sleep (p < 0.05), in social situations (p < 0.05), and in avoiding serious hypoglycemia-related problems (p < 0.05) were improved. Despite hypoglycemia risk, participants could continue daily activities by using isCGM (p < 0.05), and sixty-nine percent utilized trend arrows effectively. CONCLUSION: Using isCGM improved hypoglycemic confidence among adults with type 1 diabetes. Data analysis indicated that people with type 1 diabetes could live more freely and better manage hypoglycemia using isCGM.

Factors associated with hemoglobin glycation index in adults with type 1 diabetes mellitus: The FGM-Japan study.

AIMS/INTRODUCTION: The discrepancy between HbA1c and glucose exposure may have significant clinical implications; however, the association between the hemoglobin glycation index (HGI) and clinical parameters in type 1 diabetes remains controversial. This study aimed to find the factors associated with HGI (laboratory HbA1c - predicted HbA1c derived from the continuous glucose monitoring [CGM]). MATERIALS AND METHODS: We conducted a cross-sectional study of adults with type 1 diabetes (n = 211, age 50.9 ± 15.2 years old, female sex = 59.2%, duration of CGM use = 2.1 ± 1.0 years). All subjects wore the CGM for 90 days before HbA1c measurement. Data derived from the FreeStyle Libre sensor were used to calculate the glucose management indicator (GMI) and glycemic variability (GV) parameters. HGI was defined as the difference between the GMI and the laboratory HbA1c levels. The participants were divided into three groups according to the HGI tertile (low, moderate, and high). Multivariate regression analyses were performed. RESULTS: The female sex ratio, HbA1c, and % coefficient of variation (%CV) significantly increased over the HGI tertile, while eGFR and Hb decreased over the HGI tertile. In multivariate analysis, the factors associated with HGI were %CV and eGFR, after adjusting for HbA1c level and sex (R2  = 0.44). CONCLUSIONS: This study demonstrated that HGI is associated with female sex, eGFR, and some glycemic variability indices, independently of HbA1c. Minimizing glycemic fluctuations might reduce HGI. This information provides diabetic health professionals and patients with personalized diabetes management for adults with type 1 diabetes.

To Use or Not to Use a Self-monitoring of Blood Glucose System? Real-world Flash Glucose Monitoring Patterns Using a Cluster Analysis of the FGM-Japan Study.

Objective This study investigated self-monitoring of blood glucose (SMBG) adherence and flash glucose monitoring patterns using a cluster analysis in Japanese type 1 diabetes (T1D) patients with intermittently scanned continuous glucose monitoring (isCGM). Methods We measured SMBG adherence and performed a data-driven cluster analysis using a hierarchical clustering in T1D patients from Japan using the FreeStyle Libre system. Clusters were based on three variables (testing glucose frequency and referred Libre data for hyperglycemia or hypoglycemia). Patients We enrolled 209 participants. Inclusion criteria were patients with T1D, duration of isCGM use ≥3 months, age ≥20 years old, and regular attendance at the collaborating center. Results The rate of good adherence to SMBG recommended by a doctor was 85.0%. We identified three clusters: cluster 1 (low SMBG test frequency but high reference to Libre data, 17.7%), cluster 2 (high SMBG test frequency but low reference to Libre data, 34.0%), and cluster 3 (high SMBG test frequency and high reference to Libra data, 48.3%). Compared with other clusters, individuals in cluster 1 were younger, those in cluster 2 had a shorter Libre duration, and individuals in cluster 3 had lower time-in-range, higher severe diabetic distress, and high intake of snacks and sweetened beverages. There were no marked differences in the incidence of diabetic complications and rate of wearing the Libre sensor among the clusters. Conclusion We stratified the patients into three subgroups with varied clinical characteristics and CGM metrics. This new substratification might help tailor diabetes management of patients with T1D using isCGM.

Factors associated with hypoglycemia unawareness and severe hypoglycemia in type 1 diabetes mellitus patients.

AIMS/INTRODUCTION: Several factors are associated with hypoglycemia unawareness and severe hypoglycemia, but few large studies have analyzed Japanese patients with type 1 diabetes. The aim of this study was to analyze the risk factors for hypoglycemia unawareness and severe hypoglycemia in Japanese type 1 diabetes patients. MATERIALS AND METHODS: A self-administered questionnaire investigated events, complications and treatments associated with hypoglycemia in patients with type 1 diabetes. Multiple logistic regression analysis of factors associated with hypoglycemia unawareness and severe hypoglycemia requiring medical treatment was carried out. The coefficient of variation (CV) of blood glucose levels was determined using blood samples collected at six outpatient visits. RESULTS: Of the 1,619 participants, 44.2% and 10.4% experienced hypoglycemia unawareness and severe hypoglycemia, respectively. Mean HbA1c levels in patients with hypoglycemia unawareness were lower than those in patients without hypoglycemia unawareness. The type 1 diabetes subtype, glycated hemoglobin (HbA1c) level, CV of blood glucose levels and history of severe hypoglycemia requiring medical treatment were significant independent variables predicting the presence of hypoglycemia unawareness. The glucose CV and a history of hypoglycemia unawareness were significant independent variables predicting severe hypoglycemia requiring medical treatment. In stratified analyses of patients divided into four groups according to glucose CV and HbA1c levels, the high-glucose-CV/low-HbA1c group had the highest odds ratios for hypoglycemia unawareness (2.60) and severe hypoglycemia requiring medical treatment (2.55). CONCLUSIONS: The ambulant glucose CV correlated with both hypoglycemia unawareness and severe hypoglycemia. Patients with high glucose CV and low HbA1c are at high risk of such adverse events, and their treatment strategies should be reviewed.

A sensor augmented pump may improve awareness of hypoglycemia and quality of life in Japanese patients with type 1 diabetes mellitus.

OBJECTIVE: Sensor-augmented pump (SAP) therapy reportedly improves glycemic control and quality of life. However, there is limited information on changes in awareness of hypoglycemia and quality of life (QOL) after starting SAP therapy in Japanese patients with type 1 diabetes. The aim of this study was to evaluate glycemic control, awareness of hypoglycemia, and QOL after initiation of SAP therapy in these patients. METHODS: The study included 20 patients with type 1 diabetes who started SAP therapy. HbA1c levels, values derived from continuous glucose monitoring [including percentages of time in target range (70-180 mg/dL), time below range (< 70 mg/dL), and time above range (> 180 mg/dL)], the Diabetes Treatment Satisfaction Questionnaire score, and the Clarke score were compared between baseline and after 3 and 6 months of SAP therapy. RESULTS: There was a significant decrease in HbA1c at 3 and 6 months after starting on the SAP (p < 0.0001). There was also a significant decrease in time above range (> 180 mg/dL) at the two time points (p = 0.0069 and p = 0.0042, respectively). There was no significant change in time below range (< 70 mg/dL). There was a significant reduction in the Clarke score (p = 0.0347 and p = 0.0003, respectively) and a significant increase in the treatment satisfaction score (both p < 0.0001). There was no significant change in any of the three MOS 36-Item Short-Form Health Survey v2 component summary scores. CONCLUSION: SAP therapy was associated with improvement of glycemic control, mainly by reducing hyperglycemia, and patients' satisfaction with treatment.

Clinical and genetic characteristics of people with type 1 diabetes who have discrepancies in titers of anti-glutamic acid decarboxylase antibody measured by radioimmunoassay and enzyme-linked immunosorbent assay.

AIMS/INTRODUCTION: The aim of the present study was to compare the clinical and genetic characteristics between people with type 1 diabetes who were positive and negative for autoantibodies against glutamic acid decarboxylase (GADA) measured by enzyme-linked immunosorbent assay (ELISA) with low-titer GADA measured by radioimmunoassay. MATERIALS AND METHODS: Among Japanese people with type 1 diabetes in whom GADA were measured by both ELISA and radioimmunoassay, those who had low titers of GADA measured by radioimmunoassay (1.5-10 U/mL), regardless of positivity for GADA measured by ELISA, were studied. There were 65 participants with acute-onset type 1 diabetes and 30 participants with slowly progressive insulin-dependent diabetes mellitus. Clinical characteristics and human leukocyte antigen types were compared in ELISA-positive (≥5 U/mL) and ELISA-negative participants. Endogenous insulin secretion was evaluated by C-peptide index. RESULTS: Among participants with slowly progressive insulin-dependent diabetes mellitus, postprandial C-peptide index was significantly higher in ELISA-negative participants than in ELISA-positive participants (r = 0.619, P = 0.002). Among 52 participants whose human leukocyte antigen typing was carried out, all of the participants with slowly progressive insulin-dependent diabetes mellitus who had DRB1*09:01 were positive by GADA-ELISA (P = 0.021). In acute-onset type 1 diabetes participants, there were no significant differences for the C-peptide index and human leukocyte antigen genotypes. CONCLUSIONS: The difference in the positivity for GADA-ELISA might reflect cytotoxicity toward pancreatic ß-cells and preservation of endogenous insulin secretion in people with slowly progressive insulin-dependent diabetes mellitus. We also suggest that the difference in the GADA-ELISA-specific epitope depends on the human leukocyte antigen genotype.

Treatment Modality-Dependent Risk of Diabetic Ketoacidosis in Patients with Type 1 Diabetes: Danish Adult Diabetes Database Study.

BACKGROUND AND AIMS: The aim of this study was to evaluate the incidence rates of diabetic ketoacidosis (DKA) according to treatment modality in patients with type 1 diabetes (T1D) in Denmark, either multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). MATERIALS AND METHODS: A total of 20,902 T1D registered in the Danish Adult Diabetes Database were followed for an average of 5.4 years. Poisson regression analyses with risk time as offset were used to compare differences in rates of DKA between CSII and MDI. Model was adjusted for age, sex, diabetes duration, previous DKA events, and hemoglobin A1c (HbA1c). A modifying effect of number of CSII patients on the DKA rates was tested. RESULTS: During 113,731 person-years, 3100 DKA events were registered (53 among CSII). CSII patients were younger (42.3 vs. 47.9 years), a larger proportion was female (59% vs. 43%), had a shorter diabetes duration (19 vs. 21 years), and a lower HbA1c (61.9 vs. 66.6 mmol/mol). There was no significant difference in the incidence rate of DKA between CSII and MDI (rate ratio: 1.30, 95% confidence interval: 0.97-1.76). However, in clinics with at least 250 CSII patients, rates of DKA events were lower among CSII users, while the opposite was true for the smaller clinics (P = 0.016). CONCLUSIONS: Delivery of CSII in large diabetes clinics with sufficient support and patient education may ensure that CSII treatment does not lead to an increased risk of DKA.

Relationship between HLA haplotype and BMI change in Japanese slowly progressive type 1 diabetes patients.

We investigated the association between susceptible HLA and BMI change rate from diagnosis of diabetes to diagnosis of slowly progressive type 1 diabetes in Japanese diabetic patients. Subjects with the HLA DRB1*04:05-DQB1*04:01 haplotype were more likely to show weight loss than those without. This HLA haplotype might affect weight loss.