Continuous glucose monitoring with structured education in adults with type 2 diabetes managed by multiple daily insulin injections: a multicentre randomised controlled trial.

AIMS/HYPOTHESIS: The aim of this study was to compare the effectiveness of stand-alone intermittently scanned continuous glucose monitoring (isCGM) with or without a structured education programme and blood glucose monitoring (BGM) in adults with type 2 diabetes on multiple daily insulin injections (MDI). METHODS: In this 24 week randomised open-label multicentre trial, adults with type 2 diabetes on intensive insulin therapy with HbA1c levels of 58-108 mmol/mol (7.5-12.0%) were randomly assigned in a 1:1:1 ratio to isCGM with a structured education programme on adjusting insulin dose and timing according to graphical patterns in CGM (intervention group), isCGM with conventional education (control group 1) or BGM with conventional education (control group 2). Block randomisation was conducted by an independent statistician. Due to the nature of the intervention, blinding of participants and investigators was not possible. The primary outcome was change in HbA1c from baseline at 24 weeks, assessed using ANCOVA with the baseline value as a covariate. RESULTS: A total of 159 individuals were randomised (n=53 for each group); 148 were included in the full analysis set, with 52 in the intervention group, 49 in control group 1 and 47 in control group 2. The mean (± SD) HbA1c level at baseline was 68.19±10.94 mmol/mol (8.39±1.00%). The least squares mean change (± SEM) from baseline HbA1c at 24 weeks was -10.96±1.35 mmol/mol (-1.00±0.12%) in the intervention group, -6.87±1.39 mmol/mol (-0.63±0.13%) in control group 1 (p=0.0367 vs intervention group) and -6.32±1.42 mmol/mol (-0.58±0.13%) in control group 2 (p=0.0193 vs intervention group). Adverse events occurred in 28.85% (15/52) of individuals in the intervention group, 26.42% (14/53) in control group 1 and 48.08% (25/52) in control group 2. CONCLUSIONS/INTERPRETATION: Stand-alone isCGM offers a greater reduction in HbA1c in adults with type 2 diabetes on MDI when education on the interpretation of graphical patterns in CGM is provided. TRIAL REGISTRATION: ClinicalTrials.gov NCT04926623. FUNDING: This study was supported by Daewoong Pharmaceutical Co., Ltd.

Effect of structured individualized education on continuous glucose monitoring use in poorly controlled patients with type 1 diabetes: A randomized controlled trial.

AIM: We aimed to evaluate the efficacy of structured individualized education combined with real-time continuous glucose monitoring (rt-CGM) on glycemic outcomes in adults with type 1 diabetes. METHODS: This was a single-center, 3-month, randomized controlled trial of 47 adults with type 1 diabetes with HbA1c ≥ 7.0% (53 mmol/mol). Study participants were assigned randomly (1:1) to a structured education group or control group. The control group received the same education as the intervention group in a 3-month extension study. The primary outcome was the mean difference in time in range (TIR 70-180 mg/dL [3.9-10.0 mmol/L]) between groups. RESULTS: TIR was higher for the education group than the control group (63.4% vs. 44.5%), resulting in a between-group difference of 15.3% (95% CI 7.9 to 22.8, p < 0.001) at week 12. HbA1c decreased 0.5% (5.5 mmol/mol) more in the intervention group than the control group at week 12 (-0.1 to -1.0, p < 0.001). In the extension period, TIR increased significantly (8.9% [2.2 to 15.6], p = 0.01) in educated control group. CONCLUSIONS: In adults with type 1 diabetes, rt-CGM use with individualized education resulted in better TIR than rt-CGM alone, highlighting the importance of personalized structured education when using rt-CGM. (ClinicalTrials.gov, number NCT03794934).

The relationship between age of onset and risk factors including family history and life style in Korean population with type 2 diabetes mellitus.

[Purpose] The purpose of the present study was to assess the relationship between age of onset and risk factors including family history and life style in Korean population with type 2 diabetes mellitus (T2D). [Subjects and Methods] Subjects with T2D patients who received outpatient care for blood sugar control were randomly sampled at 13 general hospitals and 969 subjects were included. Cox proportional hazard models were used to confirm associations between age of onset and risk factors including family history and life style in Korean population with T2D. [Results] Parent history of T2D was significantly associated with age of onset. Compared to none of family members with T2D, those whose both father and mother had a history showed the highest the risk of early-onset (HR=2.36; 95% CI=1.45-3.85). Mother and father's history of T2D (HR=1.73; 95% CI=1.46-2.05; HR=1.83; 95% CI=1.40-2.37) were associated with the risk of early-onset. Moreover, exercise (HR=1.23, CI=1.08-1.40) smoking status (HR=1.62, CI=1.32-1.99), and drinking (HR=1.32, CI=1.13-1.54) were associated with a higher risk for the early-onset. [Conclusion] Family history as well as life style including exercise, smoking, and drinking are the risk factors for early-onset factor in Korean population with T2D.

Validation of the health literacy scale for diabetes as a criterion-referenced test with standard setting procedures.

OBJECTIVE: To develop and examine the psychometric properties of the Korean Health Literacy Scale for Diabetes Mellitus (KHLS-DM), and to establish reasonable cutoff scores. METHODS: Initially, 299 items were generated to measure diabetes-related words, numeracy, and information utilization. Content validity assessment and preliminary tests were conducted. After exploratory factor analysis (EFA) and Rasch analysis, the remaining 65 items were administered to a quota sample of 500 diabetic patients aged 40-74 years. The items were narrowed down to 58 items based on an item fit index. To obtain cutoff scores, Jaeger's method and the Bookmark method were employed. RESULTS: A confirmatory factor analysis (CFA) was performed, and a three-factor model was supported (χ2/df = 3.891, CFI = 0.92, TLI = 0.91, RMSEA = 0.04). The overall scores ranged from 0 to 58, and two cutoff points were established. The scale exhibited good internal consistency (Cronbach's α = 0.83). CONCLUSIONS: The KHLS-DM is a reliable and valid measure with cutoff points to classify individuals into three groups (adequate, marginal, and inadequate). PRACTICE IMPLICATIONS: The standard setting may be useful for researchers to validate health literacy measures in other countries and populations.

Diabetes Camp as Continuing Education for Diabetes Self-Management in Middle-Aged and Elderly People with Type 2 Diabetes Mellitus.

BACKGROUND: Despite the established benefits of diabetes camps for the continuing education of children with type 1 diabetes mellitus, little is known about the long-term metabolic benefits of diabetes camps for middle-aged and elderly people with type 2 diabetes mellitus (T2DM), especially in terms of glycosylated hemoglobin (HbA1c) variability. METHODS: The 1-year mean and variability of HbA1c before and after the diabetes camp was compared between the participants of the diabetes camp (n=57; median age 65 years [range, 50 to 86 years]; median diabetes duration 14 years [range, 1 to 48 years]). Additional case-control analysis compared the metabolic outcomes of the participants of the diabetes camp and their propensity score-matched controls who underwent conventional diabetes education (n=93). RESULTS: The levels of HbA1c during the first year after the diabetes camp were comparable to those of the matched controls (P=0.341). In an analysis of all participants of the diabetes camp, the 1-year mean±standard deviation (SD) of HbA1c decreased (P=0.010 and P=0.041) after the diabetes camp, whereas the adjusted SD and coefficient of variance (CV) of HbA1c did not decrease. The adjusted SD and CV significantly decreased after the diabetes camp in participants whose 1-year mean HbA1c was ≥6.5% before the diabetes camp (n=40) and those with a duration of diabetes less than 15 years (n=32). CONCLUSION: The 1-year mean and SD of HbA1c decreased after the diabetes camp, with significant reduction in the adjusted SD and CV in those with higher baseline HbA1c and a shorter duration of diabetes.

Current Status of Management in Type 2 Diabetes Mellitus at General Hospitals in South Korea.

BACKGROUND: In Korea, the prevalence, complications, and mortality rate of diabetes are rapidly increasing. However, investigations on the actual condition of diabetes management are very limited due to lack of nation-wide research or multicenter study. Hence, we have minutely inquired the current status of diabetes management and achievement of glucose target goal in general hospital offering education program. That way, we are able to furnish data for policy making of diabetes education and draw up guideline which may allow us to reduce the morbidity and mortality of diabetes. METHODS: The subjects consisted of 2,610 patients with type 2 diabetes who visited the 13 general hospital in Seoul or Gyeonggi region from March 19 to May 29, 2013. General characteristics, associated diseases, complications, and management status were investigated. RESULTS: The mean age was 61.0±11.6 years, body mass index was 25.0±3.3 kg/m(2), and family history of diabetes was 50.5%. The mean duration of diabetes was 10.7±7.9 years and 53% received education about diabetes. The prevalence of hypertension and dyslipidemia were 59.2% and 65.5%, respectively, and 18.3% of the subjects were accompanied by liver disease. Diabetic retinopathy appeared in 31.6%, nephropathy in 28.1%, and neuropathy in 19.9% of the subjects. The mean glycosylated hemoglobin (HbA1c) level was 7.3%±1.3% and the achieving rate based on Korean Diabetes Association guideline (HbA1c <6.5%) was 24.8%, blood pressure (130/80 mm Hg or less) was 49.4%, and low density lipoprotein cholesterol (<100 mg/dL) was 63.6%. The reaching rate to the target level in four parameters (blood glucose, blood pressure, lipids, and body weight) was 7.8%. CONCLUSION: The blood glucose control rate was lower than other parameters, and the implementation rate of diabetes education was only 53%. Thus more appropriate glucose control and systematic diabetes education are imperative.

Exercise is associated with metabolism regulation and complications in Korean patients with type 2 diabetes.

[Purpose] The aim of the present study was to investigate the current evidence for the effect of exercise on glycemic control, the lipid profile, body composition, vascular health, and complications in Korean patients with type 2 diabetes. [Subjects and Methods] The subjects were 1,263 patients receiving outpatient care at 13 general hospitals located in Seoul and Gyeonggido who were subjected to examinations in the areas of blood glucose management, complications management, and diabetes education between March 19 and May 29, 2013. The relations between exercise and various regulatory factors including patient's general and clinical characteristics, metabolic regulation, achievement of goals for metabolic regulation, and complication incidence in patients with type 2 diabetes were investigated. [Results] Exercise management was associated with a decrease in systolic blood pressure, fasting glucose, postprandial glucose, hemoglobin A1c, total cholesterol, triglyceride, and low-density lipoprotein Regarding achievement of goals for metabolic regulation, significant odds ratios were observed for the effect of exercise treatment on blood pressure, fasting glucose, postprandial glucose, hemoglobin A1c, triglyceride, HDL in men, and BMI in patients with type 2 diabetes. Moreover, exercise management was associated with decreased occurrence of cerebrovasculopathy. [Conclusion] In conclusion, exercise induced metabolic regulation of glycemic control, the lipid profile, and body composition, as well as vascular health and complications, in Korean patients with type 2 diabetes.

The appropriateness of the length of insulin needles based on determination of skin and subcutaneous fat thickness in the abdomen and upper arm in patients with type 2 diabetes.

BACKGROUND: Longer needle and complicated insulin injection technique such as injecting at a 45-degree angle and making skinfolds may decrease patient compliance to insulin injection therapy. In this light, shorter insulin needles have been recently developed. However, it is necessary to ascertain that such shorter needles are appropriate for Korean patients with diabetes as well. METHODS: First, the diverse demographic and diabetic features of 156 Korean adults with diabetes were collected by a questionnaire and a device unit of body fat measurement. The skin and subcutaneous fat thicknesses of each subject were measured by Ultrasound device with a 7- to 12-MHz probe. Data were analyzed using analysis of variance and multiple linear regression. RESULTS: The mean skin thickness was 2.29±0.37 mm in the abdomen and 2.00±0.34 mm in the upper arms, and the mean subcutaneous fat thickness was to 10.15±6.54 mm in the abdomen and 5.50±2.68 mm in the upper arms. Our analysis showed that the factors affecting the skin thickness of the abdomen and upper arms were gender and body mass index (BMI), whereas the factors influencing the subcutaneous fat thickness in the abdomen were gender and BMI, and the factors influencing the subcutaneous fat thickness in the upper arms were gender, BMI, and age. Insulin fluids may not appear to be intradermally injected into the abdomen and upper arms at any needle lengths. The risk of intramuscular injection is likely to increase with longer insulin needles and lower BMI. CONCLUSION: It is recommended to fully inform the patients about the lengths of needles for insulin injections. As for the recommended needle length, the findings of this study indicate that needles as short as 4 mm are sufficient to deliver insulin for Korean patients with diabetes.

A randomized controlled trial of an internet-based mentoring program for type 1 diabetes patients with inadequate glycemic control.

BACKGROUND: To determine whether an internet-based mentoring program can improve glycemic control in subjects with type 1 diabetes mellitus (T1DM). METHODS: Subjects with T1DM on intensive insulin therapy and with hemoglobin A1c (HbA1c) ≥8.0% were randomized to mentored (glucometer transmission with feedback from mentors) or control (glucometer transmission without feedback) groups and were examined for 12 weeks. Five mentors were interviewed and selected, of which two were T1DM patients themselves and three were parents with at least one child diagnosed with T1DM since more than 5 years ago. RESULTS: A total of 57 T1DM adult subjects with a mean duration after being diagnosed with diabetes of 7.4 years were recruited from Samsung Medical Center. Unfortunately, the mentored group failed to show significant improvements in HbA1c levels or other outcomes, including the quality of life, after completion of the study. However, the mentored group monitored their blood glucose (1.41 vs. 0.30) and logged into our website (http://ubisens.co.kr/) more frequently (20.59 times vs. 5.07 times) than the control group. CONCLUSION: A 12-week internet-based mentoring program for T1DM patients with inadequate glycemic control did not prove to be superior to the usual follow-up. However, the noted increase in the subjects' frequency of blood glucose monitoring may lead to clinical benefits.