Background and Aims

The aim of the present study was to examine vitamin D status and its relation with bone metabolism in adult patients with T1DM.

Methods

We studied 118 patients with T1DM (Group-D) (mean age:35.4+10.3years) and 94 healthy controls (Group-C) matched for age, sex and BMI. In both groups HbA1c, 25(OH)Vitamin D (Vit-D), Ca, Ph, Mg, ALP, albumin, PTH, β-crosslaps, type 1 procollagen total N-terminal propeptide (TP1NP) were measured. Vit-D levels 30-50ng/ml were defined as optimal concentration(OC), 20-30ng/ml as suboptimal concentration(SC), 10-20ng/ml as deficiency(DE) and 0-10ng/ml as insufficiency(IN).

Results

In Group-D, mean duration of DM was 16.2+9.5years and mean HbA1c was 7.8+1.4%. In Group-D, Vit-D OC occurred in 20%, SC occurred in 27.1%, DE occurred in 34.3%, with the remaining 18.6% having a Vit-D level below 10 ng/m (IN). In Group-C, Vit-D OC occurred in 23.4%, SC occurred in 31.6%, DE occurred in 28.4%, with the remaining 16.6% having a Vit-D level below 10 ng/mL (IN). The overall mean Vit-D levels were not significantly different between groups (D:20.4+11.0vsC:21.2+8.4, p=0.743). Also, Ca, Ph, Mg, ALP and PTH levels were comparable in both groups. B-crosslaps were significant lower in Group-D compared to control (D:325.7+198.9vsC:442.8+220.6, p=0.002) but TP1NP were lower in Group-D but not statistical significant (D:50.34+30.97vsC:53.12+24.43, p=0.594). In T1DM patients, no correlation was found between Vit-D and HbA1c (r=0.032,p=0.794), Vit-D and β-crosslaps (r=-0.004,p=0.976) and Vit-D and TP1NP (r=0.009,p=0.944).

Conclusions

These data suggest that Vit-D and calcium metabolism in patients with T1DM were comparable with the controls and were not correlated with glycemic control and bone metabolism.

Background and Aims

Diabetes mellitus type 2 is a severe chronic disease, characterized by the high risk of lethal complications, primary renal damage and cardio-vascular events. To prevent severe complications, it’s important to focus on the early diagnostics and appropriate management of these conditions. The study was designed to determine the significance of the modern serum and urine biomarkers (NAG, NGAL, osteopontin, clasterin, cystatin C) for the diagnosis and development of the personalized management plan for the patients with type 2 diabetes and associated kidney disease.

Methods

As the first stage of the trial, the 3-year analysis of hospital admissions of patients with type 2 diabetes was conducted. The admission cause, comorbidities and the quality of the diagnostic and management plans were documented. The data analysis was conducted using the standard computer programs. This allowed to gather the initial epidemiological and clinical data as well as to set up the trial sample.

Results

During 3 years, 6120 patients were admitted to internal medicine, 828 had type 2 diabetes (14%). Average age 63,47±7,7 years (37-80), 380 patients (46%) had cardio-vascular complications and 422 patients (51%) had renal complications. 10% of patients required further investigation of the renal complications.

Conclusions

The initial data results confirm the importance of setting the new approaches to the early diagnosis and reasonable personalized treatment for patients with type 2 diabetes and cardio-vascular and renal complications, as this can work as an effective tool for the prevention of further complications and so the improvement of prognosis and the quality of life for such patients.

Background and Aims

The present work was undergone to study the relationship between body mass index, blood pressure and atherosclerosis risk factors on the basis of three lipid ratios by comparing type 1 to type 2 diabetic patients

Methods

Anthropometric parameters, systolic and diastolic blood pressures and lipid profile were evaluated in adult patients with type 1 and type 2 diabetes over a period of eleven months. Individual atherogenic risk factors based on lipid ratios were estimated in relation to corpulence and hypertension.

Results

237 adult diabetic patients; ninety type 1 diabetic patients and one hundred forty seven type 2 diabetics were involved in the study. Total cholesterol (TC)/high-density lipoprotein (HDL) and triglycerides (TG)/HDL ratios were significantly higher in normal weight type 2 diabetic comparing to type 1 diabetic patients. The TC/HDL was significantly higher (p=0.046) in obese men. Nevertheless, no significant differences were revealed regarding low-density lipoprotein (LDL)/HDL ratio between type 1 and type 2 diabetic patients. Higher TC/HDL ratios were observed in type 2 diabetic patients (males and females) with normal blood pressure (systolic blood pressure “SBP”£13.5 mmHG and diastolic blood pressure “DBP”£8 mmHg) comparing to type 1 diabetic patients. Likewise, the LDL/HDL ratio was significantly higher in type 2 diabetic men with normal DBP (p=0.044).

Conclusions

Lipid ratios are good indices while managing diabetes, it is also recommended to screen type 1 and type 2 diabetic patients for hypertension, dyslipidemia, and obesity and to initiate management at early stages to prevent related complications such as atherosclerosis as a priority

Background and Aims

Modern insulin therapy aims to establish good glycemic control without relevant hypoglycaemia. Physiologic insulin secretion can best be mimicked by insulin pump therapy (CSII). The novel catheter featuring Lantern Technology is designed to ensure insulin flow if occlusion from bending, kinking or clogging occurs. The aim of the present study is to investigate clinical performance of the novel Lantern catheter with artificially clogged tip compared to standard infusion set.

Methods

This randomized, controlled, double-blind cross-over trial will enrol 20 adult patients with type 1 diabetes experienced in using CSII. The study comprises two 3-day home CSII treatment phases using: a) the artificially clogged Lantern catheter or b) standard infusion set. All participants will undergo both treatment phases. During home CSII treatment phases subjects will follow their regular lifestyle and diabetes management with CSII therapy. During home phase, continuous glucose monitoring (CGM), capillary glucose and ketone measurements will be performed regularly and data will be downloaded from the devices at the end of the study. Additionally, rescue carbs and rescue insulin doses administered via insulin pen will be recorded in a diary.

Results

Infusion set performance of the novel Lantern catheter with artificially clogged tip will be assessed by CGM data, insulin requirements and adverse events such as occurrence of ketoacidosis, requirement of rescue carbohydrates or rescue insulin doses via pen.

Conclusions

It is expected that the Lantern catheter provides stable insulin delivery even if bending, kinking or clogging of cannula occurs as mimicked by artificially clogging the Lantern catheter.

Background and Aims

Type 1 diabetes (TIDM) is due to insulin deficiency which occurs when the body’s immune system mistakenly attacks and destroys insulin-producing beta cells in the pancreas. It is the most common form of diabetes in children and it is managed with lifelong Insulin therapy for survival. Insulin notwithstanding, efforts are being made to develop other therapeutic strategies. One of such strategies is Immunotherapy which re-programs the immune system. Although with a track record of notched up successes against cancers and autoimmune diseases, immunotherapy has only shown limited success against TIDM in clinical trials. This review looks at the literature on the prospect of immunotherapy with recommendations for future immunotherapy trials in T1DM.

Methods

Literature Review: Google Scholar and PubMed search of Publications on TIDM from 2000 -2019 were reviewed.

Results

Overall, most of the studies demonstrate preliminary promising results.

Conclusions

Future clinical trials should focus on strategies that address fundamental aspects of clinical immunology of TIDM with efforts to incorporate precision medicine trial design.

Background and Aims

Sleep variability (variability in day-to-day sleep schedule) and insufficient sleep duration are increasingly recognized as important contributors to glycemic control in T1D. The purpose of this pilot trial was to evaluate the effects of a T1D-specific sleep optimization intervention (Sleep-Opt-In) on the outcomes of objectively measured sleep variability and duration; and glycemic parameters (glycemic control and variability) in working-age adults with T1D.

Methods

Six adults with T1D completed an 8-week T1D-Sleep-Opt-In intervention. A one-week run-in period was conducted to obtain baseline measures of sleep (actigraphy-derived duration, variability [sleep duration SD]), glycemic control (A1C, Quest®), and glucose variability (CGM-derived CV%, Abbott Libre®). T1D-Sleep-Opt-In entails a novel technology-assisted behavioral sleep intervention employing a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. At completion (Week 8), baseline measures were repeated to determine post-intervention differences.

Results

After the 8-week program there was a reduction in sleep variability, wakefulness after sleep onset and glycemic variability. Those with higher sleep variability (>60 min) responded better: mean sleep variability decreased 17 minutes; mean A1C decreased 0.26%, mean CV% decreased 5.7%.

Conclusions

This pilot study demonstrates proof of concept that those with high sleep variability may benefit from a sleep optimization intervention.

Background and Aims

Metabolic syndrome is a multifactorial heterogenous disorder & marked variability in cholesterol, WC ,BP, lipid profile & FPG has been characterised as components of metabolic syndrome. Metformin and Pioglitazone have been known to decrease insulin resistance. Rosuvastatin targets hyperlipidemia, major component of metabolic syndrome . Statins have pleiotropic effects such as reducing oxidative stress and modulating inflammatory responses.Thus, these drugs may potentially target the underlying pathophysiology and till date there is no randomized controlled trial comparing the effects of these drugs together on various components of metabolic syndrome. Comparative effects of these treatments on markers of insulin resistance and inflammation have not yet been reported.

Aims:- To evaluate and compare the effects of metformin, pioglitazone and rosuvastatin on various parameters of metabolic syndrome & on levels of insulin sensitizers (adiponectin) and markers of inflammation (hsCRP) in cases with MetS.

Methods

The current study was planned to evaluate & compare various potential treatments for the patients of metabolic syndrome. A prospective , open label, parallel group & randomized control trial of 12 weeks study duration was selected in which patients were randomly assigned in 4 groups to receive diet & lifestyle modification, Metformin, Pioglitazone, Rosuvastatin.

Results

There was no significant difference between the groups in any baseline parameter & all 4 groups were comparable to each other at baseline.

EFFECT ON BIOCHEMICAL PARAMETERS :-

Conclusions

Only Rosuvastatin brought about significant increase in serum HDL which is a major marker of cardiovascular risk. Pioglitazone & Rosuvastatin were better than Metformin & lifestyle modification in reduction of serum triglycerides.

Background and Aims

Background

The prevalence of diabetes in Zimbabwe is 9.7% (International Diabetes Federation, 2015). Prevalence of 8.8% and 6.6% has been reported for diabetes in pregnancy and GDM respectively in studies done in Zimbabwe (Nhidza et al., 2017). Health education was reported in a previous study done in Zimbabwe as one of the facilitators of adherence to diet, physical activity and medications. (Mukona et al., 2017). Purpose of this study is to evaluate the effectiveness of an educational intervention on adherence to therapy and perinatal outcomes in pregnant women with diabetes.

Aims

To evaluate the effectiveness of an educational intervention in pregnant women with diabetes on:

Adherence to diet, physical activity and medications

Glycaemic control

Perinatal outcomes occurring from the 20^th week of gestation to the 21^st day after delivery

Methods

METHODS

An RCT conducted on 96 (48 per arm) pregnant women with diabetes in pregnancy at Mbuya Nehanda and Harare maternity hospitals.

Block stratified random sampling based on type of diabetes (type I, type II and GDM) will be done. Educational intevention will be done to the study group. . Structured questionnaires will be used to collect data together with glycated haemoglobin and fasting blood glucose

10 Procedures

Assessing adherence to diet, physical activity and medications, HbA1C, FBG andImplementation of the educational intervention to the study group and perinatal outcomes.

11 Data analysis- STATA version 15.

Results

No results yet. Data collection has not started

Conclusions

Not concluded yet

Background and Aims

IgG4 and Lactoferrin (ALF) autoantibodies (Ab) prevalence in different duration type 1 diabetes mellitus (T1D).

Methods

A total of 78 patients (41 men, 37 women) with T1D were included in the study. Patients were divided in 2 groups, according to T1D duration. All patients underwent an immunological study, which included the determination of IgG4 and ALF Ab.The patients were also examined for pancreatic b-cell Aab, C-peptide, HbA1c. Ab to IgG4, ALF, glutamic acid decarboxylase (GADA), tyrosine phosphatase-like IA-2 (IA-2A) and zinc T8 (ZnT8A) were detected by ELISA.

Results

Table 1. Patients characteristics

Table 2. Pancreatic β-cell Ab positive titres

All of 78 patients with T1D were negative for ALF Aab. In group "a" all patients were negative for IgG4 and in group "b" 3 (6,5%) were positive (Aab levels – 4897,2; 3813,7; 3479,6). We didn't find association between IgG4, ALF levels and HbA1C, fasting c-peptide and b-cell Ab p<0,05. Patients in group "b" had higher IgG4 and ALF than in group "a", p<0,05.

Conclusions

The present data didn’t confirm the high presence of IgG4 and ALF in T1D, but higher Ab levels was found in long-standing T1D.

Background and Aims

With various hypoglycemic agents (HAs) now available, the optimal treatment order and combination therapies for type 2 diabetes patients remains debatable. In this study, we aimed to clarify the current treatment patterns of Japanese type 2 diabetes patients using glucagon-like peptide-1 receptor agonist (GLP-1RA).

Methods

Data on patients using GLP-1RA was retrospectively collected from the Jikei University Hospital electronic health record system using the Standardized Structured Medical record Information eXchange (SS-MIX) from January 2017 to September 2018. Descriptive analysis to compare patient demographics and other HA use among patients divided by the timing of GLP-1RA administration was performed.

Results

In this study, 145 patients on GLP-1RA were identified from over 6,000 type 2 diabetes patients. Patients on GLP-1RA demonstrated a mean age of 64.5 years, mean HbA1c of 8.4% with a mean duration of diabetes history of 7.3 years. Among these patients, 71 patients received liraglutide (48.9%) and 66 received dulaglutide (47.5%). GLP-1RA was prescribed as first line therapy in 1.4%, second-line in 17.3%, third-line in 31.7%, fourth-line in 27.3%, fifth-line in 15.8%, and sixth-line in 6.5%.Overall, patients with a history of cardiovascular disease or heart failure (p=0.026), age older than 75 years (p=0.015),and those with renal dysfunction (p=0.027) received GLP-1RA at a significantly earlier timing.

Conclusions

In our institution, GLP-1RA was most frequently prescribed as third or fourth-line HA especially for those with known cardiovascular disease, higher age and renal dysfunction.

Background and Aims

There are beneficial effects of both the use of advanced carbohydrate counting with an automatic bolus calculator (ABC) and intermittently scanned continuous glucose monitoring (isCGM). The aim of this study is to compare the effects on glycemic control of isCGM, and/or training in carbohydrate counting with ABC vs. standard treatment in persons naïve to both interventions.

Methods

A randomized controlled trial carried out at five sites in The Capital Region, Denmark, with inclusion criteria; ≥18 years, T1D ≥1 year, HbA1c >53 mmol/mol, MDI therapy, whereas use of advanced carbohydrate counting / CGM wear are exclusion criteria. Inclusion was initiated in August 2018 and is ongoing. Eligible persons are randomized into 4 groups; A (control), B (ABC), C (isCGM) or D (ABC + isCGM). The devices used are smart phone MySugr application and FreeStyle Libre flash (Abbott Diabetes Care). Participants attend group courses of 4.5 hours duration according to group allocation with different educational content; general diabetes, ABC, MySugr app, FreeStyle Libre Flash and advanced FreeStyle Libre Flash. Participants are followed for 26 weeks with 6 clinical visits. At baseline and at study end, participants wear blinded CGM (FreeStyle Libre Professional, Abbott Diabetes Care), have blood samples performed (HbA1c, safety) and fill in questionnaires (PAID, DTSQ, DES-SF and ADDQoL-19). At baseline, they also filled in NEO-FFI-3.

Results

The primary outcome is the difference at study end vs. baseline between groups C (isCGM) and A (control) in time spent in normoglycemia (4-10 mmol/l). Secondary outcomes will also be analyzed.

Conclusions

Results are expected in 2020.

Background and Aims

This study was aimed at investigating changes over time in lines of therapy (LOT) for SGLT2 inhibitors (SGLT2i) among type 2 diabetes (T2D) patients newly prescribed these agents and their characteristics in Japan.

Methods

Data of T2D outpatients of our hospital since 1-1-2016 who received SGLT2i from the Standardized Structured Medical record Information eXchange 2 (SS-MIX2) was used. Among 620 patients, 369 patients were selected except those treated with polypharmacy including SGLT2i at referral and type 1 diabetes. Data included patient age at initial prescription of SGLT2i, duration of disease, body mass index (BMI), HbA1c value, history of cardiovascular (CV) events, and LOT for which SGLT2i had been prescribed. We used the Mann-Whitney test to compare before and after 1-1-2017.

Results

The patient’s characteristics [median (25-75%)] were following: age, 59.0 (49.0-68.0) years old; duration of disease, 6.0 (3.0-10.0) years; BMI, 27.1 (24.3-30.8) kg/m²; HbA1c, 8.1 (7.5-9.1) %; and history of CV events, 88 (23.8)%. Again, LOT for SGLT2i had been used in 3^rd (2^nd to 4^th). SGLT2i were newly prescribed for 123 patients before 12-31-2016 (33.3 )%. SGLT2i were significantly more frequently prescribed in patients with a history of CV events from 2017 onwards (P = 0.006) and in earlier LOT in 2017 than in 2016 (P = 0.001).

Conclusions

This study revealed that SGLT2i were more frequently prescribed in patients with a history of CV events and in earlier LOT after 1-1-2017 than before.

Background and Aims

Little information is available regarding the relationship between insulin resistance (IR) and fatty liver index (FLI) in children in a population-based setting.

Methods

The study included a total of 56 ninth-grade children participating in check-up programs implemented in Tsunan Town, Niigata, Japan (boys/girls, 32/24). IR was defined as homeostasis model assessment (HOMA)-R ≧2.5. FLI was calculated using waist circumference, BMI, γGTP, TG, and FLI ≧60 was defined as fatty liver. Correlations between these parameters were evaluated using the Spearman’s correlation test.

Results

The medians (25-75thpercentiles) of HOMA of IR , FLI and body mass index in boys were 1.9 (1.3-3.0), 2.7 (1.7-3.9) and 19.3 (18.1-21.4)kg/m², respectively, vs 2.1 (1.6-4.4), 4.6 (1.9-12.5) and 21.5 (20.0-25.3)kg/m² in girls, respectively. Those with IR were not significantly different between girls and boys (41.7/28.7%; P=0.254). FLI tended to be higher proportion of girls than boys (8.3/3.1%; P=0.091). The correlation between IR and FLI was significant only in girls but not in boys (r = 0.705; P < 0.001, r = -0.012; P = 0.952).

Conclusions

The correlation between FLI and IR was examined in Japanese school children aged 14 to 15 years old. IR was significantly correlated with FLI in girls. Therefore, IR could be a potential indicator for predicting fatty liver in girls.

Background and Aims

To explore the mechanism of Exenatide reduces the apoptosis of diabetic neonatal cardiomyocyte

Methods

We used a high glucose/palmitate intervention to mimic Type 2 diabetes in vitro. Neonatal cardiomyocytes were divided into control group(C); diabetes group (D), diabetes treated with Exenatide group(DE); diabetes and block the expression of APPL1 group(DB); diabetes treated with Exenatide and block the expression of APPL1 group (BE). We detected apoptosis rate of cardiomyocytes by TUNEL, the adiponectin levels by ELISA, and the protein expression of APPL1, p-AMPK/T-AMPK, PPARα, and NF-κB by western blotting.

Results

Compared with those in the D group, the level of apoptosis in the C and DE groups was significantly decreased (P<0.05); the concentrations of adiponectin was significantly increased (P<0.05); the expression levels of APPL1, p-AMPK/T-AMPK, PPARα were significantly increased (P<0.05); and the expression levels of NF-κB were decreased (P<0.05). Compared with those in the DB group, the cardiomyocyte apoptosis rate was increased; the expression levels of APPL1, p-AMPK/T-AMPK, PPARα were decreased (P<0.05); the expression levels of NF-κB was significantly increased (P<0.05); and the concentrations of adiponectin was significantly decreased (P<0.05) in BE group.

Conclusions

After diabetic cardiomyocyte were treated with Exenatide, the concentrations of adiponectin was increased, the expression level of the APPL1-AMPK-PPARα axis was increased, and the expression of NF-κB and cardiomyocyte apoptosis rate were decreased, block the expression of APPL1 can reverse this effect.

Background and Aims

MC4R gene encodes melanocortin receptor type 4. The association of rs17782313 polymorphism MC4R gene with the obesity is proved.

The aim of study is to analyze the changes in body fat mass due to the rs17782313 T/C MC4R gene in overweight patients after 3 and 12 months of diet.

Methods

The study involved 16 overweight patients (the mean BMI 34.08±5.59 kg/m2) from 23 to 60 y.o. (the mean age 47.5±11.78). All patients took a balanced diet with the exclusion of simple and the limiting of complex carbohydrates and fats. The changes in body composition were estimated by the bioelectrical impedance analysis. Buccal cells PCR-based genotyping was performed on CFX96 amplifier.

Results

The distribution of rs17782313 polymorphism genotypes corresponded to the Hardy-Weinberg equilibrium (χ2 = 0.17; p = 0.68). The frequency of occurrence of the C allele differed from the European population (9% 24%; 1000 Genomes Project), which can be explained by the small sample size. TT homozygotes showed a significant decrease in body fat mass after 3 months of diet (p= 0.007) compared with C allele carriers (-4.56 ± 2.55 kg vs. + 0.38 ± 1.66 kg). There were no significant differences in changes in body composition in TT homozygotes compared with C-allele carriers after 12 months of diet (p> 0.05).

Conclusions

The presence of the C allele in the homozygous state of the rs17782313 MC4R is associated with less decreasing of fat mass during the 3 months of a generally accepted diet, no further differences in changes in body composition are observed.

Background and Aims

ADRB2 is the gene that encodes beta-2 adrenergic receptors which play the key role in the mobilization of lipids.

The aim of work is to study the changes in body composition depending on the rs1042713 ADRB2 gene in overweight patients treated by the diet.

Methods

18 overweight patients (from 23 to 60 y.o., the mean age 45,39±12,71; the mean BMI 33,71±5,48 kg/m2) were evaluated. All patients took a diet with limiting of simplex and complex carbohydrates and fats for 3 months. Body composition was evaluated by bioelectrical impedance analysis (BIA). PCR-based genotyping was performed on CFX96 analisator; buccal cells were used.

Results

The distribution of the frequency of alleles and genotypes corresponded to the Hardy-Weinberg equilibrium (χ2=0,000172531; p>0,05). A significant decrease of fat mass in patients with the absence of G-allele (-5,67±2,55 kg) relative to the group of carriers of the mutant allele (-2,73±2,759 kg; p=0,05) was revealed. All patients were invited for BIA 9 months after. Although there were no significant differences in changes of fat mass between the groups, G-allele carriers had less weight gain than the patients with the absence of the mutant allele. (0,22±2,24 kg vs. 2,44±2,02 kg; p=0,04).

Conclusions

Identification of the allele G of rs1042713 ADRB2 gene allows predicting a less intense loss of body fat mass during the common diet therapy of obesity and prognosing worse weight control in future.

Background and Aims

The aim of our study was to verify the adherence to metformin treatment by determining its serum levels during a routine outpatient control.

Methods

208 patients with type 2 diabetes mellitus from a single tertiary diabetes centre (aged 68.0±8.9 years, HbA_1C 56.0±13.4 mmol/mol) using standard or XR (sustained release) form of metformin were included in the study. Blood sampling for metformin was performed during a regular outpatient visit. Hydrophilic interaction chromatography (HILIC) and high resolution mass spectrometry (Q Exactive Plus instrumentation) were used to quantify metformin levels.

Results

In the whole group, mean metformin levels reached 1480.4±1110.0 ng/ml, while not significantly differing between the standard and XR form. Inadequate values ​​(<100 ng/ml) were measured in 6.7% of subjects, whereas in 2.4% metformin was not detected at all. The presence of subtherapeutic levels was not affected by the administration of XR form (6.3 vs. 8.3% for standard vs. XR, n.s.). In 11.0% of patients, metformin was part of a combination preparation with another antidiabetic drug, with none of the subjects showing sub-therapeutic levels. No difference between patients with optimal and sub-therapeutic metformin values was seen in fasting glucose (8.1±2.6 vs. 8.7±3.6 mmol/l, n.s), HbA_1C (55.6±13.3 vs. 58.4±14.8 mmol/mol, n.s.) or BMI (30.6±4.7 vs. 31.3±4.4 kg/m²).

Conclusions

In a tertiary diabetes centre the compliance with metformin treatment was greater than 93% and increased with the use of combination preparations, while the XR form was not associated with a higher adherence rate.

Acknowledgements: MZ CR–RVO (IKEM, IC 00023001) and RVO VFN64165.

Background and Aims

To investigate the effect of intermittent-scanning CGM (isCGM) together with structured education focused on the utilization of the trend arrow to prevent hypoglycemia in patients with type 1 diabetes mellitus, we planned a crossover study comparing FreeStyle Libre and self-monitoring of blood glucose (SMBG).

Methods

The ISCHIA study is a multicenter, prospective, open-label, randomized crossover study of patients with type 1 diabetes mellitus to compare isCGM and SMBG. The Intervention arm uses isCGM together with structured education to prevent hypoglycemia and SMBG 3 times a day or more. The control arm uses SMBG 3 times a day or more and retrospective CGM whose results are masked for the study participants. The study includes 28-day run-in period, 84-days sequence 1, 28-day washout period, and 84-day sequence 2. Participants were randomly assigned to Group A (Intervention/ Control) or Group B (Control / Intervention) in a 1:1 ratio. The primary endpoint is the time spent in hypoglycemia (<70 mg/ dL) per day (hour/day) between the Intervention arm and Control arm. The secondary endpoints include other CGM metrics, the quality of life (QOL), patients’ adherence and cost-effectiveness.

Results

The study was launched on March 15, 2019 at 8 institutes.

Conclusions

This study will be the first randomized crossover study of patients with type 1 diabetes mellitus evaluating the effect of the usage of isCGM together with structured education to prevent hypoglycemia in Japan. (jRCT: jRCT1052180075)