A Telemedicine System Intervention for Patients With Type 1 Diabetes: Pilot Feasibility Crossover Intervention Study.

BACKGROUND: Today's diabetes-oriented telemedicine systems can gather and analyze many parameters like blood glucose levels, carbohydrate intake, insulin doses, and physical activity levels (steps). Information collected can be presented to patients in a variety of graphical outputs. Despite the availability of several technical means, a large percentage of patients do not reach the goals established in their diabetes treatment. OBJECTIVE: The objective of the study was to evaluate the benefits of the Diani telemedicine system for the treatment of patients with type 1 diabetes mellitus. METHODS: Data were collected during a 24-week feasibility study. Patients responded to the World Health Organization Quality of Life - BREF (WHOQOL-BREF) questionnaire and a system evaluation questionnaire. The level of glycated hemoglobin (HbA1c) and the patient's body weight were measured, and the patient's use of the telemedicine system and their daily physical activity level were monitored. All data were sent from the patient's device to the Diani server using a real-time diabetes diary app. Wilcoxon and Friedman tests and the linear mixed effects method were used for data analysis. RESULTS: This study involved 10 patients (men: n=5; women: n=5), with a mean age of 47.7 (SD 19.3) years, a mean duration of diabetes of 10.5 (SD 8.6) years, and a mean HbA1c value of 59.5 (SD 6.7) mmol/mol. The median number of days the patients used the system was 84. After the intervention, the mean HbA1c decreased by 4.35 mmol/mol (P=.01). The patients spent 18.6 (SD 6.8) minutes on average using the app daily. After the intervention, the number of patients who measured their blood glucose level at least 3 times a day increased by 30%. The graphical visualization of the monitored parameters, automatic transmission of measured data from the glucometer, compatibility, and interconnection of individual devices when entering data were positively evaluated by patients. CONCLUSIONS: The Diani system was found to be beneficial for patients with type 1 diabetes mellitus in terms of managing their disease. Patients perceived it positively; it strengthened their knowledge of diabetes and their understanding of the influences of the measured values on the management of their disease. Its use had a positive effect on the HbA1c level.

Characterization of Individualized Glycemic Excursions during a Standardized Bout of Hypoglycemia-Inducing Exercise and Subsequent Hypoglycemia Treatment-A Pilot Study.

The glycemic response to ingested glucose for the treatment of hypoglycemia following exercise in type 1 diabetes patients has never been studied. Therefore, we aimed to characterize glucose dynamics during a standardized bout of hypoglycemia-inducing exercise and the subsequent hypoglycemia treatment with the oral ingestion of glucose. Ten male patients with type 1 diabetes performed a standardized bout of cycling exercise using an electrically braked ergometer at a target heart rate (THR) of 50% of the individual heart rate reserve, determined using the Karvonen equation. Exercise was terminated when hypoglycemia was reached, followed by immediate hypoglycemia treatment with the oral ingestion of 20 g of glucose. Arterialized blood glucose (ABG) levels were monitored at 5 min intervals during exercise and for 60 min during recovery. During exercise, ABG decreased at a mean rate of 0.11 ± 0.03 mmol/L·min-1 (minimum: 0.07, maximum: 0.17 mmol/L·min-1). During recovery, ABG increased at a mean rate of 0.13 ± 0.05 mmol/L·min-1 (minimum: 0.06, maximum: 0.19 mmol/L·min-1). Moreover, 20 g of glucose maintained recovery from hypoglycemia throughout the 60 min postexercise observation window.

Insulin Management of Patients with Inadequately Controlled Type 2 Diabetes Admitted to Hospital: Titration Patterns and Frequency of Hypoglycemia as Results of a Prospective Observational Study (Hospital Study).

INTRODUCTION: Despite the continuously growing number of therapeutic options for type 2 diabetes mellitus (T2DM) including insulins, a large percentage of patients fail to achieve HbA1c targets. Several real-world studies focused on patients with T2DM receiving insulin treatment in outpatient settings were conducted, but information about real-world in-hospital insulin management is lacking. The aim of this study was to describe the management of insulin therapy with a focus on basal-bolus and premixed insulin regimens in patients with T2DM under routine in-hospital medical practice in the Czech Republic. METHODS: This non-interventional prospective study was conducted from June 2014 to December 2017 in 22 centers in the Czech Republic under routine clinical practice conditions. Adult patients admitted to hospital with metabolically uncontrolled T2DM [HbA1c ≥ 60 mmol/mol; > 7.6% Diabetes Control and Complications Trial (DCCT)] and there treated with basal-bolus and premixed insulin regimens were documented during hospitalization. RESULTS: Overall, 369 patients with T2DM (54.7% male, mean age 64.44 ± 13.84 years, BMI 31.10 ± 6.00 kg/m2, duration of diabetes 8.11 ± 9.93 years, HbA1c 95.90 ± 24.38 mmol/mol, length of stay was 7.94 ± 4.53 days) were included. The percentage of glucose values under 10 mmol/l at time of randomization (the group with basal-bolus insulin regimen vs. the premix insulin regimen group) was 24.2% vs. 33.5% (p = 0.053), at time of first insulin dose adjustment it was 43.1% vs. 50.0% (p = 0.330), and 1 day before hospital discharge it was 61.7% vs. 61.4% (p = 0.107). A hypoglycemic event occurred in a total of 15 patients in the basal-bolus regimen group, and no hypoglycemic event occurred in the premixed insulin regimen group. CONCLUSION: In-hospital insulin management regarding basal-bolus and premixed insulin regimens is safe and in concordance with current international recommendations.

Continuous glucose monitoring - a new and expanding element in the care of patients with diabetes mellitus during pregnancy.

A new parameter of metabolic control derived from the results of continuous blood glucose monitoring is time in range (TIR). According to current recommendations, in pregnant women with diabetes, this glycemic range is defined by values of 3.5 to 7.8 mmol/L, with the aim of keeping glycemia in this range as much time as possible, and at the same time reducing the time spent below its lower limit (< 3.5 mmol/L)). In pre-gestational type 1 diabetes, it is recommended to reach this TIR above 70% of the total measurement time including up to 4% of simultaneous time spent in hypoglycemia. In gestational (and pre-gestational type 2) diabetes, the recommended % of in-range times are not yet specified.

Results of Insulin Therapy in Type 2 Diabetes Mellitus Patients in the Czech Republic: Do They Reflect the Current Status in Other Countries?

The results of two large multicentric, observational and cross-sectional studies (the DIAINFORM study and BALI study) reflecting routine clinical practice for insulin treatment in type 2 diabetes mellitus in the Czech Republic were published recently. In this commentary, we analyze these results and compare them with the findings of similar studies conducted in other countries within the last decade. The analysis focuses on achievement of glycated hemoglobin goals, insulin dosage and frequency of hypoglycemia.

Addition of Basal Insulin to Oral Antidiabetic Agents in Patients with Inadequately Controlled Type 2 Diabetes Leads to Improved HbA1c Levels: Metabolic Control, Frequency of Hypoglycemia, and Insulin Titration Analysis as Results of a Prospective Observational Study (BALI Study).

INTRODUCTION: Despite the continuously growing number of therapeutic options for patients with type 2 diabetes mellitus (T2DM), a large percentage of these individuals fail to achieve their glycated hemoglobin (HbA1c) target. The aim of this study was to determine the change in metabolic control in insulin-naïve T2DM patients inadequately controlled with oral antidiabetic drugs (OADs) at 6 months after initiating basal insulin treatment as add-on to existing OADs. METHODS: This was a non-interventional prospective study conducted from June 2013 to December 2014 in 137 centers in the Czech Republic under routine clinical practice conditions. Adult patients whose diabetes was uncontrolled on their current OAD treatment (HbA1c ≥ 53 mmol/mol; Diabetes Control and Complications Trial [DCCT]-HbA1c 7%) and whose physician had decided to initiate treatment on a basal insulin regimen were documented over a 6-month period beginning from the time of initiation of basal insulin treatment. RESULTS: Overall, 1426 T2DM patients were included in the study, of whom 53% were male. The mean age of the study population was 63.8 ± 10.1 years, mean body mass index was 31.5 ± 5.3 kg/m2, and mean duration of diabetes was 10.2 ± 5.3 years. At the 6-month follow-up, the target HbA1c level of 53 mmol/mol (DCCT < 7%) was achieved by 18% of patients. The mean HbA1c overall had decreased from 77.2 ± 15.1 mmol/mol (DCCT 9.21 ± 1.38%) at baseline to 63.2 ± 12.5 mmol/mol (DCCT 7.93 ± 1.14 %) at the 6-month follow-up. This difference was significant at p < 0.001. The largest mean reduction in HbA1c, i.e., 20.9 mmol/mol (DCCT 2.4 %) was observed in the group of patients with a baseline HbA1c of ≥ 9%. The mean daily basal insulin dose at 6 months was 18.8 ± 8.9 units. Symptomatic hypoglycemia was reported in 12.3% of patients, of those only one patient (0.1%) suffered from severe hypoglycemia. CONCLUSION: The addition of basal insulin to the therapeutic regimen of insulin-naïve T2DM on OAD treatment resulted in an improved metabolic control of diabetes after 6 months of treatment. However, most patients did not achieve their HbA1c target, probably also due to inadequate titration of basal insulin. FUNDING: Sanofi, Czech Republic.

Current Level of Glycemic Control and Clinical Inertia in Subjects Using Insulin for the Treatment of Type 1 and Type 2 Diabetes in the Czech Republic and the Slovak Republic: Results of a Multinational, Multicenter, Observational Survey (DIAINFORM).

INTRODUCTION: The aim of the study was to determine the level of metabolic control in type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) patients in the Czech and Slovak Republics. METHODS: A non-interventional prospective (observational) study was conducted from January 2015 until April 2016 in routine clinical practice settings at 141 centers in the Czech and Slovak Republics. Data were analyzed from a total of 425 patients with T1DM and 1034 patients with T2DM, proportionally corresponding to the number of patients in both countries. The primary objective of the study was to determine the percentage of patients with HbA1c < 7% (53 mmol/mol). RESULTS: Patients with T1DM: In this group of patients (55.8% males, mean age 45.9 ± 14.83 years, BMI 25.8 ± 4.21 kg/m², diabetes duration 12.1 ± 9.44 years), 29.9% reached HbA1c levels < 53 mmol/mol. Patients with T2DM: In this group of patients (50.3% male, mean age 63.9 ± 9.65 years, BMI 31.0 ± 5.19 kg/m², diabetes duration 12.4 ± 7.47 years, duration of insulin therapy 5.8 ± 4.71 years), 33.4% reached HbA1c levels < 53 mmol/mol. CONCLUSION: The overall percentage of patients with HbA1c < 53 mmol/mol in the T1DM group was 29.9% and in the T2DM group was 33.4%. Despite an increasing number of treatment options, most patients still fail to reach the recommended HbA1c targets. FUNDING: Sanofi, Czech Republic.

[Impaired hypoglycemia awareness in diabetes mellitus]. / Syndrom poruseného vnímání hypoglykemie u diabetes mellitus.

UNLABELLED: Impaired hypoglycemia awareness is defined at the onset of neuroglycopenia without the appearance of autonomic warning symptoms. Impaired hypoglycemia awareness is disorder which affects aprox. one third of patients with type 1 diabetes mellitus and 8-10 % of patients with type 2 diabetes mellitus who are treated with insulin. The most dangerous consequence is 6 times higher frequency of severe hypoglycemia in patients with Type 1 diabetes mellitus and 17 times higher in Type 2 diabetic patients treated with insulin. Treatment of impaired hypoglycemia awareness is complex, based on a multifactorial intervention of clinical care and structured patient education. KEY WORDS: diabetes mellitus - hypoglycemia- impaired hypoglycemia awareness.

[Clinical aspects of pharmacological treatment of diabetic neuropathy - cooperation with neurologists and diabetologists]. / Klinické aspekty farmakologické lécby diabetické neuropatie - spolupráce neurologa a diabetologa.

The development and progression of symptomatic diabetic neuropathy (SDN) is linked to hyperglycemia. The effort to improve compensation of diabetes mellitus during therapy is therefore very important. This is where the cooperation between the diabetologist and neurologist within therapy plays an important role. The pharmaco-logical therapy of symptomatic sensitive peripheral diabetic neuropathy is difficult and with a less than satisfactory effect. A variety of active substances is used in symptomatic therapy, primarily designed for intervention in other pathological conditions. The recommended guidelines include antidepressants, anticonvulsants, opiates and their derivatives. However this therapy brings with it a relatively high incidence of adverse effects which detract from patients adherence to treatment. Very good results are reached by the therapy with thioctacid.

[Motor vehicle driving and not only diabetes mellitus - certain aspects of the legislations in the Czech Republic]. / Zdravotní zpusobilost k rízení motorových vozidel a diabetes mellitus - vybrané aspekty z právní úpravy v Ceské republice.

A review of medical fitness to hold a drivers license in diabetes mellitus patients occurs when applying for the license and then at least every three years. Severe hypoglycemic events are an important criterion with the view of eligibility loss to drive a vehicle. All physicians regardless of their speciality who suspect the loss of eligibility in a patient they come into professional contact with are under the obligation to report this fact to the local authority in the patients place of residence.

[Analysis of the development of metformin and sulfonylurea prescriptions in the Czech Republic]. / Analýza vývoje preskripce metforminu a sulfonylurey v Ceské republice.

INTRODUCTION: In the Czech Republic, patients with diabetes mellitus (DM) are followed and treated predominantly by specialists (approx. 80% at a specialist diabetology clinic), a minor part by general practitioners (up to 20%). Long-term development of the changes in prescribing metformin and sulfonylurea in the Czech Republic and its concordance with recommended procedures has not been evaluated until now. GOAL: Comparison of the development of metformin (MET) and sulfonylurea (SU) prescriptions in the period of 2002-2006 with that of 2010-2014 in a representative sample of the patient population with DM kept in the database of the General Health Insurance Company of the Czech Republic (VZP) which provided health care coverage for 63% of Czech Republic population in 2014. METHODOLOGY: We identified all individuals in the VZP database who had a record of DM diagnosis (E10-E16 based on ICD 10) or who had any antidiabetic therapy prescribed (ATC group A10) in the periods of 2002-2006 and 2010-2014. A cohort of patients was extracted for analysis, who had an agent from A10 group prescribed at least once in a relevant year (n=308,962 in 2002; n=426,695 in 2014). A number of patients was evaluated for each year, who had at least once MET or SU prescribed. The number of patients treated with MET or SU was then expressed as a percentage of all who had any therapy from A10 group prescribed in the year in question. RESULTS: Metformin prescriptions have linearly risen from 43% to 77%, while sulfonylurea prescriptions have linearly decreased from 65% to 37%. CONCLUSION: The analysis presents the first evaluation of the development of metformin prescriptions conducted in the Czech Republic and evaluation of its concordance with the recommended procedures for the treatment of DM. The amount of metformin prescribed in the Czech Republic increased from 43% to 77% while the amount of SU prescribed decreased from 65% to 37% between 2002 and 2014. This development and the current ratio between the prescribed amounts of MET and SU demonstrate the implementation of the recommended procedures into practice and prove the high quality of care for patients with DM2T in specialists--diabetologists surgeries.

[Hypolipidemic and antihypertensive therapy in diabetic patients in the Czech Republic: notes on the VZP (General Health Insurance Company) Data]. / Terapie diabetiku hypolipidemiky a antihypertenzivy v Ceské republice: poznámky k datum VZP.

Diabetes mellitus and in particular type 2 diabetes mellitus is one of the most important risk factors of cardiovascular disease. To influence cardiovascular risk there is enormous important not only positive influence of glycemia, but also the treatment of diabetic dyslipidemia and hypertension. The present work provides an analysis of lipid-lowering and antihypertensive therapy for all diabetics registered with General Health Insurance Company in the period 2010-2013. In this time 866,570 patients with diabetes mellitus registered with General Health Insurance Company were treated, the majority of them were diabetics independent on insulin. Approximately half of the patients were observed by dialectologists and half of them by the doctors of other specialization. Out of antihypertensive medi-cation, patients were most often treated by drugs that affect the renin-angiotensin system, as well as beta-blockers and diuretics. Prescription of the lipid-lowering therapy, especially prescription of statins, in accordance with the guidelines, is increasing, but remains insufficient (at 2013 43.6% diabetics treated by dialectologists and 51.3% diabetics treated by GP´s didn´t have lipid lowering therapy). Inadequate use of combination lipid-lowering therapy was recorded too, still represented mainly by combination of statin and fibrate, but in coming years we expect (based on the positive results of the subanalysis IMPROVE-IT study), an increase of combination therapy statin and ezetimibe.

Fear of driving license withdrawal in patients with insulin-treated diabetes mellitus negatively influences their decision to report severe hypoglycemic events to physicians.

BACKGROUND: Under current European Union legislation, two severe hypoglycemic events within 12 months is grounds for driving license withdrawal. The aim of the study reported here was to determine whether fear of such a withdrawal could lead to patients concealing severe hypoglycemia from physicians, which could negatively impact further treatment decisions. METHODS: A total of 663 patients with insulin-treated diabetes were anonymously surveyed about whether they would conceal severe hypoglycemic events from their physicians, if revealing them could result in driving license withdrawal. This investigation utilized an adapted and expanded questionnaire by Graveling et al. RESULTS: Of all diabetic patients surveyed, 26.17% would most likely not report hypoglycemia, and 25.86% were undecided. In a group of patients with type 1 diabetes, 31.83% would likely not report hypoglycemic events, and 25.06% were undecided. The patients least likely to report severe hypoglycemic events were those who indicated that vehicles were partly essential for work, and who also had more than two hypoglycemic events monthly. CONCLUSION: A considerable percentage of diabetic patients would likely conceal severe hypoglycemic events from their physicians due to fear of driving license withdrawal. Patient failure to report severe hypoglycemic events can potentially lead to physicians being misinformed regarding the patient's condition, which could lead to inadequate monitoring and treatment.

Adrenocortical function in young adults with diabetes mellitus type 1.

In 75 young adults with diabetes mellitus type 1 (DM 1) we have performed a cross-sectional study to gain more information about their adrenocortical function. We have found in a surprisingly large portion of patients (25%) a subnormal response (<500 nmol/L, low responders) of the serum cortisol during low-dose Synacthen test, accompanied by significantly decreased stimulated values of aldosterone and salivary cortisol. Basal serum cortisol, aldosterone, and dehydroepiandrosterone sulphate (in women only) were significantly reduced in low responders as well, while ACTH, cortisol binding globulin, plasma renin activity, urinary free cortisol/24h, and salivary cortisol did not differ. The results indicate that the disorder of adrenocortical function in low responders occurs in all adrenocortical zones. The patients with the highest risk in respect to revealed hypocorticalism were DM 1 with autoimmune thyroiditis, 13 out of 36 in contrast to 5 out of 39 suffered from isolated form of DM 1, with onset around 30 years, independently on sex. The biorhythm of salivary cortisol in low responders under real-life conditions did not significantly differ from normal responders, except of the decreased values in the morning. Antibodies against 21-hydroxylase and adrenal cortex were negative in the entire group of diabetics studied. In conclusion, this is the first study to demonstrate in as much as 25% of young adults with DM 1 patients without any signs of adrenal autoimmunity decreased both basal and stimulated serum cortisol and aldosterone levels, implying existence of subclinical primary hypocorticalism.