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МАТЕРИАЛЫ МЕЖДУНАРОДНОЙ НАУЧНО-ПРАКТИЧЕСКОЙ КОНФЕРЕНЦИИ «САХАРНЫЙ ДИАБЕТ - СОВРЕМЕННЫЕ СТАНДАРТЫ ДИАГНОСТИКИ И ЛЕЧЕНИЯ
В РЕСПУБЛИКЕ КАЗАХСТАН - 2014»
УДК 577.175.722:616-08/-053.2
G. ABDUAKHASSOVA1, MD, A. NURBEKOVA2, MD, PHD, I. ASKAROVA3, MD, S. KOSHMAGAMBETOVA4, MD, G. RAKHMATULLINA5, MD, Z. SYZDYKOVA6, MD, M. SERIKBAYEVA, MD7, B. ALIMKHODZHAYEVA8, MD, S. URAZALINA9, MD, N. KONDYBAYEVA10, MD, A. AYAGANOVA11, MD, G. SYZDYKOVA12, MD, R. STANBEKOVA13, MD, I. BURDIKOVA14, MD, B. SAMATOVA15, MD, M. NURMAGANOVA16, MD, G. BAYESSOVA17, MD, T. ZALTSMAN18, MD, S. TRUBACHEVA19, MD, G. YERTUSPAYEVA20, MD, A. IBRAYEVA21, MD, A. DOSKOZHAYEVA21, MD, A. MURATALINA21, MD, PHD, A. SALAHI21, J. B. WELSH2i, MD, PHD, L. YEDIGAROVA21, MD, PHD, F. R. KAUFMAN21 Medical University, Astana Kazakh National Medical University, Almaty City Children's outpatient Clinic #7, Almaty City Children's outpatient Clinic #7, Almaty Medical Center "Zire", Taldy-Korgan Regional endocrinological dispensary, Shymkent Regional endocrinological dispensary, Shymkent Regional Consultative and Diagnostic Medical Center, Taraz Children's outpatient Clinic, Aktau Regional Children's Hospital, Atyrau City Children's outpatient Clinic # 1, Aktobe City policlinic №1, Kokshetau Regional Children's Hospital, Karaganda City Hospital №1, Karaganda Oblast Children's Hospital, Pavlodar Regional Children's Hospital, Kostanay Regional Children's Hospital, Uralsk Regional Children's Hospital, Petropavlovsk Regional Center of Maternity and Childhood, Ust-Kamenogorsk Medical Center of State Medical University, Semey Medtronic, Inc.
_PEDIATRIC INSULIN PUMP THERAPY IN KAZAKHSTAN: AN OBSERVATIONAL STUDY_
Objective: To test the efficacy of continuous subcutaneous insulin infusion (CSII) by measuring glycemic parameters during the first 12 months of a structured, collaborative Industry/Government/Health Care System program that introduced CSII therapy to children in Kazakhstan.
Method: Children 5-15 years of age were offered insulin pump therapy to treat their type 1 diabetes in all 16 regions of the country. Training included insulin pump operation, use of integrated blood glucose (BG) meters, and data uploading to CareLink (Medtronic Diabetes) for retrospective analysis. All study participants visited local pediatric endocrinologists on a quarterly basis for HbA1c determinations, height and weight measurements, CareLink report reviews, and therapy adjustments. Results: As of March 31,2014, 790 children had enrolled with per-site enrollments ranging from 11 to 135. Most children (N=442, 69.6%) had baseline HbAlc values >7.5. In a subgroup of 313 children who completed baseline and 12-month visits, the HbA1c range at 12 months was 4.3% to 14.0%. For those with baseline HbA1c >7.5% (N=221, 70.6%), the mean HbA1c value decreased by 0.85±3.07 percentage points. HbA1c decreased in 63% of patients with baseline HbA1c >7.5 after 12 months of CSII, and 2 3% of these patients had HbA1c values <7.5% at the 12-month visit.
Conclusion: Children adopting CSII in the context of government-industry collaborations, particularly those with poor glycemic control of diabetes, may realize significant glycemic benefits. The Kazakhstan/Medtronic collaboration provides a model for other initiatives that require rapid deployment and/or massive enrollment for introduction of CSII. Keywords: Kazakhstan, type 1 diabetes, children, insulin pump therapy, HbA1c, treatment efficacy.
Background.
Type 1 diabetes mellitus (T1DM) is a disease usually diagnosed in children and young adults. Treatment always requires exogenous insulin administration due to immune-mediated destruction of insulin-producing cells in the pancreas. Worldwide, from 1990 to 2008, the incidence of T1DM has been increasing by 2.8%to 4.0% per year, similar to that observed in the United States and Europe [1, 2]. Despite all achievements in diabetes treatment in the past two decades, T1DM remains a serious cause of mortality and morbidity in youth [3-4]. The primary goals of treatment of T1DM in children and adolescents are maintenance of near-normoglycemia through intensive insulin therapy, avoidance of acute
complications, and prevention of long-term microvascular and macrovascular complications, while facilitating as close to a normal life as possible [5]. The increasing use of insulin pump therapy as a viable alternative to multiple daily injections (MDI) over the last 15 years, particularly in children, is attributable to improvements in pump technology and motivated in part by the results of the Diabetes Control and Complications Trial (DCCT), which established the benefit of improved glycemic control [6, 7]. Ideally, CSII therapy more closely mimics physiological secretion of a healthy pancreas by combining 24-hour continuous adjustable precise "basal" delivery of insulin with prandial-related "boluses" in an effort to eliminate the symptoms and complications of
hyperglycemia, while minimizing the risk of hypoglycemia. Several trials have demonstrated that, when compared to MDI, CSII offers better metabolic control as measured by HbA1c and blood glucose variability, fewer hypoglycemic episodes, and improvements in quality of life [8-11]. Many patients are motivated to consider CSII because of recurrent or severe hypoglycemia, the dawn phenomenon, or poor glycemic control. The possibility of more precisely delivering very small doses of insulin and needle phobia are especially important factors for the pediatric population [12, 13].
Figure 1 shows the insulin pump used in this study and the placement of an optional sensor for continuous glucose monitoring (CGM). The pump contains a reservoir of insulin which is connected to an infusion set. The tip of the cannula of the infusion set is placed in the subcutaneous space and replaced every two to three days. There are significant regional variations in CSII use. In the United States, about 40% of patients with type 1 diabetes use pumps. Pumps are used by >15% of type 1 diabetics in Norway, Austria, Germany, and Sweden, but by <5% of patients in Spain, the UK, Finland, and Portugal [14]. Less than 1% of patients Central and Eastern European countries use this therapy.
A collaborative project, Project Baiterek, between Medtronic Diabetes, the Kazakhstan Ministry of Health, and 16 regional pediatric diabetes clinics began in January, 2012 with the goal of improving the glycemic control and quality of life of children with diabetes by introducing them to CSII therapy [15, 16].To date, Project Baiterek has enrolled over 790 children ages 5-15. Here we present interim results of the study, which is ongoing. Material and Methods.
This is an observational study with retrospective data analysis. Consent for data to be entered into the registry was obtained from all parents or guardians, and data collection was approved by local ethics committees. Paradigm® Veo insulin pumps (Medtronic MiniMed, Inc.), consumables, rapid acting insulin analogs, blood glucose (BG) meters, and a monthly supply of 30 BG test strips were funded by Ministry of Health. Pediatric endocrinologists in each region were identified and attended multiple training sessions supported by Medtronic. Initial two-day long pump therapy training was conducted by two internationally recognized pediatric diabetes experts in Kazakhstan. Advanced training in clinical settings was provided in training centers in Israel, Slovenia, Russia, and USA. Multiple follow-up trainings by industry physicians and educators were conducted in Kazakhstan as well as during international congresses in different locations worldwide. All educational materials for physicians and patients were provided in Russian.
Baseline HbA1c measurements were obtained using various methods in local laboratories; follow-up HbA1c measurements were done on the fully automated, CLIA-waived In2it analyzer (Bio-Rad), calibrated to DCCT-equivalent numbers. All children were to have HbA1c determinations during clinic visits every 3 months; HbA1c values closest to each specified time-point were used for analysis. Patients' demographic characteristics (age, gender, race, diabetes duration, and age of diagnosis) were obtained on the initial visit; height and weight were measured at each clinic visit to calculate body mass index (BMI), in kg/m2. Z scores, which represent the number of standard deviations that observed values deviate from a population mean value, were calculated based on age- and
gender-specific BMI-for-age data from the Centers for Disease Control. Pump and blood glucose data were uploaded to CareLink (Medtronic) for retrospective analysis. Data are presented as mean ± SD. Results.
As of March 31, 2014 790 children had enrolled with persite enrollments ranging from 11 to 135. Figure 2 shows that at enrollment, the mean Z scores for BMI were negative at baseline and at 12 months for both male and female subjects, indicating underweight compared to age-matched controls. Although the mean Z scores at 12 months were still negative, the magnitude of the weight deficit was less than at baseline, suggesting that many children were "catching up" to their peers. Most children (N=442, 69.6%) had baseline HbA1c values >7.5. In a subgroup of 313 children who had completed baseline and 12-month visits, the HbA1c range at 12 months was 4.3% to 14.0% (mean 9.04%±2.12; median 8.5%). For those with baseline HbAlc >7.5% (N=221, 70.6%), the mean HbA1c decreased by 0.85±3.07 percentage points. HbA1c decreased in 63% of patients with baseline HbAlc >7.5 after 12 months of CSII, and 23% of these patients realized HbA1c reductions to less than 7.5%.
Mean daily BG values (averaged over 4 weeks) for this group fell from 12.28±3.99 to 10.45±2.47 mmol/L, a mean 1.83±4.52 (14.9%) mmol/L decrease. HbA1c reduction after 12 months of CSII was more significant in children with shorter diabetes duration. A report from the Kazakhstan Ministry of Health documented decreases in both severe hypoglycemic events and DKA in the children during calendar year 2012.
Separate analysis was done according to age at enrollment to identify age-related trends. Figure 3 shows HbA1c and BG data for males, and Figure 4 shows HbA1c and BG data for females. Baseline HbA1c values were lower in boys than in girls, and the reduction at 12 months was greater in boys than in girls. Reductions in HbA1c and BG from baseline to month 12 were seen in most, but not all, age cohorts. Discussion.
By providing a 24-hour preselected but adjustable basal rate of rapid-acting insulin, along with patient-activated mealtime bolus doses, CSII therapy eliminates the need for periodic injections and provides significant improvements in glycemia, compared to MDI therapy, for many patients with T1DM.
Clinical studies in pediatric populations have shown a significant relationship between HbA1c at commencement of insulin pump therapy and the magnitude of HbA1c improvement. Those who began the pump therapy with an HbA1c of <7.5% had no significant improvement [8].
This is the largest study of insulin pump use in children with fairly long follow-up period conducted in the Central and Eastern Europe. Along with earlier published results on 3- and 6- month follow-ups [15, 16], our data confirm that insulin pump therapy improves glycemic control, with improvements being sustained for at least 12 months. Although this was not a randomized controlled trial, it does reflect 'real life' experience in a large multiethnic population-based sample over a prolonged period and as such provides important information. HbA1c in the cohort of patients with baseline HbA1c greater than 7.5% decreased by 0.85±3.07 percentage points, which correlates with other studies [8, 17-19]. This magnitude of change is clinically significant, as the
DCCT has reported reductions in microvascular complications of 21 to 49% with every 1% reduction in HbA1c [20].
Patients on pump therapy demonstrated significant improvement both in HbA1c and BG level after 12 months of therapy across all age groups regardless of gender, except teenage girls (age 12-15 years old). Adolescent females with T1DM have special concerns that need to be addressed, including psychological distress, typically manifested as anxiety and depression, and a high prevalence of hyperandrogenic conditions [21, 22]. They are also at risk for "diabulimia" in which insulin dosages are manipulated for the purpose of weight loss and which might increase the incidence of serious medical
complications later in life [23]. Teenage girls require special attention and additional training to achieve better glycemic outcomes.
In conclusion, use of modern insulin pump devices for the treatment of T1DM in children and adolescents in Kazakhstan demonstrated high clinical effectiveness with therapy during first year of therapy. Children adopting CSII in the context of government-industry collaborations, particularly those with poor glycemic control and longer duration of diabetes, may realize significant glycemic benefits. The Kazakhstan/Medtronic collaboration provides a model for other initiatives that require rapid deployment and/or massive enrollment for introduction of CSII.
Figure 1 - Typical device placement. The insulin pump is worn at the waist; an optional glucose sensor and transmitter are being worn on the patient's right side. The pump is displaying recent data from the glucose sensor.
Figure 2 - Baseline (filled rectangles) and 12-month (open rectangles) Z scores for body mass index (kg/m2) for male and
female subjects with reported values at both time points
Figure 3 - HbAlc and BG values, male. Shown are the mean baseline (filled rectangles) and 12-month (open rectangles) values for n=102 males with baseline HbAlc >7.5% according to age at enrollment. Panel A, HbAlc; Panel B, blood glucose.
Figure 4 - HbAlc and BG values, female. Shown are the mean baseline (filled rectangles) and 12-month (open rectangles) values for n=119 females with baseline HbAlc >7.5% according to age at enrollment. Panel A, HbAlc; Panel B, blood glucose.
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Г. АБДУАХАСОВА, А. НУРБЕКОВА, И. АСКАРОВА, С. КОШМАГАМБЕТОВА, Г. РАХМАТУЛЛИНА, Ж. СЫЗДЫКОВА, М. СЕРИКБАЕВА, Б. АЛИМХОДЖАЕВА, С. УРАЗАЛИНА, Н. КОНДЫБАЕВА, Г. СЫЗДЫКОВА, Р. СТАНБЕКОВА, И. БУРДИКОВА, Б. САМАТОВА, М. НУРМАГАНОВА, Т. ЗАЛЬЦМАН, С. ТРУБАЧЕВА, Г. ЕРТУСПАЕВА, А. ИБРАЕВА, А. ДОСКОЖАЕВА, А. МУРАТАЛИНА, А. САЛАХИ, ДЖ. УЭЛШ, Л. ЕДИГАРОВА, Ф. КАУФМАН
КАЗАХСТАН РЕСПУБЛИКАСЫНДАFЫ ПЕДИАТРЛЬЩ ПРАКТИКА^Ы ПОМПАЛЫ ИНСУЛИНД1 ТЕРАПИЯ:
КЛИНИКАЛЫЩ БАКЫЛАУ
Тушн: Юр^пе: Осы зерттеудщ ма;саты- инсулиндi Tepi астына узбей енпзу (ИТАYЕ) терапиясын Каза;стандагы педиатрлы; практикага енпзу бойынша ;урылымдалган бipлeскeн жекеменшж-мемлекеттж багдарламанын, аясында 12 ай аралыгында гликемиялы; паpамeтpлepдi елшеу ар;ылы ИТАYЕ тшмдшгш зерттеу. Материалдар мен эдютер: Помпалы инсулиндi терапия елдщ барлы; 16 аймагында кант диабетшщ 1-типш емдеу ушш 5 жастан 15 жас;а дешнп аралы;тагы балаларга усынылган болатын. О;ыту инсулиндi помпа мен бipiктipiлгeн глюкометрдщ пайдаланылуын, сондай-а; ретроспектива талдау журпзу ушш деректердщ CareLink (Медтроник Диабет) багдарламасына ауыстырылуын камтыды. Гликемиялык; гемоглобин децгешн, салмагы мен еамш елшеу ушш, сондай-а; емге тузетулер енпзу ма;сатында CareLink: есебш ;арастыру ушш зерттеу ;атысушыларынын, барлыгы то;сан сайын балалар эндокринологына ;аралып турды.
Нэтижелер: 2014 жылгы 31 наурыздагы деректер бойынша помпалы инсулиндi терапияны 790 бала, онын, шшде ел айма;тарында 11 баладан 135 балага дешн алып жур. Ем алдында балалардыц кепшiлiгiндe (N=442, 69.6%) гликемиялы; гемоглобин дeцгeйi >7.5% болды. Ем басталмай турып, гликемиялы; гемоглобин бойынша дepeктepi болган 313 баладан ;уралган топта терапия ЖYpгiзiлiп отырган 12 айдан сон, HbA1c дeцгeйi 4.3% бастап, 14.0% дешнп аралы;та болган. Базальдi мэндepi >7.5% (N=221, 70.6%) балаларда гликемиялы; гeмоглобиннiн орташа децгеш 0.85±3.07пайызды; тарма;;а темендеген. Базальдi мэндepi >7.5% пациeнттepдiн 63% гликемиялы; гемоглобин 12 ай бойы ЖYpгiзiлгeн терапиядан кешн темендеп, олардын 23% HbA1c дeнгeйi 7.5% темен болды. Тужырым: Жeкeмeншiк-мeмлeкeттiк сepiктeстiк шeнбepiндe помпалы инсулиндi терапия ;абылдайтын балаларды eмдeудiн нэтижеа, эсipeсe, гликемиялы; ба;ылауы ай;ын кертсте бузылган балалар тобында жогары. Каза;стан Республикасынын Денсаулы; са;тау министpлiгi мен Медтроник компаниясы арасындагы ынтыма;тасты; денсаулы; саласындагы багдарламалар Yшiн помпалы инсулиндi терапиянын тез арада ете алып, жаппай енпзшуш талап eтeтiн бipeгeй Yлгi болып табылады.
ТYЙiндi сездер: Каза;стан, ;ант диабeтiнiн 1-типi, балалар, помпалы инсулиндi терапия, гликемиялы; гемоглобин, шипанын, тиiмдiлiгi
Г. АБДУАХАСОВА, А. НУРБЕКОВА, И. АСКАРОВА, С. КОШМАГАМБЕТОВА, Г. РАХМАТУЛЛИНА, Ж. СЫЗДЫКОВА, М. СЕРИКБАЕВА, Б. АЛИМХОДЖАЕВА, С. УРАЗАЛИНА, Н. КОНДЫБАЕВА, Г. СЫЗДЫКОВА, Р. СТАНБЕКОВА, И. БУРДИКОВА, Б. САМАТОВА, М. НУРМАГАНОВА, Т. ЗАЛЬЦМАН, С. ТРУБАЧЕВА, Г. ЕРТУСПАЕВА, А. ИБРАЕВА, А.
ДОСКОЖАЕВА,
А. МУРАТАЛИНА, А. САЛАХИ, ДЖ. УЭЛШ, Л. ЕДИГАРОВА, Ф. КАУФМАН
ПОМПОВАЯ ИНСУЛИНОТЕРАПИЯ В ПЕДИАТРИЧЕСКОЙ ПРАКТИКЕ В РЕСПУБЛИКЕ КАЗАХСТАН:
КЛИНИЧЕСКОЕ НАБЛЮДЕНИЕ
Резюме: Введение: Целью данного исследования является изучение эффективности непрерывного подкожного введения инсулина (НПВИ) путем измерения гликемических параметров в течение 12 месяцев в рамках структурированной совместной частно-государственной программы по внедрению НПВИ терапии в педиатрическую практику в Казахстане.
Материалы и методы: Помповая инсулинотерапия была предложена детям в возрасте от 5 до 15 лет для лечения 1 типа сахарного диабета во всех 16 регионах страны. Обучение включало использование инсулиновой помпы и интегрированного глюкометра, а также переброску данных на программу СагеЫпк (Медтроник Диабет) для ретроспективного анализа. Все участники исследования ежеквартально посещали детского эндокринолога для измерения уровня гликированного гемоглобина, веса и роста, а также для рассмотрения отчета СагеЫпк с целью коррекции лечения.
Результаты: По данным на 31 марта 2014 года 790 детей находятся на помповой инсулинотерапии, с распределением по регионам от 11 до 135 пациентов. У большинства детей (N=442, 69.6%) до начала лечения уровень гликированного гемоглобина был >7.5%. В группе из 313 детей, имевших данные по гликированному гемоглобину до лечения, через 12 месяцев терапии уровень НЬА1с колебался от 4.3% до 14.0%. Средний уровень гликированного гемоглобина у детей с базальными значениями >7.5% (N=221, 70.6%) снизился на 0.85±3.07 процентных пункта. Гликированный гемоглобин снизился у 63% пациентов с базальными значениями >7.5% после 12 месяцев терапии, причем у 23% из них уровень НЬА1с опустился ниже 7.5%.
Выводы: Лечение детей, находящиеся на помповой инсулинотерапии в рамках частно-государственного партнерства, является высокоэффективным, особенно в группе детей с выраженным нарушением гликемического контроля. Сотрудничество между Министерством Здравоохранения Республики Казахстан и компанией Медтроник представляет собой уникальный образец для программ в сфере здравоохранения, требующих быстрого развертывания и массового внедрения помповой инсулинотерапии.
Ключевые слова: Казахстан, диабет 1 типа, дети, помповая инсулинотерапия, гликированный гемоглобин, эффективность лечения.
УДК 612.014-616.379-008.64/-053.2/-07
А.А. НУРБЕКОВА, З.С. ЖАПАРХАНОВА, А.О. СМАГУЛ Казахский Национальный медицинский университет им. С.Д.Асфендиярова
РОЛЬ МОЛЕКУЛЯРНО - ГЕНЕТИЧЕСКОГО АНАЛИЗА ДЕФЕКТОВ БЕТА - КЛЕТОЧНОЙ ФУНКЦИИ В _ДИАГНОСТИКЕ САХАРНОГО ДИАБЕТА У ДЕТЕЙ_
Дефекты гена КС]М11, кодирующего Шг6.2 субъединицу калиевого канала, является наиболее частой причиной диабета, развивающегося до 6-месячного возраста. Гетерозиготная миссенс мутация в гене КСИ]11 вызывает нарушение биосинтеза инсулина и манифестацию СД в течение первых недель жизни ребенка. Впервые в Казахстане проведено молекулярно-генетическое исследование и описание 2 случаев неонатального СД. Показана роль молекулярно-генетического анализа дефектов бета-клеточной функции в дифференциальной диагностике сахарного диабета у детей первого года жизни.
Ключевые слова: неонатальный сахарный диабет, мутация в гене калиевого канала.
Сахарный диабет (СД) у детей первого года жизни представлен гетерогенной группой заболеваний, включающей как СД 1 типа в результате аутоиммунного поражения поджелудочной железы, так и ряд моногенных форм, ассоциированных с мутациями в генах, обеспечивающих нормальное развитие и функцию панкреатических бета-клеток. К моногенным заболеваниям относят болезни, вызванные мутацией единственного гена. Согласно этиологической классификации СД (ВОЗ, 1999) моногенные формы СД относят к группе специфических типов диабета, связанных с генетическими дефектами в-клеточной функции и
включают диабет типа MODY и неонатальный СД (НСД) [1,2].
Для неонатального СД характерно изолированное нарушение глюкозостимулироованной секреции инсулина (мутации в генах KCNJ11, ABCC8, GCK, INS) [3-5]. В ряде случаев СД, дебютировавший на первом году жизни ребенка, является частью таких синдромов как синдром Дауна, Клайнфельтера, Тернера, Вольфрама, Лоуренса-Муна-Барде-Бидля, Прадера-Вилли [1].
Выделяют две формы заболевания - транзиторный неонатальный диабет (ТНСД) и перманентный неонатальный СД (ПНСД). При дифференциальном
