Alleviating carbohydrate counting with a FiASP-plus-pramlintide closed-loop delivery system (artificial pancreas): Feasibility and pilot studies.

AIM: To assess whether a FiASP-and-pramlintide closed-loop system has the potential to replace carbohydrate counting with a simple meal announcement (SMA) strategy (meal priming bolus without carbohydrate counting) without degrading glycaemic control compared with a FiASP closed-loop system. MATERIALS AND METHODS: We conducted a 24-hour feasibility study comparing a FiASP system with full carbohydrate counting (FCC) with a FiASP-and-pramlintide system with SMA. We conducted a subsequent 12-day outpatient pilot study comparing a FiASP-and-placebo system with FCC, a FiASP-and-pramlintide system with SMA, and a FiASP-and-placebo system with SMA. Basal-bolus FiASP-and-pramlintide were delivered at a fixed ratio (1 U:10 µg). Glycaemic outcomes were measured, surveys evaluated gastrointestinal symptoms and diabetes distress, and participant interviews helped establish a preliminary coding framework to assess user experience. RESULTS: Seven participants were included in the feasibility analysis. Time spent in 3.9-10 mmol/L was similar between both interventions (81%-84%). Four participants were included in the pilot analysis. Time spent in 3.9-10 mmol/L was similar between the FiASP-and-placebo with FCC and FiASP-and-pramlintide with SMA interventions (70%), but was lower in the FiASP-and-placebo with SMA intervention (60%). Time less than 3.9 mmol/L and gastrointestinal symptoms were similar across all interventions. Emotional distress was moderate at baseline, after the FiASP-and-placebo with FCC and SMA interventions, and fell after the FiASP-and-pramlintide with SMA intervention. SMA reportedly afforded participants flexibility and reduced mealtime concerns. CONCLUSIONS: The FiASP-and-pramlintide system has the potential to substitute carbohydrate counting with SMA without degrading glucose control.

From toy to tool: Using water beads for insulin storage in Haiti.

Diabetes prevalence within the global population has nearly doubled since 1980, with the most rapid growth occurring in low- and middle-income countries. Diabetes management in resource-limited settings such as Haiti presents many challenges, including the storage of insulin. Despite a lack of published data on insulin thermostability, storage at 2-8°C or at room temperature (25°C) is recommended. In Haiti, access to refrigeration and thereby proper insulin storage is severely limited. Commercial storage devices such as the FRIO cooling wallet are cost-prohibitive and not available locally, and alternatives such as small clay pots are fragile and nonportable. Here, we designed and tested the cooling efficacy of a homemade wallet made of acrylate polymer beads and a hand-sewn cotton pouch compared to a FRIO wallet and a clay pot. All studies were conducted over a ten-day period at the Kay Mackenson Clinic in Montrouis, Haiti. Temperature and humidity values were continuously collected using wireless monitors placed inside each device, and hourly ambient temperature and humidity values were manually recorded. Evaporative cooling efficacy was calculated using collected data. The homemade wallet and FRIO cooling wallet demonstrated comparable cooling efficacy with an average of 71% and 73%, respectively. The clay pot demonstrated significantly decreased efficacy with an average of 27% (p < 0.05). The homemade insulin wallet is a promising alternative for the storage of insulin in low-resource settings without the financial and physical barriers of commercial and locally sourced devices. Additionally, this wallet could be readily adapted for the storage of other perishable medical supplies in low-income countries.

Postprandial hyperglycaemia following insulin suspensions by the artificial pancreas: Implications for bolus calculators.

Conventional bolus calculators apply negative prandial corrections when premeal glucose levels are low. However, no study has evaluated the need for this negative correction with closed-loop systems. We analysed data retrospectively from a cohort study evaluating a closed-loop artificial pancreas system conducted in a diabetes camp over a period of 11 days. Meal boluses with negative correction (n = 98) of 47 participants aged 8 to 22 years were examined. If there was no insulin-on-board from previous boluses at mealtime, the postprandial hyperglycaemia rate increased with increased duration of insulin suspension (P = .03), with odds ratios being exaggerated by 17% per 10 minutes of suspension. However, if there was insulin-on-board from previous boluses, the hyperglycaemia rate did not change with increased duration of insulin suspension (P = .24). When there was no insulin-on-board, the rate of hyperglycaemia after meals preceded by no suspension was 21% (3/14), compared with 52% (12/23) and 64% (9/14) after meals preceded by suspensions of ≥50 and ≥70 minutes, respectively. Meal size did not influence these results. We conclude that, in the absence of insulin-on-board, negative prandial corrections may not be necessary following long insulin suspensions.

A pilot non-inferiority randomized controlled trial to assess automatic adjustments of insulin doses in adolescents with type 1 diabetes on multiple daily injections therapy.

BACKGROUND: Multiple daily injections (MDI) therapy for type 1 diabetes involves basal and bolus insulin doses. Non-optimal insulin doses contribute to the lack of satisfactory glycemic control. We aimed to evaluate the feasibility of an algorithm that optimizes daily basal and bolus doses using glucose monitoring systems for MDI therapy users. METHODS: We performed a pilot, non-inferiority, randomized, parallel study at a diabetes camp comparing basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA), in children and adolescents on MDI therapy. Participants wore a glucose sensor and underwent 11 days of daily dose adjustments in either arm. Algorithm adjustments were reviewed and approved by a physician. The last 7 days were examined for outcomes. RESULTS: Twenty-one youths (age 13.3 [SD, 3.7] years; 13 females; HbA1c 8.6% [SD, 1.8]) were randomized to either group (LA [n = 10] or PA [n = 11]). The algorithm made 293 adjustments with a 92% acceptance rate from the camp physicians. In the last 7 days, the time in target glucose (3.9-10 mmol/L) in LA (39.5%, SD, 20.7) was similar to PA (38.4%, SD, 15.6) (P = .89). The number of hypoglycemic events per day in LA (0.3, IQR, [0.1-0.6]) was similar to PA (0.2, IQR, [0.0-0.4]) (P = .42). There was no incidence of severe hypoglycemia nor ketoacidosis. CONCLUSIONS: In this pilot study, glycemic outcomes in the LA group were similar to the PA group. This algorithm has the potential to facilitate MDI therapy, and longer and larger studies are warranted.

A new imaging entity consistent with partial ectopic posterior pituitary gland: report of six cases.

BACKGROUND: Abnormal posterior pituitary development including ectopic location has been associated with endocrine manifestations of anterior pituitary dysfunction. OBJECTIVE: We describe an unreported clinical and radiologic entity we call partial ectopic posterior pituitary for which associated endocrine consequences are not known. MATERIALS AND METHODS: We selected pediatric head MRI examinations from 2005 to 2017 based on the finding of a double midline sellar and suprasellar bright spot on T1-weighted sequence. Medical history, physical examination, pituitary hormonal profile and bone age evaluation were extracted from the medical record of the selected patients. An experienced pediatric neuroradiologist reviewed head MRIs, which were performed on 3-tesla (T) magnet and included at least sagittal T1-weighted imaging centered on the sella turcica obtained with and without fat suppression. RESULTS: In six cases, two midline bright spots were identified on T1-weighted sequences obtained both with and without fat suppression. While one spot was located at the expected site of the neurohypophysis in the posterior sella, the second one was in the region of the median eminence, suggesting partial ectopic posterior pituitary gland. Growth hormone deficiency, either isolated (n=1) or combined with thyroid stimulating hormone deficiency (n=1) was found. None of the children had clinical signs of posterior pituitary dysfunction. CONCLUSION: We describe an unreported imaging entity suggesting partial ectopic posterior pituitary gland in six children. Anterior pituitary hormone deficiencies might be detected in those children and long-term follow-up could provide additional information on the development of other pituitary hormone deficiencies.

Normal weight metabolically unhealthy phenotype in youth: Do definitions matter?

BACKGROUND: Normal weight metabolically unhealthy (NWMU) adults are at increased risk of cardiometabolic disease, however, little is known regarding NWMU children. OBJECTIVES: We examined the associations between existing definitions of NWMU in children aged 8 to 10 years and insulin sensitivity (IS) and secretion 2 years later. METHODS: Data stem from the Quebec Adipose and Lifestyle InvesTigation in Youth (QUALITY) cohort of 630 Caucasian youth, 8 to 10 years old at baseline, with at least one obese biological parent. Of these, 322 normal weight children were classified as NWMU using four definitions. At 10 to 12 years, IS was measured with the Matsuda-insulin sensitivity index; insulin secretion was measured with the ratio of the area under the curve (AUC) of insulin to the AUC of glucose over a 2-hour oral glucose tolerance test. Multiple linear regression models were used. RESULTS: Because few children met the existing definitions of metabolic syndrome, associations were examined for less stringent definitions (eg, having two vs no risk factors). At baseline, IS was lower in NWMU children compared to children with no risk factors (virtually all definitions). Moreover, after 2 years, IS was 14.4-19.3% lower in NWMU children with one or more risk factors, and up to 29.7% lower in those with two or more risk factors compared to those with none. Insulin secretion was not predicted by components of the metabolic syndrome. CONCLUSION: Existing definitions of NWMU youth performed relatively similarly in predicting IS as youth entered puberty. Children with one or more components of metabolic syndrome-even when of normal weight-have significantly lower IS over time.

Levels of type 1 diabetes care in children and adolescents for countries at varying resource levels.

Optimal care for children and adolescents with type 1 diabetes is well described in guidelines, such as those of the International Society for Pediatric and Adolescent Diabetes. High-income countries can usually provide this, but the cost of this care is generally prohibitive for lower-income countries. Indeed, in most of these countries, very little care is provided by government health systems, resulting in high mortality, and high complications rates in those who do survive. As lower-income countries work toward establishing guidelines-based care, it is helpful to describe the levels of care that are potentially affordable, cost-effective, and result in substantially improved clinical outcomes. We have developed a levels of care concept with three tiers: "minimal care," "intermediate care," and "comprehensive (guidelines-based) care." Each tier contains levels, which describe insulin and blood glucose monitoring regimens, requirements for hemoglobin A1c (HbA1c) testing, complications screening, diabetes education, and multidisciplinary care. The literature provides various examples at each tier, including from countries where the life for a child and the changing diabetes in children programs have assisted local diabetes centres to introduce intermediate care. Intra-clinic mean HbA1c levels range from 12.0% to 14.0% (108-130 mmol/mol) for the most basic level of minimal care, 8.0% to 9.5% (64-80 mmol/mol) for intermediate care, and 6.9% to 8.5% (52-69 mmol/mol) for comprehensive care. Countries with sufficient resources should provide comprehensive care, working to ensure that it is accessible by all in need, and that resulting HbA1c levels correspond with international recommendations. All other countries should provide Intermediate care, while working toward the provision of comprehensive care.

Capacity Building and Innovation in Caring for Non-communicable Diseases in Maternal Global Health: The Example of Haiti.

Non-communicable diseases (NCDs) are important contributors to maternal morbidity and mortality worldwide. Yet, data on their prevalence and related outcomes in low-income countries are currently lacking. Additionally, screening and treatment protocols adapted for resource-limited settings are urgently required. This collaborative research initiative on the screening and management of hypertensive disorders of pregnancy and gestational diabetes was conducted in Saint-Nicolas Hospital in Saint-Marc, Haiti. The report discusses methods used to overcome several local challenges to implementation of care for NCDs. It also describes how collaborative research initiatives are efficient strategies to innovate and build research capacity for NCD care delivery during pregnancy in low-income countries.

High rates of ocular complications in a cohort of Haitian children and adolescents with diabetes.

BACKGROUND: Ophthalmic complications of pediatric diabetes are rare, and rates are unknown in Haitian youth. OBJECTIVES: To determine the prevalence and predictors of diabetic retinopathy (DR) and cataracts in a cohort of Haitian youth with insulin-treated diabetes. METHODS: We performed a cross-sectional retrospective review of pediatric patients with diabetes from a pediatric chronic disease center in Haiti, from December 1, 2012 to November 1, 2016. Data collection included demographic and anthropometric information, total daily insulin dose and result of eye examination by a local ophthalmologist. RESULTS: Of 67 patients (54% female, mean age at diagnosis 14.6 ± 3.9 years, mean diabetes duration 3.3 ± 3.0 years, mean HbA1c 84 ± 22 mmol/mol (9.8% ± 2.0%), mean current insulin requirement 0.49 ± 0.28 IU/kg/day), DR was diagnosed in 10/57 (18%) and cataracts in 10/62 (16%), at a mean age of 19.0 ± 4.3 and 19.1 ± 3.3 years, respectively. Diabetes duration was 4.9 ± 5.4 and 3.0 ± 1.5 years at the time of diagnosis of DR and cataracts, respectively. Age at complication, insulin requirement, sex, body mass index, family history, mean HbA1c and diabetes duration were not significant predictors of an ocular complication. CONCLUSIONS: In this cohort of Haitian youth, DR and cataracts occur prematurely. Low-insulin requirements years after diagnosis, possibly allowing for prolonged undetected hyperglycemia prediagnosis, may explain complication risk. The phenotypes of diabetes in pediatric populations of African ancestry may be distinct. Ophthalmologic evaluation should possibly start at diagnosis, and screening guidelines may need to be adapted.

Utility of diabetes-associated autoantibodies for classification of new onset diabetes in children and adolescents.

OBJECTIVE: To determine whether measuring diabetes-associated autoantibodies (DAA) in pediatric new onset diabetes (NODM) can be restricted to patients with equivocal diabetes type. RESEARCH DESIGN AND METHODS: Retrospective analysis of all patients with NODM admitted to Boston Children's Hospital from 1 October 2007 to 1 July 2013 who had measurement of DAA [glutamic acid decarboxylase, insulin, insulinoma-associated antigen 2 (IA-2)]. Data collection included initial diagnosis of diabetes type before DAA results and at follow-up. We used logistic regression to predict type 1 diabetes (T1D) and developed a clinical score to classify diabetes type. RESULTS: Of 1089 patients (45.4% female, 76.7% White, age 10.6 ± 4.5 yr), initial diagnosis was 1021 (93.8%) T1D, 42 (3.9%) type 2 diabetes (T2D), and 26 (2.4%) other. Of 993 patients with clinical T1D, 78 (7.9%) were DAA-, and of 42 patients with clinical T2D, 12 (28.6%) were DAA+. Type of diabetes was reclassified at follow-up in less than 6% of patients. Data from a subset of 736 patients were used to develop a scoring system to predict T1D. Using weight z-score, age, and race, the scoring system had 91.7% sensitivity, 82% specificity, and a positive predictive value of 98.6%, and suggested DAA measurement was unnecessary in 85.3% of patients. Findings were similar in a validation cohort of 234 patients. CONCLUSIONS: Application of a simple scoring system may reduce to ∼15% the number of DAA measurements needed to classify diabetes type, resulting in substantial cost savings. Clinical judgment should guide the decision to measure DAA.

Skeletal dysplasia, global developmental delay, and multiple congenital anomalies in a 5-year-old boy-report of the second family with B3GAT3 mutation and expansion of the phenotype.

As a major component of the extracellular matrix, proteoglycans influence the mechanical properties of connective tissue and play an important role in cell-cell and cell-matrix interactions. Genetic defects of proteoglycan biosynthesis lead to multi-system disorders, often most prominently affecting the skeletal system and skin. Specific deficiencies in the enzymes involved in the biosynthesis of the linkage region between the core of the proteoglycan protein and its glycosaminoglycan side chains are known as linkeropathies. We report on a patient from a second family with a homozygous c.830G>A (p.Arg277Gln) mutation in the B3GAT3 gene. The clinical features expand the previously reported phenotype of B3GAT3 mutations and of linkeropathies in general. This patient has short stature, facial dysmorphisms, skeletal findings, joint laxity, and cardiac manifestations similar to those previously associated with B3GAT3 mutations. However, he also has developmental delay, a refractive errors, dental defects, pectus carinatum, and skin abnormalities that have only been associated with linkeropathies caused by mutations in B4GALT6 and B4GALT7. He has bilateral inguinal hernias and atlanto-axial as well as atlanto-occipital instability that have not been previously associated with B3GAT3 mutations. We provide a detailed clinical report and a comparative overview of the phenotypic features of the linkeropathies caused by mutations in B3GAT3, B4GALT6, and B4GALT7.

Type 1 diabetes care delivery in Yaoundé, Cameroon: Social and political representations.

BACKGROUND:  Increasing chronic diseases challenges the health systems of low- and middle-income countries, including Cameroon. Type 1 diabetes (T1D), among the most common chronic diseases in children, poses particular care delivery challenges. AIM:  We examined social representations of patients' roles and implementation of T1D care among political decision-makers, healthcare providers and patients within families. SETTING:  The study was conducted in Yaoundé, Cameroon. METHODS:  Eighty-two individuals were included in the study. The authors conducted semi-structured interviews with policy makers (n = 5), healthcare professionals (n = 7) and patients 'parents (n = 20). Questionnaires were administered to paediatric patients with T1D (n = 50). The authors also observed care delivery at a referral hospital and at a T1D-focused non-governmental organisation over 15 days. Data were analysed using thematic content analysis and descriptive statistics. RESULTS:  Cameroonian health policy portrays patients with T1D as passive recipients of care. While many practitioners recognised the complex social and economic determinants of adherence to T1D care, in practice interactions focused on specific biomedical issues and offered brief guidance. Cultural barriers and policy implementation challenges prevent patients and their families from being fully active participants in care. Parents and children prefer an ongoing relationship with a single clinician and interactions with other patients and families. CONCLUSION:  Patients and families mobilise experience and lay knowledge to complement biomedical knowledge, but top-down policy and clinical practice limit their active engagement in T1D care.Contribution: Children with T1D and their families, policy makers, healthcare professionals, and civil society have new opportunities to contribute to person-centred care, as advocated by the Sustainable Development Goals.

Simple meal announcements and pramlintide delivery versus carbohydrate counting in type 1 diabetes with automated fast-acting insulin aspart delivery: a randomised crossover trial in Montreal, Canada.

BACKGROUND: In type 1 diabetes, carbohydrate counting is the standard of care to determine prandial insulin needs, but it can negatively affect quality of life. We developed a novel insulin-and-pramlintide closed-loop system that replaces carbohydrate counting with simple meal announcements. METHODS: We performed a randomised crossover trial assessing 14 days of (1) insulin-and-pramlintide closed-loop system with simple meal announcements, (2) insulin-and-placebo closed-loop system with carbohydrate counting, and (3) insulin-and-placebo closed-loop system with simple meal announcements. Participants were recruited at McGill University Health Centre (Montreal, QC, Canada). Eligible participants were adults (aged ≥18 years) and adolescents (aged 12-17 years) with type 1 diabetes for at least 1 year. Participants were randomly assigned in a 1:1:1:1:1:1 ratio to a sequence of the three interventions, with faster insulin aspart used in all interventions. Each intervention was separated by a 14-45-day wash-out period, during which participants reverted to their usual insulin. During simple meal announcement interventions, participants triggered a prandial bolus at mealtimes based on a programmed fixed meal size, whereas during carbohydrate counting interventions, participants manually entered the carbohydrate content of the meal and an algorithm calculated the prandial bolus based on insulin-to-carbohydrate ratio. Two primary comparisons were predefined: the percentage of time in range (glucose 3·9-10·0 mmol/L) with a non-inferiority margin of 6·25% (non-inferiority comparison); and the mean Emotional Burden subscale score of the Diabetes Distress Scale (superiority comparison), comparing the insulin-and-placebo system with carbohydrate counting minus the insulin-and-pramlintide system with simple meal announcements. Analyses were performed on a modified intention-to-treat basis, excluding participants who did not complete all interventions. Serious adverse events were assessed in all participants. This trial is registered on ClinicalTrials.gov, NCT04163874. FINDINGS: 32 participants were enrolled between Feb 14, 2020, and Oct 5, 2021; two participants withdrew before study completion. 30 participants were analysed, including 15 adults (nine female, mean age 39·4 years [SD 13·8]) and 15 adolescents (eight female, mean age 15·7 years [1·3]). Non-inferiority of the insulin-and-pramlintide system with simple meal announcements relative to the insulin-and-placebo system with carbohydrate counting was reached (difference -5% [95% CI -9·0 to -0·7], non-inferiority p<0·0001). No statistically significant difference was found in the mean Emotional Burden score between the insulin-and-pramlintide system with simple meal announcements and the insulin-and-placebo system with carbohydrate counting (difference 0·01 [SD 0·82], p=0·93). With the insulin-and-pramlintide system with simple meal announcements, 14 (47%) participants reported mild gastrointestinal symptoms and two (7%) reported moderate symptoms, compared with two (7%) participants reporting mild gastrointestinal symptoms on the insulin-and-placebo system with carbohydrate counting. No serious adverse events occurred. INTERPRETATION: The insulin-and-pramlintide system with simple meal announcements alleviated carbohydrate counting without degrading glucose control, although quality of life as measured by the Emotional Burden score was not improved. Longer and larger studies with this novel approach are warranted. FUNDING: Juvenile Diabetes Research Foundation.

Incremental Progress in Pharmacotherapy for Pediatric Type 2 Diabetes.

Type 2 diabetes is no longer an adult-only disease but, sadly, has become an established entity in youth. Globally, an estimated 41,600 youth are newly diagnosed every year.1 Underrepresented groups, migrants, and youth of lower socioeconomic status are disproportionately affected. While incidence rates are rising steeply in almost all populations, annual increases in several non-White racial populations now surpass those of type 1 diabetes.1.

Socioeconomic Disparities in Glycemic Management in Children and Youth With Type 1 Diabetes: A Retrospective Cohort Study.

OBJECTIVE: In Canada, few studies have addressed health inequalities in type 1 diabetes (T1D) outcomes. In this study, we examined the relationship between socioeconomic status (SES) and glycemic management in children with T1D and determine whether technology use (insulin pumps or continuous glucose monitoring [CGM]), diabetes-related physician visits, and depressive symptoms modified the association. METHODS: This work was a retrospective cohort study using the Montréal Children's Hospital Pediatric Diabetes Database of children 0 to 18 years old, diagnosed with T1D for ≥1 year, and with a hospital visit between November 2019 and October 2020. Main exposure was SES measured by the Material and Social Deprivation Index (least, moderately, or most deprived). We determined the association between SES and mean glycated hemoglobin (A1C; main outcome) in the year after the index visit using multivariable linear regression, adjusting for age, sex, diabetes duration, technology use, diabetes-related physician visits, and depressive symptoms (subgroup). We examined interaction terms for technology use, diabetes-related physician visits, and depressive symptoms. RESULTS: The study cohort included 306 children (mean age 13.6 years, mean A1C 8.5%). Children in the most-deprived compared with least-deprived quintiles had higher mean A1C; effect modification was significant with CGM only. Children not using CGM in the most-deprived compared with least-deprived quintiles had higher mean A1C (0.52%; 95% confidence interval, 0.14% to 0.86%), whereas the association was not significant for children using CGM. CONCLUSIONS: Lower SES was associated with higher A1C; these disparities were not observed among CGM users. Further research is required to determine strategies to promote CGM access among children of lower SES in the Canadian health-care context.

Epidemiology and phenotypes of diabetes in children and adolescents in non-European-origin populations in or from Western Pacific region.

BACKGROUND: Type 1 diabetes (T1D) incidence varies substantially between countries/ territories, with most studies indicating increasing incidence. In Western Pacific region (WPR), reported rates are much lower than European-origin populations. In contrast, there are reports of substantial numbers of young people with type 2 diabetes (T2D). A deeper understanding of T1D and T2D in the WPR may illuminate factors important in pathogenesis of these conditions. Furthermore, with varying resources and funding for diabetes treatment in this region, there is a need to more clearly determine the current burden of disease and also any gaps in knowledge. AIM: To compile and summarise published epidemiologic and phenotypic data on childhood diabetes in non-European populations in and from WPR. METHODS: Research articles were systematically searched from PubMed (MEDLINE), Embase, Cochrane library, and gray literature. Primary outcome measures were incidence and prevalence, with secondary measures including phenotypic descriptions of diabetes, including diabetes type categorization, presence of diabetic ketoacidosis (DKA) at onset, autoantibody positivity, C-peptide levels, and human leucocyte antigen phenotype. Extracted data were collected using a customized template. Three hundred and thirty relevant records were identified from 16 countries/territories, with analysis conducted on 265 (80.3%) records published from the year 2000. RESULTS: T1D incidence ranged from < 1-7.3/100000 individuals/year, rates were highest in emigrant/ mixed populations and lowest in South-East Asia, with most countries/territories (71.4%) having no data since 1999. Incidence was increasing in all six countries/territories with data (annual increases 0.5%-14.2%, highest in China). Peak age-of-onset was 10-14 years, with a female case excess. Rate of DKA at onset varied from 19.3%-70%. Pancreatic autoantibodies at diagnosis were similar to European-origin populations, with glutamic acid decarboxylase-65 autoantibody frequency of 44.1%-64.5%, insulinoma-associated 2 autoantibody 43.5%-70.7%, and zinc transporter-8 autoantibody frequency 54.3% (one study). Fulminant T1D also occurs. T2D was not uncommon, with incidence in Japan and one Chinese study exceeding T1D rates. Monogenic forms also occurred in a number of countries. CONCLUSION: T1D is less common, but generally has a classic phenotype. Some countries/ territories have rapidly increasing incidence. T2D is relatively common. Registries and studies are needed to fill many information gaps.

Validation Study and Outcomes of the Diabetes Quality of Life in Youth Instrument in Haitian Youth With Type 1 Diabetes Residing in Haiti.

OBJECTIVES: Health-related quality of life (HRQL) in type 1 diabetes is a critical health outcome but has not been studied in many low-income countries. In this study we evaluated the validity of 2 HRQL instruments, measured the HRQL and explored the association between HRQL and glycemic control. METHODS: This was a cross-sectional study of Haitian youth with diabetes between 0 and 25 years of age and living in Haiti. We administered the 51-item Diabetes Quality of Life for Youth (DQOLY) questionnaire and the EuroQol Visual Analogue Scale (EQ-VAS). Psychometric analyses evaluated internal consistency and construct validity of the DQOLY and its 21-item short form, the DQOLY-SF. Linear regression was used to identify predictors of HRQL and glycated hemoglobin (A1C). RESULTS: In 85 youth (59% female; mean age, 17.5 years; mean diabetes duration, 3.7 years; mean A1C, 11.3%), DQOLY and DQOLY-SF had adequate internal consistency with Cronbach's alpha values of 0.86 and 0.84, respectively. Confirmatory factor analysis revealed adequate validity for the DQOLY-SF and DQOLY Satisfaction subscale. HRQL, as measured using the DQOLY-SF, was 62±16 (mean ± standard deviation) out of 100. Mean EQ-VAS score was 78±24 out of 100. Older age (p=0.004), female sex (p=0.02) and lower socioeconomic status (SES) (p=0.03) were risk factors for lower DQOLY score, and older age (p=0.02) and marginally female sex (p=0.06) for lower DQOLY-SF score. No predictors of EQ-VAS were identified. HRQL measures were not associated with glycemic control. CONCLUSIONS: The DQOLY-SF and DQOLY Satisfaction subscale are valid measures of HRQL in Haitian youth with diabetes. HRQL is low and was worse in older, female and low-SES youth, but was not associated with glycemic control.

A Meal Detection Algorithm for the Artificial Pancreas: A Randomized Controlled Clinical Trial in Adolescents With Type 1 Diabetes.

OBJECTIVE: We developed a meal detection algorithm for the artificial pancreas (AP+MDA) that detects unannounced meals and delivers automatic insulin boluses. RESEARCH DESIGN AND METHODS: We conducted a randomized crossover trial in 11 adolescents aged 12-18 years with HbA1c ≥7.5% who missed one or more boluses in the past 6 months. We compared 1) continuous subcutaneous insulin infusion (CSII), 2) artificial pancreas (AP), and 3) AP+MDA. Participants underwent three 9-h interventions involving breakfast with a bolus and lunch without a bolus. RESULTS: In AP+MDA, the meal detection time was 40.0 (interquartile range 40.0-57.5) min. Compared with CSII, AP+MDA decreased the 4-h postlunch incremental area under the curve (iAUC) from 24.1 ± 9.5 to 15.4 ± 8.0 h ⋅ mmol/L (P = 0.03). iAUC did not differ between AP+MDA and AP (19.6 ± 10.4 h ⋅ mmol/L, P = 0.21) or between AP and CSII (P = 0.33). The AP+MDA reduced time >10 mmol/L (58.0 ± 26.6%) compared with CSII (79.6 ± 27.5%, P = 0.02) and AP (74.2 ± 20.6%, P = 0.047). CONCLUSIONS: The AP+MDA improved glucose control after an unannounced meal.

Efficacy of a New Protocol of Premixed 70/30 Human Insulin in Haitian Youth with Diabetes.

INTRODUCTION: Controlling insulin-treated diabetes is challenging in low-resource settings where only Neutral Protamine Hagedorn (NPH), regular (R) and premixed insulin formulations are available, self-monitoring of blood glucose (SMBG) supplies are scarce and food insecurity is common. We examined the impact of a treatment protocol that includes sliding scale-based 70/30 insulin adjustments in Haiti. METHODS: Thirty young patients aged 11-28 years with diabetes treated with premixed 70/30 insulin twice daily were included in the study. The participants performed one or two daily self-monitoring of blood glucose (SMBG) tests and attended our diabetes clinic monthly. They were randomized to two treatment groups, with one group remaining on the 70/30 insulin formulation (group 70 [G70]) and the other group switching to self-mixed NPH + R (group NR [GNR]). Sliding scales for insulin correction doses and meal insulin doses were designed based on the total daily insulin dose (TDD), carbohydrate ratio and insulin sensitivity factor. SMBG tests and insulin were administered before the morning and evening meals. The frequency of visits to the diabetes clinic was increased to biweekly during a 14-week follow-up. RESULTS: Fifteen patients of each group were included in the analysis. Baseline characteristics, increase in total daily dose and number of missed SMBG tests and skipped meals at 14 weeks did not differ between the two groups. Hemoglobin A1c (HbA1c) decreased from 9.5% (interquartile range [IQR] 8.8, 10.5) (80.3 mmol/mol) to 8.0% (IQR 7.1%, 9.0%) (63.9 mmol/mol) in G70 (p = 0.01), and from 10.6% (IQR 8.1,% 13.1)% (92.4 mmol/mol) to 9.0% (IQR 7.6%, 9.6%) (74.9 mmol/mol) in GNR (p = 0.10), with no significant between-group difference in reductions (p = 0.12). No serious acute complications were reported. Stopping the use of sliding scales and resuming monthly visits increased HbA1c to values not significantly different from baseline in both groups after 15 weeks. CONCLUSION: The use of sliding scales adjusted for missed SMBG tests and skipped meals, and frequent clinic visits that focus on patient self-management education significantly improved glycemic control in the patients with youth-onset diabetes in our study treated with premixed 70/30 human insulin in a low-resource setting.