One Size Fits All Versus Individualized Medicine in Type 1 Diabetes Management.

Diabetes is primarily a self-managed disease that requires patients to perform multiple daily tasks. However, adherence to treatment may be negatively impacted by each patient's individual physical abilities, emotional issues, and lifestyle circumstances, although the "one size fits all" was necessary due to limited treatment options. This article reviews milestones of diabetes care, provides the rationale for individualizing diabetes management, and presents a potential roadmap for utilizing current and future technologies to transition from reactive medicine to proactive disease management and prevention in the future under the umbrella of individualized care.

Continuous Ketone Monitoring Consensus Report 2021.

This article is the work product of the Continuous Ketone Monitoring Consensus Panel, which was organized by Diabetes Technology Society and met virtually on April 20, 2021. The panel consisted of 20 US-based experts in the use of diabetes technology, representing adult endocrinology, pediatric endocrinology, advanced practice nursing, diabetes care and education, clinical chemistry, and bioengineering. The panelists were from universities, hospitals, freestanding research institutes, government, and private practice. Panelists reviewed the medical literature pertaining to ten topics: (1) physiology of ketone production, (2) measurement of ketones, (3) performance of the first continuous ketone monitor (CKM) reported to be used in human trials, (4) demographics and epidemiology of diabetic ketoacidosis (DKA), (5) atypical hyperketonemia, (6) prevention of DKA, (7) non-DKA states of fasting ketonemia and ketonuria, (8) potential integration of CKMs with pumps and automated insulin delivery systems to prevent DKA, (9) clinical trials of CKMs, and (10) the future of CKMs. The panelists summarized the medical literature for each of the ten topics in this report. They also developed 30 conclusions (amounting to three conclusions for each topic) about CKMs and voted unanimously to adopt the 30 conclusions. This report is intended to support the development of safe and effective continuous ketone monitoring and to apply this technology in ways that will benefit people with diabetes.

Approach to Using Trend Arrows in the FreeStyle Libre Flash Glucose Monitoring Systems in Adults.

The use of personal continuous glucose monitoring (CGM) has expanded dramatically among individuals with diabetes. CGM systems provide retrospective data, as well as the current glucose value and trend arrow data, which indicate the direction and velocity of changing glucose. In 2017, Aleppo and colleagues developed a simplified approach for adults with diabetes to safely adjust rapid-acting insulin doses using trend arrow information in the Dexcom G5 CGM system. Since then, the FreeStyle Libre and FreeStyle Libre 14-day CGM systems have become available in the United States; however, guidance on using trend arrow data that take the unique features of these systems into consideration is lacking. Specifically, the FreeStyle Libre systems do not have automatic alarms, which impact how the system and trend arrow data are used. The Endocrine Society convened an expert panel to address this gap and develop an approach to adjusting rapid-acting insulin doses for adults using trend arrows in the FreeStyle Libre systems. We based our approach on previous work and expanded upon engagement and scanning recommendations, and we incorporated pre-exercise planning specific to these systems. Our approach provides insulin dose adjustments as discrete insulin units based on an individual's insulin sensitivity and directionality of the trend arrow. We focus on the needs of patients treated with multiple daily injections because these individuals currently make up a greater proportion of individuals on intensive insulin therapy. Our recommendations are intended to provide a safe, practical approach to using trend arrows in the FreeStyle Libre systems.

The Interactive Effect of Diabetes Family Conflict and Depression on Insulin Bolusing Behaviors for Youth.

OBJECTIVE: Adherence to type 1 diabetes management declines as children enter adolescence. For youth, psychosocial variables including mood and interpersonal relationships play a large role in diabetes maintenance. The current study assessed the unique and interactive roles diabetes family conflict and depression have on insulin bolusing behaviors for youth ages 10-16 years. METHODS: Ninety-one youth-parent dyads completed a survey assessing family conflict and depression. Mean daily blood glucose levels, mealtime insulin bolus scores ( BOLUS), and glycated hemoglobin (HbA1c) were collected from the medical record as outcome variables. RESULTS: Parent-reported diabetes-related family conflict and youths' endorsed depression both significantly predicted insulin bolusing behavior, R2 = .13, F(2, 88) = 6.66, P < .05. The interaction of diabetes family conflict and youth depression played a significant role in youths' bolusing behaviors, above and beyond that which was predicted by conflict and depression separately, R2 = .18, Fchange(1, 87) = 4.63, P < .05. BOLUS was negatively related to youths' hemoglobin A1c, r = -.556, P < .001 and mean daily blood glucose levels, r = -.428, P < .001. CONCLUSIONS: Among depressed youth, mealtime insulin BOLUS scores declined with greater diabetes-related family conflict, while there was no change in BOLUS scores among depressed youth living in families reporting less conflict. Findings underscore the importance of screening for depression and family conflict in youth experiencing or at risk for poor adherence to mealtime insulin and higher HbA1c levels.

Pilot study results for a novel behavior plus nutrition intervention for caregivers of young children with type 1 diabetes.

OBJECTIVE: To present results for a parent-based educational intervention targeting mealtime behaviors plus nutrition among families of young children (mean age, 5.0 ± 1.2 years) with type 1 diabetes mellitus (T1DM). METHODS: The researchers recruited 9 caregivers who participated in the 6-session intervention and completed baseline and posttreatment assessments, which included dietary intake, acceptability of diet changes, mealtime behavior, and mean blood glucose values. RESULTS: Children's mean daily blood glucose levels decreased from 185 ± 46 mg/dL to 159 ± 40 mg/dL (P < .001). There were also decreases in problematic parent and child mealtime behaviors. There was no change in children's dietary intake indicators that could be detected. CONCLUSIONS AND IMPLICATIONS: It appears promising that this targeted behavior plus nutrition intervention can improve glycemic control and behavior for young children with type 1 diabetes mellitus. Larger, randomized controlled trials will clarify significant results, limitations, and sustainability. Techniques within the program may have application to current practice.

A comparison of average daily risk range scores for young children with type 1 diabetes mellitus using continuous glucose monitoring and self-monitoring data.

BACKGROUND: Young children with type 1 diabetes are vulnerable to glycemic excursion. Continuous glucose monitoring (CGM), combined with variability statistics, can offer a richer and more complete picture of glycemic variability in young children. In particular, we present data for the Average Daily Risk Range (ADRR) and compare ADRR scores calculated using CGM versus self-monitoring of blood glucose (SMBG) data for young children. METHODS: CGM and SMBG data from 48 young children with type 1 diabetes (mean age, 5.1 years) were used to calculate two separate ADRR scores, using SMBG data (ADRRs) and CGM data (ADRRc), for each child. Additionally, we calculated mean amplitude of glycemic excursion (MAGE) scores for children to examine the concurrent validity of the ADRRs and ADRRc. RESULTS: Young children's mean ADRRc score was significantly greater than their ADRRs score (55±12 and 46±11, respectively; P<0.001). In addition, 74% of the time the children's ADRRc score reflected greater variability risk than their ADRRs score. Examining the concurrent validity, children's ADRRc scores correlated positively with MAGE scores calculated using their CGM and SMBG data, whereas their ADRRs scores only correlated with MAGE scores calculated using SMBG. CONCLUSIONS: ADRR scores generated for young children with type 1 diabetes demonstrate a high risk for glucose variability, but ADRR scores generated from CGM data may provide a more sensitive measure of variability than ADRR scores generated from SMBG. In young children with type 1 diabetes, ADRR scores calculated from CGM data may be superior to scores calculated from SMBG for measuring risk of excursion.

Recombinant insulin-like growth factor (IGF)-I treatment in short children with low IGF-I levels: first-year results from a randomized clinical trial.

CONTEXT: Short stature in children may be associated with low IGF-I despite normal stimulated GH levels and without other causes. OBJECTIVE: Our objective was to assess the safety and efficacy of recombinant human IGF-I (rhIGF-I) in short children with low IGF-I levels. DESIGN: This was a 1-yr, randomized, open-label trial (MS301). SETTING: The study was conducted at 30 U.S. pediatric endocrinology clinics. SUBJECTS: A total of 136 short, prepubertal subjects with low IGF-I (height and IGF-I sd scores <-2, stimulated GH > or =7 ng/ml); 124 completed the study, and six withdrew for adverse events and six for other reasons. INTERVENTION: rhIGF-I was administered sc, twice daily using weight-based dosing (40, 80, or 120 microg/kg; n = 111) or subjects were observed (n = 25). MAIN OUTCOME MEASURES: First-year height velocity (centimeters per year, cm/yr), height sd score, IGF-I, and adverse events were prespecified outcomes. RESULTS: First-year height velocities for subjects completing the trial were increased for the 80- and 120-microg/kg twice-daily vs. the untreated group (7.0 +/- 1.0, 7.9 +/- 1.4, and 5.2 +/- 1.0 cm/yr, respectively; all P < 0.0001) and for the 120- vs. 80-microg/kg group (P = 0.0002) and were inversely related to age. They were not predicted by GH stimulation or IGF-I generation test results and were not correlated with IGF-I antibody status. The most commonly reported adverse events of special interest during treatment were headache (38% of subjects), vomiting (25%), and hypoglycemia (14%). CONCLUSIONS: rhIGF-I treatment was associated with age- and dose-dependent increases in first-year height velocity. Adverse events during treatment were less common than in previous studies and were generally transient, easily managed, and without known sequelae.

Noninvasive radial artery tonometry augmentation index and urinary albumin/creatinine levels in early adolescents with type 1 diabetes mellitus.

Patients with type 1 diabetes mellitus (DM1) are at an even greater risk compared to the general population for the development of cardiovascular disease. Studies have determined that the pathological changes seen in atherosclerosis develop at a very early age. There is a growing consensus within the medical community that early identification of chronic disease may help to reduce morbidity and mortality. The aim of this study was to assess the degree of arterial stiffness by measuring the augmentation index (AIx), using noninvasive radial artery tonometry, in adolescent children with DM1 compared with age-matched controls. In addition, urinary albumin/creatinine ratios were obtained to assess a possible relationship between renal and cardiac dysfunction in patients with DM1. Forty-five adolescents with DM1 and 42 controls between the ages of 12 and 14 years were recruited. Radial artery stiffness and urinary albumin/creatinine ratios of the adolescents with DM1 were not different from controls.

When should cranial magnetic resonance imaging be used in girls with early sexual development?

OBJECTIVE: To determine whether concise parameters can be established in girls who present with signs of early puberty before the age of 8 years, which would help to identify those in whom cranial magnetic resonance imaging (MRI) is indicated. METHODS: A retrospective chart review was undertaken over a 10-year period from 1992-2002. The two requirements for inclusion in this study were girls who manifested pubertal changes before the age of 8.0 years and who underwent MRI of the brain. The records of 130 female patients with the presumptive diagnosis of precocious puberty (PP) were evaluated. Patients' medical records were reviewed for histories of any reported focal neurological complaint suspicious for intracranial lesions, such as headaches, seizures, or visual disturbances, as well as menses and advanced bone age (>2 SD) compared to chronological age. Seventy-five patients met these criteria and were divided into two groups. Group I consisted of nine patients with abnormal cranial MRI; Group II consisted of 66 patients with normal MRI. RESULTS: The patients in each group who had one or more of the central nervous system (CNS) signs and symptoms of early sexual development that were evaluated were markedly different. In Group I, 89% (CI 52-99.7%) had positive signs and symptoms that were suspicious for an intracranial lesion. In Group II, 94% (CI 85-98%), 63 of 66 girls, had no CNS signs or symptoms. CONCLUSION: The use of cranial MRI in the evaluation of girls with early sexual development is excessive. Girls with signs of pubertal development before age 8 years should be evaluated and followed. Those with specific CNS signs and symptoms, menses, and girls with a rapid advance in sexual development should undergo cranial MRI. Using this approach, far fewer patients in our study would have had cranial MRI.

Are pubertal changes in girls before age 8 benign?

OBJECTIVE: The Lawson Wilkins Pediatric Endocrine Society recently issued new recommendations for the age at which puberty should be considered precocious, lowering the prevailing standards from 8 years to 7 years for white girls and to 6 years for black girls. The new recommendations were based on a single epidemiologic study that focused on the conditions of premature thelarche and premature adrenarche (both characterized by a single sign of puberty). Although the data were available, the authors did not comment on the low incidence of true precocious puberty (characterized by breast and pubic hair development) in their population. The hypothesis for the present study is that the new recommendations lead to underdiagnosis of endocrine pathology METHODS: Using 29 International Classification of Diseases, Ninth Revision codes for diagnoses known to be associated with precocious puberty, we identified 1570 patient visits to our outpatient pediatric endocrinology clinic of white girls aged 7 to 8 and black girls aged 6 to 8 during a 5-year period RESULTS: Of the 1570 patient visits, 223 unique patients were identified as having been referred for the sole finding of precocious pubertal development. These 223 patients carried no other endocrine diagnoses. Eleven patients (4.9%) were found to have no true breast buds and no terminally differentiated pubic hair. A total of 105 (47.1%) of 223 patients were found to have 2 signs of puberty, consistent with true precocious puberty according to the conventional guidelines of precocity of 8 years in girls. Overall, 12.3% of patients also had diagnoses of other endocrine conditions that included congenital adrenal hyperplasia, McCune-Albright syndrome, growth hormone deficiency, hypothyroidism, hyperinsulinism, pituitary adenoma, and neurofibromatosis. A total of 35.2% of girls with true precocious puberty exhibited bone ages >3 standard deviations above the mean, indicating markedly diminished growth potential CONCLUSIONS: We conclude that signs of puberty in 6- to 8-year-old girls should not be considered normal or benign. Implementation of the new guidelines for the evaluation of puberty will result in failure to identify conditions that respond to early intervention.