Pharmacokinetic and pharmacodynamic profile of the sodium-glucose co-transporter-2 inhibitor empagliflozin in young people with Type 2 diabetes: a randomized trial.

AIMS: To assess the pharmacokinetic and pharmacodynamic profile of a single dose of empagliflozin in young people with Type 2 diabetes to identify the appropriate doses for further paediatric development. METHODS: We conducted a single-dose, open-label, randomized, parallel-group study with empagliflozin 5 mg, 10 mg and 25 mg in young people with Type 2 diabetes aged 10-17 years. RESULTS: Of 39 participants screened, 27 were randomized and completed the study; their mean (± sd) age was 14.1±2.0 years and body weight was 96.7±23.5 kg. Compared with similar studies in adults with Type 2 diabetes, the maximum observed plasma concentrations were slightly lower with the 10-mg and 25-mg doses, and the area under the plasma concentration-time curve was slightly lower with the 10-mg but slightly higher with the 25-mg dose. The adjusted mean increases in urinary glucose excretion were 53 g/24 h (95% CI 32,74), 73 g/24 h (95% CI 52,94) and 87 g/24 h (95% CI 68,107), and the adjusted mean decreases in fasting plasma glucose were 0.9 mmol/l (95% CI -1.6,-0.1), 0.9 mmol/l (95% CI -1.7,-0.2) and 1.1 mmol/l (95% CI -1.8,-0.5) for the 5- 10- and 25-mg doses, respectively. There were no serious adverse events and one investigator-reported drug-related event (dehydration). CONCLUSIONS: After a single oral dose of empagliflozin, adults and young people with Type 2 diabetes had similar exposure-response relationships after adjusting for significant covariates. These data support testing 10-mg and/or 25-mg doses of empagliflozin in an upcoming paediatric phase III Type 2 diabetes trial. (ClinicalTrials.gov registration no.: NCT02121483).

Validation of the Diabetes Family Impact Scale: a new measure of diabetes-specific family impact.

AIMS: To develop and validate the Diabetes Family Impact Scale, a scale to measure the impact of diabetes on families. METHODS: The Diabetes Family Impact Scale was developed by an iterative process, with input from multidisciplinary diabetes providers and parents of children with Type 1 diabetes. The psychometric properties of the Diabetes Family Impact Scale were assessed in parents of children with Type 1 diabetes. This assessment included internal consistency, convergent validity and exploratory factor analysis. RESULTS: Parents (n = 148) of children (mean ± sd age 12.9 ± 3.3 years) with Type 1 diabetes (mean ± sd duration 6.2 ± 3.6 years) completed the 15-item Diabetes Family Impact Scale. After eliminating one item, the 14-item measure demonstrated good internal consistency (Cronbach's α  =  0.84). Correlations between the Diabetes Family Impact Scale and measures of parent diabetes burden (r = 0.48, P < 0.0001), stressful life events (r = 0.28, P = 0.0007), and child's quality of life (r = -0.52 and -0.54, P < 0.0001 for generic and diabetes-specific quality of life, respectively) supported the convergent validity of the instrument. Factor analysis identified four factors corresponding to the four survey domains (school, work, finances and family well-being). CONCLUSIONS: The Diabetes Family Impact Scale measures diabetes-specific family impacts with good internal consistency and convergent validity and may be a useful tool in clinical and research settings.

Validation of a contemporary adherence measure for children with Type 1 diabetes: the Diabetes Management Questionnaire.

AIMS: To evaluate the psychometric properties of the Diabetes Management Questionnaire, a brief, self-report measure of adherence to contemporary diabetes management for young people with Type 1 diabetes and their caregivers. METHODS: A total of 273 parent-child dyads completed parallel versions of the Diabetes Management Questionnaire. Eligible children (aged 8-18 years) had Type 1 diabetes for ≥1 year. A multidisciplinary team designed the Diabetes Management Questionnaire as a brief, self-administered measure of adherence to Type 1 diabetes management over the preceding month; higher scores reflect greater adherence. Psychometrics were evaluated for the entire sample and according to age of the child. RESULTS: The children (49% female) had a mean ± sd (range) age 13.3 ± 2.9 (8-18) years and their mean ± sd HbA1c was 71 ± 15 mmol/mol (8.6 ± 1.4%). Internal consistency was good for parents (α = 0.83) and children (α = 0.79). Test-retest reliability was excellent for parents (intraclass correlation coefficient =0.83) and good for children (intraclass correlation coefficient = 0.65). Parent and child scores had moderate agreement (intraclass correlation coefficient = 0.54). Diabetes Management Questionnaire scores were inversely associated with HbA1c (parents: r = -0.41, P < 0.0001; children: r = -0.27, P < 0.0001). Psychometrics were stronger in the children aged ≥13 years compared with those aged < 13 years, but were acceptable in both age groups. Mean ± sd Diabetes Management Questionnaire scores were higher among children who were receiving insulin pump therapy (n = 181) than in children receiving multiple daily injections (n = 92) according to parent (75.9 ± 11.8 vs. 70.5 ± 15.5; P = 0.004) and child report (72.2 ± 12.1 vs. 67.6 ± 13.9; P = 0.006). CONCLUSIONS: The Diabetes Management Questionnaire is a brief, valid self-report measure of adherence to contemporary diabetes self-management for people aged 8-18 years who are receiving either multiple daily injections or insulin pump therapy.

Associations of family meal frequency with family meal habits and meal preparation characteristics among families of youth with type 1 diabetes.

BACKGROUND: While benefits of family mealtimes, such as improved dietary quality and increased family communication, have been well-documented in the general population, less is known about family meal habits that contribute to more frequent family meals in youth with type 1 diabetes. METHODS: This cross-sectional study surveyed 282 youth ages 8-18 years with type 1 diabetes and their parents on measures regarding diabetes-related and dietary behaviours. T-tests determined significant differences in youth's diet quality, adherence to diabetes management and glycaemic control between those with and without regular family meals (defined as ≥ 5 meals per week). Logistic regression analyses determined unadjusted and adjusted associations of age, socio-demographics, family meal habits, and family meal preparation characteristics with regular family meals. RESULTS: 57% of parents reported having regular family meals. Families with regular family meals had significantly better diet quality as measured by the Healthy Eating Index (P < 0.05) and the NRF9.3 (P < 0.01), and adherence to diabetes management (P < 0.001); the difference in glycaemic control approached statistical significance (P = 0.06). Priority placed on, pleasant atmosphere and greater structure around family meals were each associated with regular family meals (P < 0.05). Meals prepared at home were positively associated with regular family meals, while convenience and fast foods were negatively associated (P < 0.05). Families in which at least one parent worked part-time or stayed at home were significantly more likely to have regular family meals than families in which both parents worked full-time (P < 0.05). In the multivariate logistic regression model, greater parental priority given to family mealtimes (P < 0.001) and more home-prepared meals (P < 0.001) predicted occurrence of regular family meals; adjusting for parent work status and other family meal habits. CONCLUSIONS: Strategies for promoting families meals should not only highlight the benefits of family meals, but also facilitate parents' skills for and barriers to home-prepared meals.

The impact of blood glucose and HbA(1c) goals on glycaemic control in children and adolescents with Type 1 diabetes.

AIMS: To evaluate parents' goals and parents' perceptions of physicians' goals for blood glucose and HbA(1c) in children and adolescents with Type 1 diabetes. METHODS: In a cross-sectional observational assessment, parents (80% mothers) of 153 children/adolescents (56% female), aged 12.9 ± 2.3 years (range 8-16 years) with Type 1 diabetes for 6.3 ± 3.5 years, completed surveys regarding their goals and their perceptions of physicians' goals for their child's blood glucose and HbA(1c) levels. RESULTS: Children/adolescents had a mean HbA(1c) of 69 ± 16 mmol/mol (8.4 ± 1.4%) and checked blood glucose levels 3.8 ± 1.2 times/day; 23% received pump therapy. Almost half of parents reported a blood glucose goal of 130 (80-180) mg/dl [7.2 (4.4-10) mmol/l]; 75% of parents reported a HbA(1c) goal of 42-64 mmol/mol (6-8%). HbA(1c) was significantly lower when parents reported HbA(1c) goals ≤ 64 mmol/mol (≤ 8%) vs. > 64 mmol/mol (> 8%) [67 ± 14 mmol/mol (8.3 ± 1.2%) vs. 76 ± 20 mmol/mol (9.1 ± 1.8%), respectively, P = 0.02]. Parents' blood glucose and HbA(1c) goals were tightly linked with parents' perceptions of physicians' blood glucose and HbA(1c) goals (69% concordant, P < 0.0001; 88% concordant, P < 0.0001, respectively). CONCLUSIONS: There was a significant association between lower parent HbA(1c) goals and lower child/adolescent HbA(1c) . Further, parents appear to set glycaemic goals based upon their perceptions of physician goals. Future studies should assess the relationship between parents' perceptions of health-care providers' goals and health-care providers' actual goals and the impact of unified family/provider goal-setting on glycaemic control.

Transitions in care: support group for young adults with Type 1 diabetes.

AIMS: Young adulthood is a challenging period for patients with Type 1 diabetes as developmental changes complicate Type 1 diabetes management and gaps in care may arise as patients transition from paediatric to adult providers. This period has been associated with worsening diabetes outcomes. One approach to aid young adults during this transition period could entail professionally led support groups to enhance self-motivation and facilitate peer-to-peer interactions. We implemented and evaluated a support group for young adults with Type 1 diabetes as a pilot project. METHODS: Young adults with Type 1 diabetes (18-30 years) participated in monthly, professionally led support groups for 5 months. Questionnaires were completed pre- and post-group and chart review data were collected regarding glycaemic control and visit frequency in the year before and after group participation. RESULTS: Participation in the group was associated with improvement in HbA(1c) and decreased self-reported diabetes burden, along with a trend for an increase in diabetes-related self-care behaviours. Frequency of visits did not vary from pre- to post-group. Discussion topics identified by participants included managing diabetes in day-to-day life, experiences and interactions with others who do not have diabetes and emotions related to diabetes. Participants identified that they sought a diabetes care team that offers knowledge, support and a multidisciplinary team. CONCLUSIONS: Professionally led support groups may have utility for increasing social support and optimizing diabetes outcomes in young adults with Type 1 diabetes.

Re-examining a measure of diabetes-related burden in parents of young people with Type 1 diabetes: the Problem Areas in Diabetes Survey - Parent Revised version (PAID-PR).

AIMS: In a pediatric patients, the burden of diabetes lies within the family. In the current era of intensive insulin therapy, perceived parental burden may affect the family's efforts at effective diabetes management. The aims of this study were to re-examine and revise a measure of perceived parental burden associated with caring for a child with diabetes in the current era. METHODS: A geographically diverse population of young people (N = 376) with Type 1 diabetes and their parents included participants in the Juvenile Diabetes Research Foundation continuous glucose monitoring study and patients from the Joslin Diabetes Center. Participants provided data on demographics, diabetes management, diabetes-specific family conflict, and quality of life at baseline and after 6 months of follow-up. RESULTS: Young people were 12.9 ± 2.7 years old with diabetes duration of 6.3 ± 3.5 years. Mean HbA(1C) was 8.0 ± 1.2%(64 mmol/mol), 58% received insulin pump therapy, and young people monitored blood glucose 5.2 ± 2.3 times/day. Factor analysis yielded two factors, 'Immediate Burden' and 'Theoretical Burden'. The Problem Areas in Diabetes Survey - Parent Revised version (PAID-PR) demonstrated excellent internal consistency (Cronbach's α = 0.87; factor 1 α = 0.78; factor 2 α = 0.83). Greater parental burden was associated with more frequent blood glucose monitoring, higher HbA(1C) levels, greater diabetes-specific family conflict, and lower quality of life. Test-retest analysis was acceptable (r = 0.62). CONCLUSIONS: The PAID-PR demonstrated excellent internal consistency, good test-retest reliability, and associations with diabetes-specific family conflict and quality of life. This brief measure may have both clinical and research utility in the management of young people with Type 1 diabetes.

Associations of food preferences and household food availability with dietary intake and quality in youth with type 1 diabetes.

The objective of this study was to examine associations of food preferences and availability with dietary intake in youth with type 1 diabetes, for whom dietary intake and quality are essential to disease management. Youth (n=252, age 13.2±2.8 y, diabetes duration 6.3±3.4 y) reported preferences and parents reported household availability for 61 food items categorized as fruit, vegetables, whole grains, refined grains and fats/sweets. Youth energy-adjusted daily servings of food groups, Healthy Eating Index-2005 and Nutrient Rich Foods 9.3 scores were calculated from 3-day diet records. Associations of dietary intake and quality variables with preference and availability of all food groups were evaluated by linear regressions adjusted for sociodemographic characteristics. Fruit and whole grain intake were positively related to corresponding preference and availability; whole grain intake and refined grain availability were inversely related. Vegetable, refined grain and fats/sweets intake were unrelated to preference and availability. Diet quality measures were related positively to fruit preference and whole grain availability and inversely to refined grains availability. Findings indicate associations of dietary intake with food preference and availability vary by food group in youth with type 1 diabetes. Measures of overall dietary quality were more consistently associated with food group availability than preferences.

Validation of an abbreviated adherence measure for young people with Type 1 diabetes.

AIMS: Adherence to diabetes-related tasks is an important construct. The Diabetes Self-Management Profile is a validated, semi-structured interview assessing adherence in paediatric patients with Type 1 diabetes. We created and validated a brief questionnaire version of the Diabetes Self-Management Profile called the Diabetes Self-Management Questionnaire. METHODS: Young people with Type 1 diabetes, ages 9-15 years (n = 338) and their parents provided data from chart review, interview and questionnaires. RESULTS: Diabetes Self-Management Questionnaire scores correlated significantly with Diabetes Self-Management Profile scores, HbA(1c) , blood glucose monitoring frequency and other measures associated with adherence and/or glycaemic control (P ≤ 0.01 for all). Young people and parent scores were correlated (r = 0.55, P < 0.0001). The Diabetes Self-Management Questionnaire demonstrated modest internal consistency (Cronbach's α = 0.59), adequate for a brief measure of multidimensional adherence. In addition, factor analysis confirmed one factor. CONCLUSIONS: This brief adherence questionnaire demonstrated construct validity in young people 9-15 years old and their parents and may have utility in clinical and research settings.

Comparison of longitudinal point-of-care and high-performance liquid chromatography HbA1c measurements in a multi-centre trial.

AIMS: Point-of-care HbA(1c) is routine in clinical practice. Comparison of point-of-care HbA(1c) against laboratory measurements across sites and over time is warranted. METHODS: One hundred and twenty-one young persons with Type 1 diabetes from four centres provided 450 paired samples collected over 10 months for point-of-care HbA(1c) and central laboratory-based high-performance liquid chromatography (HPLC) HbA(1c) determinations. Change in HbA(1c) over time was assessed by difference from initial to final HbA(1c) and by growth modelling with annualized slope calculation. Change in HbA(1c) was categorized as improved (decrease of ≥ 0.5% or negative slope), no change (± 0.4% of initial HbA(1c) or slope = 0) or worsened (increase of ≥ 0.5% or positive slope). RESULTS: The 450 paired samples (median of four pairs/patient) were highly correlated (r = 0.97, P < 0.0001), as were time-specific and site-specific pairs (r = 0.94 to 0.98, P < 0.0001). Initial-to-final point-of-care HbA(1c) and HPLC HbA(1c) changes were 0.3 ± 1.1% (range -2.7 to 4.1) and 0.4 ± 1.2% (-3.9 to 4.5), respectively, with 21% of patients (n = 26) discordant for change categories. ΔHbA(1c) by point-of-care HbA(1c) vs. HPLC HbA(1c) differed across the HbA(1c) range and by ≥ 0.5% absolute difference in ΔHbA(1c) in 14 (54%) of the 26 patients discordant for HbA(1c) change categories. Mean annual HbA(1c) slope was 0.4 ± 1.5% (-5.4 to 4.8) for point-of-care HbA(1c) and 0.4 ± 1.6% (-6.9 to 5.2) for HPLC HbA(1c), with 18% (n = 22 pairs) discordant for change categories. CONCLUSIONS: Assessment of absolute HbA(1c) change may not be different for point-of-care HbA(1c) compared with HPLC HbA(1c); however, misclassification of patients by discrete cut-off values may occur with point-of-care HbA(1c) compared with HPLC HbA(1c) determinations.

Occurrence of microalbuminuria in young people with Type 1 diabetes: importance of age and diabetes duration.

AIMS: To determine the occurrence of microalbuminuria in young people with Type 1 diabetes mellitus followed prospectively for 2 years and to relate the presence of persistent elevations in urinary albumin excretion (UAE) to age, diabetes duration, puberty and other factors. METHODS: During a 2 year period, random urine samples were obtained from 471 patients, aged 8-18 years (mean +/-sd 12.9 +/- 2.3 years) with Type 1 diabetes duration 5.6 +/- 3.0 years, as part of routine clinical care. Urine albumin and creatinine concentrations were measured in 1310 samples (median, 3 samples per patient) and the albumin:creatinine ratio was calculated (in micrograms albumin per milligram creatinine). Height, weight, blood pressure (BP), glycated haemoglobin (HbA(1c)), blood glucose monitoring frequency and Tanner staging were collected from patients' medical records. RESULTS: Twenty-three per cent of patients had one or more sample with elevated UAE (> or =20 microg/mg) and 9.3% had persistent elevations (> or =2 samples > or =20 microg/mg). Those with and without persistent microalbuminuria did not differ significantly in age, diabetes duration, z-score for body mass index, pubertal status or BP percentile. Ten per cent of children <13 years old and 9% of children > or =13 years old had persistent microalbuminuria. Persistent microalbuminuria was significantly associated with diabetes duration only in older children (duration 0.5-3 years, 4%; 4-6 years, 8%; > or =7 years, 14%; P = 0.02, trend test). Mean HbA(1c) over the 2 years was 8.7 +/- 1.2%. In a logistic regression model, mean HbA(1c) was the only significant predictor of persistent microalbuminuria (odds ratio 1.3, 95% confidence interval 1.0-1.6, P = 0.05). CONCLUSIONS: Microalbuminuria in older children with Type 1 diabetes is likely to be clinically significant. In younger children, it may reflect functional, reversible renal changes. Longitudinal analysis is needed to confirm the probable transient nature of microalbuminuria in young patients with Type 1 diabetes.

Diabetes-specific family conflict and psychological distress in paediatric Type 1 diabetes.

AIMS: Diabetes-specific family conflict is associated with suboptimal adherence and glycaemic control. Little is known about the individual and family factors associated with diabetes-specific family conflict. The purpose of this study was to examine whether background factors (e.g. age, gender), diabetes variables (e.g. duration of diabetes, adherence, glycaemic control) and psychological distress (i.e. depression and anxiety) in parents and children and adolescents were associated with diabetes-specific family conflict. METHODS: Participants were 187 children and adolescents with Type 1 diabetes and their parents. Study measures assessed diabetes-specific family conflict, youth depression and parent depression and anxiety. Demographic and disease-specific data (adherence, glycaemic control) were also collected. RESULTS: Findings suggested a close link between psychological distress in parents and children and adolescents and reports of increased diabetes-specific family conflict. In the presence of suboptimal glycaemic control, children and adolescents and parents reported more family conflict. Adherence was not significantly associated with family conflict. CONCLUSIONS: This study highlights the importance of considering the impact of individual psychological functioning on family conflict and also suggests a bidirectional relationship between conflict and glycaemic control.

Self-reported history of overweight and its relationship to disordered eating in adolescent girls with Type 1 diabetes.

AIMS: Increased body weight and disordered eating attitudes/behaviours are common in adolescent girls with Type 1 diabetes (T1D). Disordered eating increases risks for diabetes-related complications. This study aimed to identify a rapid screening approach for disordered eating attitudes and behaviours in adolescent girls with T1D and to examine the relationship between disordered eating and body weight in this population. METHODS: Ninety adolescent girls, aged 12-19 years, provided a self-assessment of weight status. Participants also completed questionnaires to assess attitudes/behaviours toward food and eating, appetitive responsiveness to the food environment, disinhibition in eating and weight history. RESULTS: Forty-three per cent of participants reported a history of overweight. Compared with participants who reported never being overweight, those who reported ever being overweight were significantly older, scored significantly higher on all measures of disordered eating attitudes/behaviours (P < or = 0.009) and were 4.8 times more likely to be currently overweight or obese (P < 0.001). Glycated haemoglobin (HbA(1c)) was similar between those who did and did not report ever being overweight. CONCLUSIONS: Because of the ill-health effects of disordered eating and the higher rate of overweight in adolescent girls with T1D, effective screening tools are warranted. The single question 'Have you ever been overweight?' may be sufficient as a first question to screen for those at high risk for disordered eating attitudes/behaviours and to provide early intervention and prevention.

Relationships of neophobia and pickiness with dietary variety, dietary quality and diabetes management adherence in youth with type 1 diabetes.

BACKGROUND/OBJECTIVES: Neophobia, pickiness and diet variety are associated with diet quality and health outcomes in young children. Limited research has examined these associations among youth with type 1 diabetes (T1D), a population at risk for poor health outcomes when dietary quality is inadequate. SUBJECTS/METHODS: Youth (n=252, age 13.2 ± 2.8 years, 92% white, diabetes duration 6.3 ± 3.4 years) with T1D and their parents completed 3-day youth diet records; parents completed questionnaires regarding youth neophobia, pickiness and diabetes management adherence. Medical records provided biomedical data. Dietary quality indicators included Nutrient-Rich Foods Index 9.3 (NRF9.3), Healthy Eating Index-2005 (HEI-2005), Whole Plant Food Density (WPFD) and key single nutrients. Dietary variety was operationalized as a count of 20 recommended food groups consumed. Relationships of dietary quality and diabetes management adherence with neophobia, pickiness and dietary variety as independent variables were examined using multiple linear regression analyses adjusted for total energy intake, age, height and weight. RESULTS: In multiple linear regression analyses, NRF9.3 and HEI-2005 were each inversely associated with neophobia and pickiness, and positively associated with dietary variety. WPF and potassium were each positively associated and saturated fat was inversely associated with dietary variety. However, in models simultaneously including neophobia, pickiness and dietary variety as independent correlates of dietary quality, only relationships with dietary variety remained significant. Diabetes management adherence was negatively associated with both neophobia and pickiness and positively associated with dietary variety. CONCLUSIONS: Findings suggest that increasing dietary variety may contribute toward improved dietary quality among youth with T1D, despite potentially adverse influences of neophobia and pickiness.

Sick day management using blood 3-hydroxybutyrate (3-OHB) compared with urine ketone monitoring reduces hospital visits in young people with T1DM: a randomized clinical trial.

AIMS: Diabetic ketoacidosis (DKA), a life-threatening acute complication of Type 1 diabetes, may be preventable with frequent monitoring of glycaemia and ketosis along with timely supplemental insulin. This prospective, two-centre study assessed sick day management using blood 3-hydroxybutyrate (3-OHB) monitoring compared with traditional urine ketone testing, aimed at averting emergency assessment and hospitalization. METHODS: One hundred and twenty-three children, adolescents and young adults, aged 3-22 years, and their families received sick day education. Participants were randomized to receive either a blood glucose monitor that also measures blood 3-OHB (blood ketone group, n = 62) or a monitor plus urine ketone strips (urine ketone group, n = 61). All were encouraged to check glucose levels > or = 3 times daily and to check ketones during acute illness or stress, when glucose levels were consistently elevated (> or = 13.9 mmol/l on two consecutive readings), or when symptoms of DKA were present. Frequency of sick days, hyperglycaemia, ketosis, and hospitalization/emergency assessment were ascertained prospectively for 6 months. RESULTS: There were 578 sick days during 21,548 days of follow-up. Participants in the blood ketone group checked ketones significantly more during sick days (276 of 304 episodes, 90.8%) than participants in the urine ketone group (168 of 274 episodes, 61.3%) (P < 0.001). The incidence of hospitalization/emergency assessment was significantly lower in the blood ketone group (38/100 patient-years) compared with the urine ketone group (75/100 patient-years) (P = 0.05). CONCLUSIONS: Blood ketone monitoring during sick days appears acceptable to and preferred by young people with Type 1 diabetes. Routine implementation of blood 3-OHB monitoring for the management of sick days and impending DKA can potentially reduce hospitalization/emergency assessment compared with urine ketone testing and offers potential cost savings.

Family conflict, adherence, and glycaemic control in youth with short duration Type 1 diabetes.

AIMS: Behavioural support around diabetes management tasks is linked to glycaemic outcomes. In this study we investigated the relationship between diabetes-related parental behaviours (conflict around and involvement in treatment tasks), adherence to blood glucose monitoring (BGM), and glycaemic control in youth with short duration Type 1 diabetes mellitus (DM). METHODS: In a cross-sectional study, 104 youth (aged 8-17 years, duration of Type 1 DM 0.5-6 years) along with a parent, completed the Diabetes Conflict Scale. Parental involvement in management tasks was assessed with structured interviews and the Diabetes Family Responsibility Questionnaire. Adherence to BGM was evaluated by family report and by independent clinician rating. Glycaemic control was assessed with glycosylated haemoglobin (HbA1c) (ref. range, 4-6%). RESULTS: Children (8-12 years; n = 69) and adolescents (13-17 years; n = 35), respectively, had similar durations of diabetes (x +/- sd; 2.7 +/- 1.69, 2.4 +/- 1.32 years) and similar glycaemic control (8.3 +/- 1.1%, 8.4 +/- 1.1%). In both age groups, parental involvement was a significant predictor of adherence to BGM (P = 0.01). Multivariate analyses, controlling for age, sex, disease duration, and BGM adherence, revealed that higher diabetes conflict significantly related to poorer glycaemic control (HbA1c) (R2 = 0.17; P < 0.01). CONCLUSIONS: These findings indicate that in this cohort, early in the course of diabetes, diabetes-specific conflict and adherence to BGM became strongly linked to the child's glycaemic control. This suggests that to insure optimal control, it may be beneficial to introduce targeted interventions to build positive family involvement and interaction around diabetes tasks early in the disease course, before negative behaviours become established.

Type 2 diabetes, obesity, and the renal response to blocking the renin system with irbesartan.

AIM: Our recent studies revealed a striking but variable enhancement of renal vasodilator responses to blockers of the renin-angiotensin system in subjects with diabetes mellitus, possibly reflecting the level of intrarenal activation of the renin-angiotensin system, and thus a risk of nephropathy. As obesity is a common finding in diabetic individuals, and obesity has been linked to an increase in plasma angiotensinogen levels, we enrolled diabetic subjects with a wide range of body mass index (BMI) for this study. METHODS: Twelve Type 2 diabetic subjects in balance on a low sodium diet participated after baseline renal plasma flow and glomerular filtration measurements were made. Each subject then received 150 mg irbesartan, and renal function was measured every 45 min for 4 h. RESULTS: The average vasodilator response to irbesartan was 174 +/- 33 ml/min. No correlation was found between renal plasma flow response to irbesartan and duration of diabetes, baseline glucose, or HbA1c level. BMI, our measure of obesity, was highly correlated to the renal response to irbesartan (r = 0.7; P = 0.01). CONCLUSIONS: Our findings suggest an important role for obesity in activating the intrarenal renin system, perhaps via production of angiotensinogen. BMI may be an indicator of risk of nephropathy.