The Maintain High Blood Glucose subscale of the child hypoglycemia fear survey: proposed preliminary cut points for screening youth with type 1 diabetes.

OBJECTIVE: To improve the clinical utility of the Maintain High Blood Glucose subscale of the Hypoglycemia Fear Surveys (HFS) by identifying clinically meaningful cut points associated with glycemic outcomes. METHODS: Youth (N = 994; 13.96 ± 2.3 years) with type 1 diabetes and their caregivers (N = 1,111; 72% female) completed the Child or Parent version of the HFS. Modal Score Distribution, Standard Deviation Criterion, and Elevated Item Criterion approaches were used to identify proposed preliminary cut points for the Maintain High Blood Glucose subscale. The association between proposed preliminary cut points was examined with youth glycemic outcomes. RESULTS: A cut point of ≥7 for the Maintain High Blood Glucose subscale on the Child HFS was associated with a greater percentage of blood glucose readings >180 mg/dl (p < .01), higher mean blood glucose (p < .001), and a higher hemoglobin A1c (p < .05). In subsequent multiple regression analyses, controlling for other factors associated with glycemia, the significant association between scores above ≥7 and higher mean blood glucose and higher hemoglobin A1c remained. A clinically useful cut point was not identified for caregivers. However, elevated youth scores on the Maintain High Blood Glucose subscale were positively associated with elevated caregiver scores (phi = .171, p < .001). CONCLUSIONS: The proposed preliminary cut point for the Maintain High Blood Glucose subscale will aid the type 1 diabetes care team in identifying youth whose behaviors may be contributing to their suboptimal glycemia.

SAI-CH-6: Development of a Short Form of the State Anxiety Inventory for Children At-Risk for Type 1 Diabetes.

OBJECTIVE: To develop a reliable and valid short form of the State Anxiety Subscale of the State-Trait Anxiety Inventory for Children (STAI-CH) in the Environmental Determinants of Diabetes in the Young (TEDDY) study. METHODS: A Development Sample of 842 10-year-old TEDDY children completed the STAI-CH State Subscale about their type 1 diabetes (T1D) risk. The best 6 items (three anxiety-present and three anxiety-absent) for use in a short form (SAI-CH-6) were identified via item-total correlations. SAI-CH-6 reliability was examined in a Validation Sample (n = 257) of children who completed the full 20-item STAI-CH State Subscale and then again in an Application Sample (n = 2,710) who completed only the SAI-CH-6. Expected associations between the children's SAI-CH-6 scores and country of residence, sex, T1D family history, accuracy of T1D risk perception, worry about getting T1D, and their parents' anxiety scores were examined. RESULTS: The SAI-CH-6 was reliable (α = 0.81-0.87) and highly correlated with the full 20-item STAI-CH State Subscale (Development Sample: r = 0.94; Validation Sample: r = 0.92). SAI-CH-6 scores detected significant differences in state anxiety symptoms associated with T1D risk by country, T1D family history, accuracy of T1D risk perception, and worry about getting T1D and were correlated with the child's parent's anxiety. CONCLUSION: The SAI-CH-6 appears useful for assessing children's state anxiety symptoms when burden and time limitations prohibit the use of the STAI-CH. The utility of the SAI-CH-6 in older children with and without chronic conditions needs to be assessed.

The association of physical activity to oral glucose tolerance test outcomes in multiple autoantibody positive children: The TEDDY Study.

OBJECTIVE: To examine the association of physical activity (PA), measured by accelerometry, to hemoglobin AIC (HbA1c) and oral glucose tolerance test (OGTT) outcomes in children who were multiple persistent confirmed autoantibody positive for type 1 diabetes (T1D). METHODS: The Environmental Determinants of Diabetes in the Young (TEDDY) multinational study followed children from birth. Children ≥3 years of age who were multiple persistent confirmed autoantibody positive were monitored by OGTTs every 6 months. TEDDY children's PA was measured by accelerometry beginning at 5 years of age. We examined the relationship between moderate plus vigorous (mod + vig) PA, HbA1c, and OGTT in 209 multiple autoantibody children who had both OGTT and PA measurements. RESULTS: Mod + vig PA was associated with both glucose and C-peptide measures (fasting, 120-min, and AUC); higher mod + vig PA was associated with a better OGTT response primarily in children with longer duration of multiple autoantibody positivity. Mod + vig PA also interacted with child age; lower mod + vig PA was associated with a greater increase in C-peptide response across age. Mod + vig PA was not related to fasting insulin, HOMA-IR or HbA1c. CONCLUSIONS: The OGTT is the gold standard for diabetes diagnosis and is used to monitor those at high risk for T1D. We found higher levels of mod + vig PA were associated with better OGTT outcomes in children ≥5 years of age who have been multiple autoantibody positive for longer periods of time. Physical activity should be the focus of future efforts to better understand the determinants of disease progression in high-risk children.

Is staff consistency important to parents' satisfaction in a longitudinal study of children at risk for type 1 diabetes: the TEDDY study.

BACKGROUND: Participants' study satisfaction is important for both compliance with study protocols and retention, but research on parent study satisfaction is rare. This study sought to identify factors associated with parent study satisfaction in The Environmental Determinants of Diabetes in the Young (TEDDY) study, a longitudinal, multinational (US, Finland, Germany, Sweden) study of children at risk for type 1 diabetes. The role of staff consistency to parent study satisfaction was a particular focus. METHODS: Parent study satisfaction was measured by questionnaire at child-age 15 months (5579 mothers, 4942 fathers) and child-age four years (4010 mothers, 3411 fathers). Multiple linear regression analyses were used to identify sociodemographic factors, parental characteristics, and study variables associated with parent study satisfaction at both time points. RESULTS: Parent study satisfaction was highest in Sweden and the US, compared to Finland. Parents who had an accurate perception of their child's type 1 diabetes risk and those who believed they can do something to prevent type 1 diabetes were more satisfied. More educated parents and those with higher depression scores had lower study satisfaction scores. After adjusting for these factors, greater study staff change frequency was associated with lower study satisfaction in European parents (mothers at child-age 15 months: - 0.30,95% Cl - 0.36, - 0.24, p < 0.001; mothers at child-age four years: -0.41, 95% Cl - 0.53, - 0.29, p < 0.001; fathers at child-age 15 months: -0.28, 95% Cl - 0.34, - 0.21, p < 0.001; fathers at child-age four years: -0.35, 95% Cl - 0.48, - 0.21, p < 0.001). Staff consistency was not associated with parent study satisfaction in the US. However, the number of staff changes was markedly higher in the US compared to Europe. CONCLUSIONS: Sociodemographic factors, parental characteristics, and study-related variables were all related to parent study satisfaction. Those that are potentially modifiable are of particular interest as possible targets of future efforts to improve parent study satisfaction. Three such factors were identified: parent accuracy about the child's type 1 diabetes risk, parent beliefs that something can be done to reduce the child's risk, and study staff consistency. However, staff consistency was important only for European parents. TRIAL REGISTRATION: NCT00279318 .

First-appearing islet autoantibodies for type 1 diabetes in young children: maternal life events during pregnancy and the child's genetic risk.

AIMS/HYPOTHESIS: Psychological stress has long been considered a possible trigger of type 1 diabetes, although prospective studies examining the link between psychological stress or life events during pregnancy and the child's type 1 diabetes risk are rare. The objective of this study was to examine the association between life events during pregnancy and first-appearing islet autoantibodies (IA) in young children, conditioned by the child's type 1 diabetes-related genetic risk. METHODS: The IA status of 7317 genetically at-risk The Environmental Determinants of Diabetes in the Young (TEDDY) participants was assessed every 3 months from 3 months to 4 years, and bi-annually thereafter. Reports of major life events during pregnancy were collected at study inception when the child was 3 months of age and placed into one of six categories. Life events during pregnancy were examined for association with first-appearing insulin (IAA) (N = 222) or GAD (GADA) (N = 209) autoantibodies in the child until 6 years of age using proportional hazard models. Relative excess risk due to interaction (RERI) by the child's HLA-DR and SNP profile was estimated. RESULTS: Overall, 65% of mothers reported a life event during pregnancy; disease/injury (25%), serious interpersonal (28%) and job-related (25%) life events were most common. The association of life events during pregnancy differed between IAA and GADA as the first-appearing autoantibody. Serious interpersonal life events correlated with increased risk of GADA-first only in HLA-DR3 children with the BACH2-T allele (HR 2.28, p < 0.0001), an additive interaction (RERI 1.87, p = 0.0004). Job-related life events were also associated with increased risk of GADA-first among HLA-DR3/4 children (HR 1.53, p = 0.04) independent of serious interpersonal life events (HR 1.90, p = 0.002), an additive interaction (RERI 1.19, p = 0.004). Job-related life events correlated with reduced risk of IAA-first (HR 0.55, p = 0.004), particularly in children with the BTNL2-GG allele (HR 0.48; 95% CI 0.31, 0.76). CONCLUSIONS/INTERPRETATION: Specific life events during pregnancy are differentially related to IAA vs GADA as first-appearing IA and interact with different HLA and non-HLA genetic factors, supporting the concept of different endotypes underlying type 1 diabetes. However, the mechanisms underlying these associations remain to be discovered. Life events may be markers for other yet-to-be-identified factors important to the development of first-appearing IA.

Parental monitoring for type 1 diabetes in genetically at-risk young children: The TEDDY study.

OBJECTIVE: We examined parental diabetes monitoring behaviors in a cohort of children at increased genetic risk for type 1 diabetes. We hypothesized that being informed of a positive islet autoantibody (IA) would increase monitoring behaviors. RESEARCH DESIGN AND METHODS: The Environmental Determinants of Diabetes in the Young (TEDDY) study follows 8676 children with high-risk human leucocyte antigen-DQ genotypes from birth to age 15, including general population (GP) children and those with a first-degree relative (FDR) with diabetes. Data on parental monitoring behaviors were solicited yearly. Serum samples were tested for IA and parents were informed of child results. We examined parental monitoring behaviors during the first 7 years of TEDDY. RESULTS: In IA- children, the most common monitoring behavior was participating in TEDDY study tasks; up to 49.8% and 44.2% of mothers and fathers, respectively, reported this. Among FDRs, 7%-10% reported watching for diabetes symptoms and 7%-9% reported monitoring the child's glucose, for mothers and fathers, respectively. After IA+ notification, all monitoring behaviors significantly increased in GP parents; only glucose monitoring increased in FDR parents and these behaviors continued for up to 4 years. FDR status, accurate diabetes risk perception, and anxiety were associated with glucose monitoring in IA+ and IA- cohorts. CONCLUSIONS: Many parents view TEDDY participation as a way to monitor for type 1 diabetes, a benefit of enrollment in a longitudinal study with no prevention offered. IA+ notification increases short- and long-term monitoring behaviors. For IA- and IA+ children, FDR parents engage in glucose monitoring, even when not instructed to do so.

Adherence to oral glucose tolerance testing in children in stage 1 of type 1 diabetes: The TEDDY study.

OBJECTIVE: To examine adherence to the oral glucose tolerance test (OGTT) in multiple islet autoantibody children in stage 1 of developing type 1 diabetes (T1D). METHODS: Children are followed from birth in The Environmental Determinants of Diabetes in the Young (TEDDY) study. Completion of an OGTT is recommended every 6 months in children ≥3 years of age who are multiple islet autoantibody positive. Factors associated with adherence to the OGTT protocol were examined. RESULTS: The average subject level adherence with the OGTT protocol was 62% although there were large differences across countries; Finnish participants and older children from Sweden were more adherent than participants from the United States and Germany. Factors associated with nonadherence included having a first-degree relative with T1D, using a local laboratory rather than a TEDDY center for the OGTT, and maternal underestimation of the child's risk for T1D. Children were more adherent to the OGTT if their mothers: were more satisfied with TEDDY participation, reported monitoring the child for T1D by checking blood glucose levels at home, and viewed participating in TEDDY as the primary way they were monitoring the child for T1D. CONCLUSIONS: In a study of children in stage 1 of T1D, adherence to an OGTT protocol was suboptimal despite extensive efforts to communicate the child's high risk to parents. These findings provide important guidance for development of strategies to improve methods for detecting progression or the development of T1D in high-risk pediatric populations.

Blood Glucose Monitoring Before and After Type 1 Diabetes Clinic Visits.

Objective: To determine patterns of blood glucose monitoring in children and adolescents with type 1 diabetes (T1D) before and after routine T1D clinic visits. Methods: Blood glucose monitoring data were downloaded at four consecutive routine clinic visits from children and adolescents aged 5-18 years. Linear mixed models were used to analyze patterns of blood glucose monitoring in patients who had at least 28 days of data stored in their blood glucose monitors. Results: In general, the frequency of blood glucose monitoring decreased across visits, and younger children engaged in more frequent blood glucose monitoring. Blood glucose monitoring increased before the T1D clinic visits in younger children, but not in adolescents. It declined after the visit regardless of age. Conclusions: Members of the T1D care team need to consider that a T1D clinic visit may prompt an increase in blood glucose monitoring when making treatment changes and recommendations. Tailored interventions are needed to maintain that higher level of adherence across time.

Family adjustment to diabetes diagnosis in children: Can participation in a study on type 1 diabetes genetic risk be helpful?

BACKGROUND: Diagnosis of type 1 diabetes often causes a negative psychological impact on families. We examined whether parents and children enrolled in The Environmental Determinants of Diabetes in the Young (TEDDY) study differ in their psychological adjustment to diabetes diagnosis compared to children diagnosed with diabetes in the community. METHODS: TEDDY follows 8676 children at genetic risk for type 1 diabetes from birth. Fifty-four TEDDY children diagnosed with diabetes and 54 age-matched community control children diagnosed with diabetes were enrolled. Participants were aged 3 to 10 years and study visits occurred at 3, 6, and 12 months postdiagnosis. Psychological measures included an adapted diabetes-specific State Anxiety Inventory, the Pediatric Quality of Life Inventory-Diabetes Module, and the Pediatric Inventory for Parents, which measures frequency and difficulty of parenting stress. RESULTS: A generalized estimating equation analysis based on a difference score between TEDDY children and community controls found no significant differences between TEDDY parents and community controls on parent diabetes-specific anxiety (P = .30). However, TEDDY children exhibited better diabetes-specific quality of life (P = .03) and TEDDY parents reported lower frequency (P = .004) and difficulty (P = .008) of parenting stress compared to community controls. CONCLUSIONS: Children diagnosed with at-risk for type 1 diabetes who have previously enrolled in research monitoring have improved diabetes quality of life and lower parenting stress postdiagnosis compared to children diagnosed in the community. Families in follow-up studies may be more prepared if their child is diagnosed with diabetes.

The feasibility of salivary sample collection in an international pediatric cohort: The the TEDDY study.

Saliva offers a relatively noninvasive method for measuring analytes such as cortisol, holding particular promise for use in pediatric populations on a large scale if a rigorous collection protocol is feasible in diverse settings. The Environmental Determinants of Diabetes in the Young study protocol, conducted in centers in the United States, Sweden, Finland, and Germany, used salivary collection to assess cortisol level as a physiologic marker of stress. Saliva was collected using Sorbettes from subjects at 3.5, 4.5, and 5.5 years of age. Parents collected a morning sample, and staff collected pre- and post-blood draw samples. Feasibility was assessed based on protocol completion, adherence with instructions, factors affecting adherence, and sufficiency of saliva sample for cortisol determination. Collection of saliva samples in a diverse pediatric population is feasible. Establishing non-invasive and acceptable methods for collecting physiological parameters of stress will allow better exploration of determinants of health in this important population.

Predicting Later Study Withdrawal in Participants Active in a Longitudinal Birth Cohort Study for 1 Year: The TEDDY Study.

OBJECTIVE: To identify predictors of later study withdrawal among participants active in The Environmental Determinants of Diabetes in the Young (TEDDY) for 1 year. METHODS: Multiple logistic regression was used to discriminate 3,042 children active in TEDDY for the first 3 years from 432 children who withdrew in Years 2 or 3. Predictor variables were tested in blocks-demographic, maternal lifestyle behaviors, stress and child illness, maternal reactions to child's increased diabetes risk, in-study behaviors-and a final best model developed. RESULTS: Few demographic factors predicted study withdrawal. Maternal lifestyle behaviors, accuracy of the mother's risk perception, and in-study behaviors were more important. Frequent child illnesses were associated with greater study retention. CONCLUSIONS: Demographic measures are insufficient predictors of later study withdrawal among those active in a study for at least 1 year; behavioral/psychological factors offer improved prediction and guidance for the development of retention strategies.

Structures and Strategies for Retaining an International Pediatric Cohort from Birth: Lessons from The Environmental Determinants of Diabetes in the Young (TEDDY) Study.

Background: Retention of study participants in observational studies is essential to maintaining the representativeness of the population, minimizing selection bias, and assuring sufficient statistical power. The aim of this report is to describe the structures and strategies used to retain participants in The Environmental Determinants of Diabetes in the Young (TEDDY) Study, an observational study of children at increased genetic risk for type 1 diabetes followed in an intense protocol with frequent clinic visits from birth until age 15. Methods: A systematic review of methodologies used to retain research subjects identified four domains: barrier reduction strategies; community building strategies; follow-up/reminder strategies; and tracing strategies. Independent reviewers categorized the retention strategies implemented by the TEDDY Study into each of these domains. Strategies not fitting into any of these categories were placed into a fifth category unique to TEDDY. Results: TEDDY identified over one hundred retention strategies used during the 15 years of follow-up; most could be categorized in these domains. Those unique to TEDDY included (1) study organization and structures to support retention; (2) efforts to meet the changing developmental needs of the TEDDY population, (3) implementation of efforts to address protocol challenges in real-time; and (4) employment of a re-engagement protocol for those who had dropped out of the study. Conclusion: Pediatric cohort studies should include strategies, structures, and resources addressing retention at the study's initiation. It is recommended that child and parent engagement in addition to the developmental needs of the child be an integrated focus of all strategies. Putting mechanisms in place to address protocol and retention challenges in real time would facilitate effectively addressing challenges as they arise. Trial registration: ClinicalTrials.gov Identifier: NCT00279318.

Psychometric properties of the Pediatric Testing Attitudes Scale-Diabetes (P-TAS-D) for parents of children undergoing predictive risk screening.

OBJECTIVE: Examine the factor structure, reliability, and validity of the Pediatric Testing Attitudes Scale-Diabetes (P-TAS-D), a measure of parental attitudes about predictive risk screening for type 1 diabetes in children. METHODS: Surveys were completed by 3720 Swedish parents of children participating in the adolescent follow-up of a birth cohort study of type 1 diabetes onset. Parents averaged 43.5 years, 42.3% were college-educated, and 10.6% of children had a family history of type 1 diabetes. The parent sample was randomly divided, an exploratory factor analysis (EFA; n = 1860) was conducted, followed by confirmatory factor analysis (CFA; n = 1860) and testing. RESULTS: EFA/CFA revealed the P-TAS-D has three factors/scales: Attitudes and Beliefs toward type 1 diabetes predictive risk screening (α = 0.92), Communication about risk screening results (α = 0.71), and Decision Making (r = 0.19, p < 0.001). This solution fit the data well (χ(2) [42] = 536.0, RMSEA = 0.08, CFI = 0.95) and internal consistency for the full scale was high (α = 0.86, M = 36.2, SD = 8.2). After adjusting for covariates, more favorable attitudes toward children's risk screening were associated with greater worry about type 1 diabetes (B = 1.1, p < 0.001), less worry about health overall (B = -0.10, p = 0.001), and more positive attitudes toward (B = 0.28, p < 0.001) and less worry about (B = 0.41, p < 0.001) diabetes research. CONCLUSIONS: The P-TAS-D is a stable, reliable, and valid measure for assessing parents' type 1 diabetes risk screening attitudes. Scale data can help target parent education efforts in risk screening trials.

A Community Health Center Childhood Obesity Program for Latino Families from an Agricultural Community: Mental Health and Physical Activity Outcomes.

The purpose of this study was to evaluate the impact of an ongoing multidisciplinary childhood obesity intervention, within a federally qualified health center, on mental health and physical activity outcomes with Latino children from an agricultural community. The program was evaluated using attendance and parent-reports of child mental health and physical activity levels. Paired t-tests and chi squared tests were used to examine pre-post change in outcomes. There were 100 total participants. The mean age was 9.40 years, and the mean BMI percentile was 97.39. Significant post-intervention improvements were observed in mental health externalizing and internalizing problems (p <.0001) and in weekly physical activity frequency (p =.0131) and duration (p = .0280). Childhood obesity interventions should target mental health problems as well as obesity as the two are closely related. Community health centers may be ideal settings for interventions as they can facilitate access to needed services for high-risk populations.

Factors assessed in the first year of a longitudinal study predict subsequent study visit compliance: the TEDDY study.

BACKGROUND: Compliance with a study protocol is central to meeting its research goals. In longitudinal research studies, data loss due to missed visits limit statistical power and introduce bias. The Environmental Determinants of Diabetes in the Young (TEDDY) study is a longitudinal multinational (US, Finland, Germany, and Sweden) investigation of children at risk for type 1 diabetes (T1D) that seeks to identify the environmental triggers of islet autoimmunity and T1D. The purpose of the current study was to identify sociodemographic variables and maternal characteristics assessed in the first year of TEDDY that were associated with study visit compliance in the subsequent 3 years. METHODS: Sociodemographic variables, maternal life-style behaviors, post-partum depression, maternal reactions to the child's T1D risk, and study-related variables were collected at child-age 6 months and 15 months. Multiple linear regression was used to examine the association of these variables to study visit compliance in the subsequent 3 years. RESULTS: Study visit compliance was highest in Sweden (p > 0.001), in children who were their mother's first child (p > 0.001), and whose mothers were older (p > 0.001) and more satisfied with the TEDDY study (p > 0.001). Father participation was also associated with better study visit compliance (p > 0.001). In contrast, children whose mothers smoked (p > 0.001), suffered from post-partum depression (p = 0.034), and were more anxious about their child's T1D risk (p = 0.002), completed fewer visits. Father's study satisfaction was also associated with study visit compliance (p = 0.029); however, it was not significant in models that included maternal study satisfaction. CONCLUSIONS: Sociodemographic variables, maternal characteristics-including study satisfaction-and fathers' participation in the first year of a longitudinal study were associated with subsequent study visit compliance in a sample of children genetically at-risk for T1D followed for 4 years. This information can inform future strategies designed to improve study visit compliance in longitudinal pediatric studies. TRIAL REGISTRATION: NCT00279318, 06/09/2004.

Physical Activity and the Development of Islet Autoimmunity and Type 1 Diabetes in 5- to 15-Year-Old Children Followed in the TEDDY Study.

OBJECTIVE: This study investigated physical activity and its association with the development of islet autoimmunity and type 1 diabetes in genetically at-risk children aged 5-15 years. RESEARCH DESIGN AND METHODS: As part of the longitudinal Environmental Determinants of Diabetes in the Young (TEDDY) study, annual assessment of activity using accelerometry was conducted from age 5 years. Time-to-event analyses using Cox proportional hazard models were used to assess the association between time spent in moderate to vigorous physical activity per day and the appearance of one or several autoantibodies and progression to type 1 diabetes in three risk groups: 1) 3,869 islet autoantibody (IA)-negative children, of whom 157 became single IA positive; 2) 302 single IA-positive children, of whom 73 became multiple IA positive; and 3) 294 multiple IA-positive children, of whom 148 developed type 1 diabetes. RESULTS: No significant association was found in risk group 1 or risk group 2. A significant association was seen in risk group 3 (hazard ratio 0.920 [95% CI 0.856, 0.988] per 10-min increase; P = 0.021), particularly when glutamate decarboxylase autoantibody was the first autoantibody (hazard ratio 0.883 [95% CI 0.783, 0.996] per 10-min increase; P = 0.043). CONCLUSIONS: More daily minutes spent in moderate to vigorous physical activity was associated with a reduced risk of progression to type 1 diabetes in children aged 5-15 years who had developed multiple IAs.

Addressing Childhood Obesity among Latino Agricultural Families: Data from a Feasibility Study at a Community Health Center.

The purpose of this study was to evaluate the feasibility of a family childhood obesity program for Latino agricultural families within a community health center. The program included several treatment components to address culturally relevant topics and other factors, such as poverty, that affect agricultural workers. The program was evaluated using attendance, height, and weight data. Linear mixed models were used to analyze weight data, including measurements obtained before, during, and after the intervention. A total of 133 subjects participated. Attendance was significantly associated with greater weight loss. Younger children exhibited a significant decline in weight during the intervention whereas older children did not experience any weight improvements. Community health centers may provide the appropriate infrastructure for multidisciplinary childhood obesity interventions targeting young Latino children from agricultural families. Additional research is needed to understand the treatment needs of Latino adolescents.

Bring Blood Glucose Down! An intervention to reduce fear of hypoglycemia in caregivers of adolescents with type 1 diabetes: Study design and participant characteristics.

Fear of hypoglycemia (FOH) is anxiety or extreme worry about having a low blood glucose and its consequences. FOH is common in individuals with type 1 diabetes (T1D) of all ages, as well as their caregivers, and can lead to inappropriate T1D self-management and suboptimal health outcomes. Despite its prevalence and serious health consequences, there has been very little attention focused on developing interventions to reduce FOH and its associated maladaptive T1D management behaviors. The primary aim of the present study, Bring BG Down!, was to implement a pilot intervention targeting FOH in mothers of adolescents with T1D. Exploratory aims included determining if the intervention had an impact on the adolescent's FOH, glycemia, as well as other generalized anxiety symptoms or symptoms of obsessive-compulsive disorder in both the mother and adolescent. Caregiver participants and their adolescents with T1D were randomized to either the Bring BG Down! group or the Control group. Individuals in the Bring BG Down! group participated in intervention sessions for 6 months via telehealth and they completed questionnaires, whereas those in the Control group only completed questionnaires. Follow-up occurred at 7-months and 10-months. The purpose of this paper is to describe the Bring BG Down! study design and rationale, and participant characteristics at the start of the study.

Psychological impact of screening and prediction in type 1 diabetes.

Screening programs designed to identify persons at risk for type 1 diabetes via genetic and antibody testing are controversial because they typically target children, provide only a crude estimate of type 1 diabetes risk, and offer no means of preventing the disease. For this reason, genetic and antibody testing for type 1 diabetes risk is usually limited to carefully conducted research studies. The psychological impact of such screening programs include cognitive, emotional, and behavioral sequelae; the available literature has focused primarily on parents, and usually mothers, since the target of screening is usually infants or young children. Diabetes risk is a difficult construct to effectively communicate. Many individuals fail to accurately understand risk; inaccurate risk perceptions may increase over time and have been associated with early study withdrawal. Simply asking study participants if they understand the risk information provided is insufficient. Anxiety and worry are common reactions to learning that you or a loved one is at increased risk for type 1 diabetes. For most people, anxiety and worry dissipate with time but some individuals may be particularly vulnerable to prolonged anxiety or depression. Although there is no known means to prevent type 1 diabetes in at-risk individuals, families often report increased surveillance of those at risk and behavior changes to prevent the disease, potentially threatening the internal validity of the study.

The Environmental Determinants of Diabetes in the Young (TEDDY) study: predictors of early study withdrawal among participants with no family history of type 1 diabetes.

OBJECTIVE: The Environmental Determinants of Diabetes in the Young (TEDDY) study seeks to identify environmental triggers of autoimmunity and type 1 diabetes mellitus (T1DM) in children at increased human-leukocyte-antigen conferred genetic risk for this disease. The objective of this study was to identify predictors of early withdrawal from TEDDY among families with no immediate family history of T1DM. METHOD: Logistic multiple regression was used to discriminate 2994 (83%) families currently active in the TEDDY study for ≥1 yr from 763 (17%) families who withdrew in the first year. Data collected on the screening form at the time of the child's birth and from interview and questionnaire data obtained at the baby's first study visit (at ≤4.5 months of age) were used. RESULTS: Significant and independent predictors of early withdrawal included country of residence, young maternal age, no father participation, and female gender of the study participant. Mothers of children who withdrew were more likely to report smoking during pregnancy, abstaining from alcohol, and reducing their work hours or not working at all during pregnancy. Mothers who withdrew were also more likely to underestimate their child's risk for T1DM and fail to respond to multiple items on the enrollment questionnaires or interview. Among mothers with accurate risk perceptions, those experiencing high anxiety about their child's risk were more likely to be early withdrawals. CONCLUSIONS: Identifying families at high risk for study withdrawal at the time of enrollment allows for targeting these families with individually tailored plans to help maintain their participation in the study.