School Nurses' Comfort With Diabetes Management and Technology From 2012 to 2019.

Objective: School nurses are integral to optimizing diabetes management for students with type 1 diabetes. The aim of this study was to describe the use of diabetes technology in schools over time and assess school nurses' comfort level performing diabetes management tasks. Study design: From 2012 to 2019, school nurses who attended a diabetes education program completed a survey about their experience and comfort level with diabetes management. Results: A total of 1,796 school nurses completed the survey; 56% had at least 5 years of school nursing experience. Most (86%) had at least one student with type 1 diabetes. Among school nurses with at least one student with type 1 diabetes, 73% had at least one student using insulin pump therapy, and 48% had at least one student using continuous glucose monitoring (CGM). There was no change in pump use over time, but the percentage of nurses who had a student using CGM increased significantly from 24% in 2012 to 86% in 2019 (P <0.001). School nurses' comfort level using pumps remained stable over time. Overall, 47% reported being mostly/very comfortable giving boluses using a pump, and 17% reported being mostly/very comfortable troubleshooting problems with a pump. However, there was a significant increase in school nurses reporting feeling mostly/very comfortable working with CGM devices, increasing from 9% in 2012 to 44% in 2019 (P <0.001). Conclusion: School nurses are an important part of diabetes management for school-aged youth with type 1 diabetes. There is a need for additional diabetes education and support to build their confidence with diabetes management and technology, especially with further technological advancements in management.

Adherence to multiple medications in the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) cohort: effect of additional medications on adherence to primary diabetes medication.

Background Non-adherence to diabetes medication leads to poor outcomes and increased healthcare costs. Multiple factors affecting adherence in adults with type 2 diabetes (T2D) have been identified, but pediatric data is sparse. We aimed to determine whether initiation of additional oral medications or insulin affects adherence to primary study medication (PSM) in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. Methods Six hundred and ninety-nine youth (aged 10-17 years) with recent-onset T2D were randomized in the TODAY study. Participants were categorized as adherent (≥80% taken by pill count) or non-adherent (<80%), and adherence was compared between those on additional medications or not. Subgroup analyses to assess influence of race/ethnicity, gender, medication type, or depression were performed. Results At 36 months, 46.3% of participants were taking additional oral medications and 31.9% were on insulin. There was no difference in study medication adherence with additional oral medications (55.1%, 67.1%, and 56.7% at month 36 in those prescribed 0, 1, or 2+ additional medications; p = 0.16). Girls on oral contraceptives (OC) had higher adherence (65.2% vs. 55.8% at month 36; p = 0.0054). Participants on insulin had lower adherence (39.7% vs. 59.3% at 36 months; p < 0.0001). There was decreased adherence in participants with baseline depression (p = 0.008). Conclusions Additional oral medications did not influence adherence to diabetes medications in TODAY. Addition of insulin led to reduced adherence. In subgroup analyses, OC use was associated with higher adherence in girls, while baseline depression was associated with lower adherence overall. Further studies examining potentially modifiable risk factors of adherence in pediatric T2D are needed.

Correlates of Medication Adherence in the TODAY Cohort of Youth With Type 2 Diabetes.

OBJECTIVE: To identify factors that predict medication adherence and to examine relationships among adherence, glycemic control, and indices of insulin action in TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth). RESEARCH DESIGN AND METHODS: A total of 699 youth 10-17 years old with recent-onset type 2 diabetes and ≥80% adherence to metformin therapy for ≥8 weeks during a run-in period were randomized to receive one of three treatments. Participants took two study pills twice daily. Adherence was calculated by pill count from blister packs returned at visits. High adherence was defined as taking ≥80% of medication; low adherence was defined as taking <80% of medication. Depressive symptoms, insulin sensitivity (1/fasting insulin), insulinogenic index, and oral disposition index (oDI) were measured. Survival analysis examined the relationship between medication adherence and loss of glycemic control. Generalized linear mixed models analyzed trends in adherence over time. RESULTS: In this low socioeconomic cohort, high and low adherence did not differ by sex, age, family income, parental education, or treatment group. Adherence declined over time (72% high adherence at 2 months, 56% adherence at 48 months, P < 0.0001). A greater percentage of participants with low adherence had clinically significant depressive symptoms at baseline (18% vs. 12%, P = 0.0415). No adherence threshold predicted the loss of glycemic control. Longitudinally, participants with high adherence had significantly greater insulin sensitivity and oDI than those with low adherence. CONCLUSIONS: In the cohort, the presence of baseline clinically significant depressive symptoms was associated with subsequent lower adherence. Medication adherence was positively associated with insulin sensitivity and oDI, but, because of disease progression, adherence did not predict long-term treatment success.

Improving dietary quality in youth with type 1 diabetes: randomized clinical trial of a family-based behavioral intervention.

BACKGROUND: Diets of children with type 1 diabetes are low in fruits, vegetables, and whole grains, and high in foods of minimal nutritional value, increasing risk for future adverse health outcomes. This 18-month randomized clinical trial tested the effect of a family-based behavioral intervention integrating motivational interviewing, active learning, and applied problem-solving on the primary outcomes of dietary intake and glycemic control among youth with type 1 diabetes. METHODS: A parallel-group study with equal randomization was conducted at an outpatient, free-standing, multidisciplinary tertiary diabetes center in the United States. Eligible youth were those age 8-16 years with type 1 diabetes diagnosis ≥1 year and hemoglobin A1c (HbA1c) ≥6.5% and ≤10.0%. Participants were 136 parent-youth dyads (treatment n = 66, control n = 70). The intervention consisted of 9 in-clinic sessions delivered to the child and parent; control condition comprised equivalent assessments and number of contacts without dietary advice. Dietary intake was assessed using 3-day diet records at 6 time points across the 18-month study. Dietary outcomes included the Healthy Eating Index-2005 (HEI2005; index measuring conformance to the 2005 United States Dietary Guidelines for Americans) and Whole Plant Food Density (WPFD; number of cup or ounce equivalents per 1000 kcal of whole grains, whole fruit, vegetables, legumes, nuts, and seeds consumed). HbA1c was obtained every 3 months. Overall comparison of outcome variables between intervention and usual care groups was conducted using permutation tests. RESULTS: There was a positive intervention effect across the study duration for HEI2005 (p = .015) and WPFD (p = .004). At 18 months, HEI2005 was 7.2 greater (mean ± SE 64.6 ± 2.0 versus 57.4 ± 1.6), and WPFD was 0.5 greater (2.2 ± 0.1 versus 1.7 ± 0.1) in the intervention group versus control. There was no difference between groups in HbA1c across the study duration. CONCLUSIONS: This behavioral nutrition intervention improved dietary quality among youth with type 1 diabetes, but did not impact glycemic control. Findings indicate the potential utility of incorporating such strategies into clinical care, and suggest that improvement in diet quality can be achieved in families living with this burdensome disease. TRIAL REGISTRATION: Clinicaltrials.gov registration number: NCT00999375.

Associations of youth and parent weight status with reported versus predicted daily energy intake and hemoglobin A1c in youth with type 1 diabetes mellitus.

BACKGROUND: The epidemic of overweight/obesity affects youth with type 1 diabetes mellitus (T1DM) and their families. In youth with T1DM and their parents, we examined weight status with reported and expected energy intake and with youth hemoglobin A1c (HbA1c). METHODS: In 243 youth (48% female, 13 ± 3 years) and their parents (84% female, 45 ± 6 years), we assessed body mass index (BMI), prevalence of overweight/obesity, reported energy intake (REI), and youth glycemic control (HbA1c). The REI was compared with predicted daily energy requirements (DER; based on age, weight, sex, and physical activity). RESULTS: Youth had diabetes duration of 6.3 ± 3.4 years and HbA1c of 8.5% ± 1.3%; 69% used insulin pump therapy. Overweight and obesity affected 23% and 11% of youth and 30% and 24% of parents, respectively. Youth and parent BMI (r = 0.38; p < .001) and weight status (overweight/obese; p < .001) were significantly associated. The ratio of REI:DER was significantly lower in overweight/obese compared with underweight/normal weight parents (1.0 ± 0.4 versus 1.2 ± 0.5; p = .001) but did not differ among youth by weight status. Both youth and parent BMI were positively correlated with youth HbA1c (r = 0.14, p = .02; r = 0.16, p = .01, respectively). Hemoglobin A1c tended to be higher in obese than in overweight and normal weight youth (mean ± standard deviation [SD] 8.4 ± 1.4, 8.4 ± 1.3, and 8.8 ± 1.0, respectively; p = .06) and was significantly higher in youth whose parents were obese versus overweight or underweight/normal weight (mean ± SD 8.2 ± 1.2, 8.5 ± 1.4, and 8.9 ± 1.5, respectively; p < .001). CONCLUSIONS: Similar to the general population, overweight and obesity are prevalent among families of youth with T1DM. Weight status appears to influence self-REI in parents and glycemic control in youth with T1DM, suggesting the need for family-based dietary interventions.

Development and validation of the type 1 diabetes nutrition knowledge survey.

OBJECTIVE: The purpose of this study was to develop a survey of general and diabetes-specific nutrition knowledge for youth with type 1 diabetes and their parents and to assess the survey's psychometric properties. RESEARCH DESIGN AND METHODS: A multidisciplinary pediatric team developed the Nutrition Knowledge Survey (NKS) and administered it to youth with type 1 diabetes (n = 282, 49% females, 13.3 ± 2.9 years) and their parents (82% mothers). The NKS content domains included healthful eating, carbohydrate counting, blood glucose response to foods, and nutrition label reading. Higher NKS scores reflect greater nutrition knowledge (score range is 0-100%). In youths, glycemic control was assessed by A1C, and dietary quality was determined by the Healthy Eating Index-2005 (HEI-2005) derived from 3-day diet records. Validity was based on associations of NKS scores with A1C and dietary quality. Reliability was assessed using the Kuder-Richardson Formula 20 (KR-20) and correlations of domain scores to total score. RESULTS: Mean NKS scores (23 items) were 56.9 ± 16.4% for youth and 73.4 ± 12.5% for parents. The KR-20 was 0.70 for youth and 0.59 for parents, representing acceptable internal consistency of the measure. In multivariate analysis, controlling for youth age, family income, parent education, diabetes duration, and insulin regimen, parent NKS scores were associated with corresponding youth A1C (ß = -0.13, P = 0.03). Both parent (ß = 0.20, P = 0.002) and youth (ß = 0.25, P < 0.001) NKS scores were positively associated with youth HEI-2005 scores. CONCLUSIONS: The NKS appears to be a useful measure of general and diabetes-specific nutrition knowledge for youth with type 1 diabetes and their parents.

Metformin monotherapy in youth with recent onset type 2 diabetes: experience from the prerandomization run-in phase of the TODAY study.

BACKGROUND: TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) is a federally funded multicenter randomized clinical trial comparing three treatments of youth onset type 2 diabetes. OBJECTIVE: To describe the experience of youth participating in a 2-6 month run-in period in preparation for randomization into TODAY. SUBJECTS: An ethnically diverse sample of 927 youth, 65.4% females, aged 13.7 ± 2.0 yr old, with type 2 diabetes for a median of 2 months (0.7-7.8 months, 25th-75th percentiles). METHODS: A run-in period was conducted to achieve HbA1c <8% with metformin monotherapy and diabetes education, and to evaluate adherence to pill taking, visit attendance, and other procedures. RESULTS: At entry, mean body mass index (BMI) and z-BMI were 35.6 ± 7.7 and 2.3 ± 0.4, respectively, mean HbA1c was 7.7 ± 2.2%, only 42.5% were on a hypoglycemic treatment, and 35.6% had HbA1c ≥8%. Comorbid conditions were common; 18.8% had hypertension, 24.2% had elevated cholesterol, and 6.5% had abnormal liver enzymes. After a median 71 d of run-in, 90.9% had HbA1c <8%, 77.9% had HbA1c <7%, and 46.4% had HbA1c <6%. Of the 772 youth achieving the target HbA1c <8%, 704 (91.2%) were randomized; non-adherence to metformin treatment was the main cause for non-randomization. Youth proceeding to randomization decreased weight by 0.68 kg and HbA1c by 1.45% compared to a weight gain of 0.71 kg and HbA1c decrease of 0.74% in the non-randomized youth (p = 0.01 in both cases). However, change in z-BMI was not significantly different between the two groups. CONCLUSIONS: Most youth with recent onset type 2 diabetes can achieve target HbA1c <8.0% with short-term metformin monotherapy and standard diabetes education (ClinicalTrials.gov identifier: NCT00081328).

Collaborative Staffing Model for Multiple Sites: Reducing the challenges of study coordination in complex, multi-site clinical trials.

The implementation of complex, multi-site clinical trials presents challenges that make recruitment efforts, participant follow-up, and organization of staff critical to the success of the overall outcome. This article describes a unique staffing model utilized by the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) study, an NIH (National Institutes of Health) sponsored trial designed to explore treatment options for type 2 diabetes in youth. At each study center, the program coordinator (PC) and diabetes educator (DE) work together to implement the study protocol. A staffing model that provides this type of mutual support for two key members of the study team may decrease the burden customarily encountered solely by the PC in complex trials, and furthermore allows for cross-coverage and flexibility. To determine the degree of overlap and task sharing between the PC and DE across study sites, a self-administered survey was distributed to all PCs and DEs. Survey results as well as specific examples demonstrating an effective collaborative approach by front-line study personnel in managing various challenges encountered in study implementation are included.

Emphasis on carbohydrates may negatively influence dietary patterns in youth with type 1 diabetes.

OBJECTIVE: To assess perceptions of healthful eating and the influence of diabetes management on dietary behaviors among youth with type 1 diabetes and parents. RESEARCH DESIGN AND METHODS: Youth with type 1 diabetes (n = 35), ages 8-21 years, and parents participated in focus groups. Focus group recordings were transcribed and coded into themes. Clinical data were abstracted from the electronic medical record. RESULTS: Central topics were perceptions of healthful eating and the impact of diabetes management on diet. An emphasis on limiting postprandial glycemic excursions occasionally contradicted the traditional perception of healthful eating, which emphasized consumption of nutrient-dense whole foods in favor of prepackaged choices. Whereas fixed regimens required more rigid diets, basal-bolus regimens provided more opportunities for unhealthful eating. Most youth perceived "refined" grains as more healthful grains. CONCLUSIONS: For youth with type 1 diabetes and parents, an emphasis on carbohydrate quantity over quality may distort beliefs and behaviors regarding healthful eating.

Nutritional Management of the overweight child with type 2 diabetes.

In light of the strong association between excess weight and type 2 diabetes, the nutritional management of the child with type 2 diabetes often focuses on changing dietary and physical activity habits to normalize weight, instill long-term healthy habits, and provide glycemic control. A multidisciplinary approach to the treatment of childhood obesity should include the child's family and caregivers to be most effective. Weight goals in children should be based on the age of the child, the extent of overweight, and the presence of complications. Likewise, physical activity is an important component of treatment and should be titrated to the child's age, ability and overweight status. Efforts to avoid the development of obesity, and potentially type 2 diabetes, should be started early in the child's life. Education and fostering a healthy lifestyle during childhood is the best defense to slow down or reverse the obesity epidemic in our society that is now affecting even the youngest of children, setting them up for potentially life-threatening diseases in the future.