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Background: Past research has demonstrated that adolescents with Type 1 diabetes (T1D) typically have a decline in health outcomes as they begin to assume more self-management activities. Mobile app interventions have been suggested as one possible way to improve this behavior. Purpose: The primary aim of this study was to address declines in health outcomes by pilot testing the satisfaction, use and feasibility of an app-based family communication intervention aimed to assist in adolescent self-management of T1D. Methods: Thirty-three adolescent–parent pairs were enrolled in and completed the 12-week pilot study. Participants were randomized 2:1 to intervention (app use) or control group. Pre/post quantitative and qualitative data were collected, including HbA1c and surveys. Paired-sample t -tests and ANOVA statistics were conducted. Results: The parents and adolescents reported high satisfaction with the app, and that it was easy to use. Results showed HbA1c stability in the intervention group and significant worsening in the control group. There were also significant improvements in adherence to diabetes management and quality of life for the parents in the intervention group. The adolescents did not show any improvement in quality-of-life measures. Conclusion: This study suggests that the app intervention is acceptable, shows promise for improving health outcomes for adolescents with T1D, and may improve family communication. The public health implications of this work are that app interventions have a potential role in positively influencing chronic disease outcomes. Additional research with a more extensive and diverse sample is needed to determine generalizability. [ABSTRACT FROM AUTHOR]

Effectively caring for a child with type-1 diabetes (T1D) can be extremely demanding and stressful for the entire family. The difficulties of caring for a child with T1D impact the psychological and physical well-being of the parents. Interventions aimed at reducing stress and increasing coping may improve parental outcomes. This project sought to develop a resource to be used as a preliminary intervention step for these parents. This research was conducted in two parts. Part 1 includes three stages of formative evaluation, including a focus group, interviews, and a survey with parents to examine the current landscape of diabetes websites as a resource. Using data from Part 1, Part 2 of the study included the identification of a theory to guide the design of a website, the development of the website, and an 8-week pilot study of the website with parents with a child with T1D. Significant improvements were found in diabetes knowledge and caregivers' satisfaction of life. No changes were found in social support, self-efficacy, or quality of life. Overall, the data show that the parents were generally satisfied with the website. Through this work, researchers were able to develop a deeper understanding of the needs of parents caring for a child with T1D to develop the initial component of a larger intervention. [ABSTRACT FROM AUTHOR]

Introduction: Type 1 diabetes impacts approximately 1.25 m Americans, many of them young children. As a child grows, there is a transition towards independence and they must learn to manage their diabetes independently. The objective of this study was to design, develop and conduct a prototype test to assess the satisfaction and feasibility of a mobile app for adolescents with type 1 diabetes and their parents to aid in this transition.Methods: Ten parent/adolescent groups used MyT1DHero for four weeks. They were given a pre-test/post-test survey regarding family conflict with three tasks of diabetes management and the general tone of family communication. At post-test they were asked questions regarding their satisfaction and perception of ease of use of the app. They also participated in short interviews regarding the app. Additionally, we used server data to examine actual app usage.Results: The parents' perceptions of conflict around the results of the blood sugar tests increased ( t(9) = 2.71, p = .02) as did perceptions of conflict around logging the blood sugar results ( t(9) = 3.67, p = .005). The adolescents perceived increased conflict surrounding the results around logging the blood sugars results ( t(9) = 3.09, p = .01).There was no change in the tone of general family communication. During the prototype testing, we discovered that the app crashed repeatedly and several of the functions were not working properly. In the interview data, three main themes emerged, app-crashing issues, problems with notifications and positive feedback.Discussion: Through this process, all of the reported issues were corrected and new features were planned for subsequent versions. A smartphone application has the potential to be a novel intervention for engaging adolescents and their parents in positive communication to support type 1 diabetes management. [ABSTRACT FROM AUTHOR]

Background: The Medtronic predictive low-glucose management (PLGM) algorithm automatically stops insulin delivery when sensor glucose (SG) is predicted to reach or fall below a preset low-glucose value within the next 30 min, and resumes delivery after hypoglycemia recovery. The present study evaluated the PLGM algorithm performance of the MiniMed™ 670G system SmartGuard™ "suspend before low" feature in children aged 7-13 years with type 1 diabetes (T1D).Method: Participants (N = 105, mean ± standard deviation of 10.8 ± 1.8 years) underwent an overnight in-clinic evaluation of the "suspend before low" feature with a preset low limit of 65 mg/dL. After exercise, frequent sample testing (FST) was conducted every 5 min if values were <70 mg/dL; every 15 min if 70-80 mg/dL; and every 30 min if >80 mg/dL. First-day performance of the Guardian™ Sensor 3 glucose sensor and continuous glucose monitoring system was also evaluated.Results: Activation of the "suspend before low" feature occurred in 79 of the 105 participants, 79.7% (63/79) did not result in SG falling below 65 mg/dL. Mean glucose at activation was 102 ± 19 mg/dL and the initial insulin suspension duration was 87.5 ± 32.7 min. Four hours after insulin resumption, mean reference glucose was 130 ± 42 mg/dL. Mean absolute relative difference between the FST reference glucose and SG values on the first day of sensor wear was 11.4%. For the 26 participants in whom the "suspend before low" feature did not activate, none involved a reference glucose value ≤65 mg/dL, suggesting that the PLGM algorithm performed as intended.Conclusion: In children aged 7-13 years with T1D, the "suspend before low" feature of the MiniMed 670G system demonstrated a hypoglycemia prevention rate of nearly 80% after exercise and did not involve rebound hyperglycemia. There were no events of severe hypoglycemia during the evaluation. [ABSTRACT FROM AUTHOR]

A closed loop system of diabetes control would minimize hyperglycemia and hypoglycemia. We therefore implanted and tested a subcutaneous amperometric glucose sensor array in alloxan-diabetic rats. Each array employed four sensing units, the outputs of which were processed in real time to yield a unified signal. We utilized a gain-scheduled insulin control algorithm which rapidly reduced insulin delivery as glucose concentration declined. Such a system was generally effective in controlling glycemia and the degree of lag between blood glucose and the sensor signal was usually 3-8 min. After prolonged implantation, this lag was sometimes longer, which led to impairment of sensor accuracy. Using a prospective two-point calibration method, sensor accuracy and closed loop control were good. A revised algorithm yielded better glycemic control than the initial algorithm did. Future research needs to further improve calibration methods and reduce foreign body fibrosis in order to avoid a time-related increase in lag duration. [ABSTRACT FROM AUTHOR]

Slover RH, Welsh JB, Criego A, Weinzimer SA, Willi SM, Wood MA, Tamborlane WV. Effectiveness of sensor-augmented pump therapy in children and adolescents with type 1 diabetes in the STAR 3 study. Objective: Maintenance of appropriate A1C values and minimization of hyperglycemic excursions are difficult for many pediatric patients with type 1 diabetes. Continuous glucose monitoring (CGM) sensor-augmented pump (SAP) therapy is an alternative to multiple daily injection (MDI) therapy in this population. Research design and methods: Sensor-augmented pump therapy for A1C reduction (STAR 3) was a 1-yr trial that included 82 children (aged 7-12) and 74 adolescents (aged 13-18) with A1C values ranging from 7.4 to 9.5% who were randomized to either SAP or MDI therapy. Quarterly A1C values were obtained from all subjects. CGM studies were carried out at baseline, 6 months, and 12 months to quantify glycemic excursions [calculated as area under the glucose concentration-time curve (AUC)] and variability. In the SAP group, sensor compliance was recorded. Results: Baseline A1C values were similar in subjects randomized to the SAP (8.26 ± 0.55%) and MDI groups (8.30 ± 0.53%). All subsequent A1C values showed significant (p < 0.05) treatment group differences favoring SAP therapy. Compared with the MDI group, subjects in the SAP group were more likely to meet age-specific A1C targets and had lower AUC values for hyperglycemia with no increased risk of hypoglycemia. Glucose variability improved in the SAP group compared to the MDI group. Children wore CGM sensors more often and were more likely to reach age-specific A1C targets than adolescents. Conclusions: SAP therapy allows both children and adolescents with marginally or inadequately controlled type 1 diabetes to reduce A1C values, hyperglycemic excursions, and glycemic variability in a rapid, sustainable, and safe manner. [ABSTRACT FROM AUTHOR]

Cemeroglu AP, Stone R, Kleis L, Racine MS, Postellon DC, Wood MA. Use of a real-time continuous glucose monitoring system in children and young adults on insulin pump therapy: patients' and caregivers' perception of benefit. Background: Real-time continuous glucose monitoring systems (RT-CGMS) are a recently introduced technology for type 1 diabetes and experience in children is limited. Objective: To assess patient and caregiver's perception of benefits and disadvantages of RT-CGMS in children or young adults with type 1 diabetes mellitus (DM) on insulin pump therapy. Subjects and Methods: Forty-three subjects (3–25 yr) on insulin pump therapy were included in the study. Thirty-four used RT-CGMS for a short-term trial (4 wk, ST group) and nine as a long-term tool (2–18 months, LT group). Forty subjects or their caregivers completed a questionnaire. Results: On the basis of the questionnaire responses, hypoglycemia prevention was the most common perceived benefit (88%), followed by elimination of hypoglycemia-related anxiety (83%), ease of pattern management (85%), improvement of diabetes control (80%), improvement of quality of life (78%), and ease of diabetes care (78%). Negative effects included irritation/annoyance from the sensor alarm (48%) and insertion site bruising, pain, or irritation (43%). A small percentage of patients who were interested in purchasing the device (12%) decided against using it LT after a 4-wk trial on RT-CGMS. Conclusions: The most common perceived benefits of RT-CGMS are prevention of hypoglycemia and decrease in hypoglycemia-related anxiety. Negative effects are uncommon and seem to be unlikely to affect the decision to use RT-CGMS for a LT. A ST trial seems to be a valuable tool for the patient/caregiver in determining whether to purchase the device and in setting realistic expectations of its potential benefits. [ABSTRACT FROM AUTHOR]

An algorithm designed to automatically control insulin delivery was tested in rats with Type 1 diabetes. This nonlinear algorithm included a fading memory component of proportional and derivative errors in order to simulate normal insulin secretion. Error-weighting functions for the proportional and derivative terms were used with a performance index designed for error adaptation. In the first version of the algorithm, the proportional gain was adaptively varied. In the second version, a low rate of basal insulin delivery was adaptively varied. Six 6-h studies with each version were conducted using frequent blood sampling and intravenous insulin delivery. In Version 2 studies, blood glucose levels during the last two hours were well-controlled and significantly lower than in Version 1 (118 ± 2.0 vs. 130 ± 2.9 mg/dL). Neither version produced hypoglycemia. Future research using this algorithm needs to focus on automated glucose sensing in combination with insulin delivery. [ABSTRACT FROM AUTHOR]

A closed loop system of diabetes control would minimize hyperglycemia and hypoglycemia. We therefore implanted and tested a subcutaneous amperometric glucose sensor array in alloxan-diabetic rats. Each array employed four sensing units, the outputs of which were processed in real time to yield a unified signal. We utilized a gain-scheduled insulin control algorithm which rapidly reduced insulin delivery as glucose concentration declined. Such a system was generally effective in controlling glycemia and the degree of lag between blood glucose and the sensor signal was usually 3–8 min. After prolonged implantation, this lag was sometimes longer, which led to impairment of sensor accuracy. Using a prospective two-point calibration method, sensor accuracy and closed loop control were good. A revised algorithm yielded better glycemic control than the initial algorithm did. Future research needs to further improve calibration methods and reduce foreign body fibrosis in order to avoid a time-related increase in lag duration. [ABSTRACT FROM AUTHOR]

Background: Type 1 diabetes mellitus (T1DM) afflicts approximately 154,000 people under the age of 20 in the United States. Most people with T1DM are diagnosed at a young age, and parents have to take on the responsibility of T1DM management. Eventually, the child must begin to transition to self-management. Adolescents often struggle to take on responsibility for all the necessary tasks to successfully self-manage their T1DM. In fact, approximately three-quarters of adolescents are not achieving American Diabetes Association-recommended glycated hemoglobin (HbA1c) targets. This lack of adherence can lead to negative health outcomes. Objective: The goals of this interdisciplinary proposal are as follows: (1) to develop a unique and theory-driven technology using a mobile phone app to promote self-management behaviors for adolescents aged 10-15 years with T1DM and their parents and (2) to explore the feasibility and impact of the self-management mobile app. Methods: This study has two phases: app development and pilot testing. In the app development phase, the app will be conceptualized and a prototype will be tested. In Phase 2, the mobile app will undergo pilot testing to determine its feasibility and impact on diabetes self-management. Results: The pilot test was launched in September 2017. Data collection for the final pilot test is underway, and results are forthcoming. Conclusions: Adolescents with T1DM and their parents can have a difficult time managing the transition of diabetes care. It is hoped that this app can help. The focus groups and prototype testing have indicated promising outcomes of app use. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ technology in children with type 1 diabetes (T1D).Methods: Participants (N = 105, ages 7-13 years, mean age 10.8 ± 1.8 years) were enrolled at nine centers (eight in the United States and one in Israel) and completed a 2-week baseline run-in phase in Manual Mode followed by a 3-month study phase with Auto Mode enabled. Sensor glucose (SG), glycated hemoglobin (HbA1c), percentage of SG values across glucose ranges, and SG variability, during the run-in and study phases were compared. Participants underwent frequent sample testing with i-STAT® venous reference measurement during a hotel period (6 days/5 nights) to evaluate the system's continuous glucose monitoring performance.Results: Auto Mode was used a median of 81% of the time. From baseline to end of study, overall SG dropped by 6.9 ± 17.2 mg/dL (P < 0.001), HbA1c decreased from 7.9% ± 0.8% to 7.5% ± 0.6% (P < 0.001), percentage of time in target glucose range (70-180 mg/dL) increased from 56.2% ± 11.4% to 65.0% ± 7.7% (P < 0.001), and the SG coefficient of variation decreased from 39.6% ± 5.4% to 38.5% ± 3.8% (P = 0.009). The percentage of SG values within target glucose range was 68.2% ± 9.1% and that of i-STAT reference values was 65.6% ± 17.7%. The percentage of values within 20%/20 of the i-STAT reference was 85.2%. There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the study phase.Conclusion: In-home use of MiniMed 670G system Auto Mode for 3 months by children with T1D, similar to MiniMed 670G system use by adolescents and adults with T1D, was safe and associated with reduced HbA1c levels and increased time in target glucose range, compared with baseline. [ABSTRACT FROM AUTHOR]

• The communication between parents and teens with T1DM is unique. • Providers must be aware how to best communicate with teens with T1DM. • Teens want their parents to be engaged in the process, but not in an aggravating way. • Teens report feelings of denial, shame, anger and embarrassment about having T1DM. • Teens and parents report that attending diabetes camps, having an insulin pump and a 504 plan helped improve adherence. The transition from parent management to teen self-management of type 1 diabetes (T1D) is a stressful, but important, time with substantial long-term health consequences. The purpose of this study was to describe and explore teens' and their parents' perspectives on the transition through the transactional model of stress and coping (TMSC). This evidence will provide us an understanding of key variables of the TMSC to target in an intervention. This qualitative study included 12 teens and 9 parents in Michigan. Subjects participated in semi-structured interviews designed to examine the transition process, using TMSC as a guide. Several themes emerged through the analysis of the interview data. The results of the themes are presented by primary and secondary appraisals. The primary appraisal theme was coded as fear. The secondary appraisal was focused on family communication. Finally, the coping strategies included provider communication, social support and tangible support. Improving parent involvement and providing more social support and educational opportunities to both parents and teens can be possible avenues for new coping interventions. [ABSTRACT FROM AUTHOR]