PREP-T1 (Preteen Re-Education With Parents-Type 1 Diabetes) Feasibility Intervention Results.

There has been a 2% to 3% increase in Type 1 diabetes (T1D) in children below 11 years old. Preteens (9-12 years old) with T1D are often overlooked regarding future diabetes self-management (DSM) expectations because parents are still in the "driver's seat." The study purpose was to explore feasibility/ability to recruit and conduct a two-arm trial on reeducation, collaboration, and social support. One component of DSM was reviewed (hypoglycemia) with preteens (n = 22) and parents (n = 22). The experimental preteens discussed hypoglycemia management with a teen mentor and nurse educator using a human patient simulator for practice, and working collaboratively with parents. Concurrently, mothers met with a parent mentor and psychologist to discuss growth and development, and collaborative shared management. Comparison dyads discussed hypoglycemia management with a nurse. Preteens slightly improved in diabetes knowledge; the experimental arm had higher problem-solving scores. Parents in the experimental arm had higher self-efficacy scores. Findings will inform future research.

Virtual Coaching to Enhance Diabetes Care.

Rates of diabetes are increasing worldwide and there is not a sufficient clinical workforce to care for these patients. Diabetes-related apps are a feasible way to provide diabetes education to large numbers of people with diabetes but attrition rates are high. Apps enhanced by virtual coaching may be a way to circumnavigate these problems. Virtual coaches are able to address common treatment barriers and other health disparities by providing data-driven individualized support in real time, at any time of day, and from anywhere. Enhanced glycemic benefits have been seen in those who use an app plus virtual coaching versus those who use an app alone, along with clinically meaningful behavior change, psychosocial effects, prolonged engagement, and high levels of satisfaction with the system. More research needs to be done to determine the longitudinal and widespread effects of virtual coaching in different populations.

Challenges to Diabetes Self-Management in Emerging Adults With Type 1 Diabetes.

PURPOSE: The purpose of this qualitative descriptive study undergirded by Meleis's Transition Framework was to explore developmental, situational, and organizational challenges experienced by a diverse group of emerging adults (18-29 years old) with type 1 diabetes (T1DM). Their perspectives on creating a developmentally informed diabetes self-management (DSM) program that supports transitional care were also explored. METHODS: A purposive sample of emerging adults with T1DM was recruited from the pediatric and adult diabetes clinics of an urban academic medical center. Those who consented participated in either a single focus group or a single interview. Self-reported demographic and clinical information was also collected. RESULTS: The sample was comprised of 21 emerging adults, with an average age of 23.6 ± 2.6 years, diabetes duration of 14.7 ± 5.0 years, and 71% female. Four main themes emerged: (1) finding a balance between diabetes and life, (2) the desire to be in control of their diabetes, (3) the hidden burden of diabetes, and (4) the desire to have a connection with their diabetes provider. Use of insulin pumps and continuous glucose monitors and attendance at diabetes camp decreased some of the DSM challenges. Different groups of individuals had different perspectives on living with diabetes and different approaches to DSM. CONCLUSIONS: The emerging adults in this study had a strong desire to be in good glycemic control. However, all participants described having a hard time balancing DSM with other competing life priorities. They also desired personalized patient-provider interactions with their diabetes care provider in clinical follow-up services. Even though the study sample was small, important themes emerged that warrant further exploration.

Insulin receptor autoimmunity and insulin resistance.

The frequency of insulin receptor autoantibodies (IR-ab) was determined among adolescents and young adults with documented insulin resistance syndrome (IRS) with and without concomitant autoimmunity. The study population was comprised of 61 patients with obesity, acanthosis nigricans and insulin resistance (simple IRS); 12 with IRS and other autoimmune problems (lupus erythematosus, rheumatoid arthritis, dermatomyositis) (type B insulin resistance); six with autoimmune polyglandular syndrome type 2; and 40 healthy controls. Using our newly developed radiobinding assay system, we found no control positive while 25% of the patients with type B IRS (3/12) were positive, as expected. However, we found that 9.8% of the patients with simple IRS (6/61) were also reproducibly positive. All the latter patients with positive IR-ab were female with ovarian hyperandrogenism. The phenotype of those affected was otherwise unremarkably different from those without IR-ab. Our findings suggest that autoimmunity to insulin receptors may be causal in IRS especially for females with ovarian hyperandrogenism, and that IR-ab may be found in IRS besides those previously defined by the type B phenotype. Determining the level of IR-ab in childhood onset IRS may provide mechanistic insights into the genesis of insulin resistance and lead to novel treatment approaches.

Resting energy expenditure in insulin resistance falls with decompensation of insulin secretion in obese children.

BACKGROUND: Low resting energy expenditure (REE) and respiratory quotient (RQ) have been shown in adults to predispose to obesity and diabetes mellitus. AIM: To correlate REE and RQ in 73 obese children and young adults (body mass index [BMI] 37 +/- 10 kg/m2) with measures of insulin secretion and resistance (IR) indices, percent carbohydrate and fat oxidation, and prolactin and leptin levels. DESIGN: During a 3-day admission, REE and RQ were determined by indirect calorimetry. Blood chemistries and oral glucose tolerance test (OGTT) were obtained, and intravenous glucose tolerance test (IVGTT) modified by tolbutamide was conducted after an overnight fast, permitting calculation of acute insulin response (AIR), insulin resistance (SiIVGTT), and disposition index (DI). RESULTS: Patients fell into two groups according to their SiIVGTT: those with normal insulin sensitivity (NIS) and those with insulin resistance (IR). IR patients were subdivided on the basis of DI (cut-off value 0.13 min(-1)) into compensated (CIR) or decompensated (DIR) groups. CIR patients had higher RQ, REE corrected by BMI, AIR, and carbohydrate oxidation and lower fat oxidation than NIS and DIR patients. REE correlated positively with BMI, leptin, and AIR, and negatively with SiIVGTT. CONCLUSIONS: Findings in the CIR and DIR groups support the correlation of REE with metabolic changes consistent with an increased risk of diabetes mellitus.

Provider Perspectives on Partnering With Parents of Hospitalized Children to Improve Safety.

BACKGROUND AND OBJECTIVES: There is increasing emphasis on the importance of patient and family engagement for improving patient safety. Our purpose in this study was to understand health care team perspectives on parent-provider safety partnerships for hospitalized US children to complement a parallel study of parent perspectives. METHODS: Our research team, including a family advisor, conducted semistructured interviews and focus groups of a purposive sample of 20 inpatient pediatric providers (nurses, patient care technicians, physicians) in an acute-care pediatric unit at a US urban tertiary hospital. We used a constant comparison technique and qualitative thematic content analysis. RESULTS: Themes emerged from providers on facilitators, barriers, and role negotiation and/or balancing interpersonal interactions in parent-provider safety partnership. Facilitators included the following: (1) mutual respect of roles, (2) parent advocacy and rule-following, and (3) provider quality care, empathetic adaptability, and transparent communication of expectations. Barriers included the following: (1) lack of respect, (2) differences in parent versus provider risk perception and parent lack of availability, and (3) provider medical errors and inconsistent communication, lack of engagement skills and time, and fear of overwhelming information. Providers described themes related to balancing parent advocacy with clinician's expertise, a provider's personal response to challenges to the professional role, and parents balancing relationship building with escalating safety concerns. CONCLUSIONS: To keep children safe in the hospital, providers balance perceived challenges to their personal and professional roles continuously in interpersonal interactions, paralleling parent concerns about role ambiguity and trust. Understanding these shared barriers to and facilitators of parent-provider safety partnerships can inform system design, parent education, and professional training.

Prevalence and clinical features of type 1.5 diabetes mellitus in children.

AIM: To classify children with diabetes mellitus as type 1, 1.5 or 2, based on strict criteria, and then compare their features and treatment. METHODS: In this retrospective study, all children with diabetes mellitus in our clinic with antibody status available (n = 120) were reclassified as type 1, 1.5 or type 2 based on status of antibodies to the pancreas and presence of obesity and/or acanthosis nigricans, and their features compared. RESULTS: Sixty-four percent of type 2 patients were reclassified as type 1.5. Type 1.5 patients had significantly lower BMI SDS, blood pressure and acanthosis nigricans than type 2 patients. They had a higher insulin requirement (0.82 +/- 0.44 U/kg/day) than type 1 (0.72 +/- 0.35 U/kg/day) or type 2 (0.28 +/- 0.3 U/kg/day) patients. Total cholesterol, HDL-cholesterol, ALT and AST significantly worsened from type 1 to 1.5 to type 2 patients. CONCLUSIONS: Type 1.5 diabetes mellitus should be considered among obese adolescents presenting as type 2, as their clinical course is more aggressive and insulin requirement higher.

Characterization of insulin resistance syndrome in children and young adults. When to screen for prediabetes?

CONTEXT: Insulin resistance syndrome (IRS) is associated with the development of type 2 diabetes mellitus (DM2). However, it is unclear which individuals with insulin resistance will develop DM2. AIM: To study the prevalence of IRS in childhood and to identify the group with the highest risk of further progression to DM2. METHODS: In a cross-sectional study, 86 obese individuals underwent an intravenous glucose tolerance test (IVGTT). Insulin resistance index (Si(IVGTT)), acute insulin response (AIR) and disposition index (DI) were calculated from IVGTT. RESULTS: For analysis the participants were divided into insulin-sensitive (IS) (n = 25, 13.3 +/- 5.9 yr) and insulin-resistant (IR) groups on the basis of having an Si(IVGTT) greater or lesser than 4.5 x 10(-4) mU/ml/min, respectively. The IR group was then subdivided according to DI, with the standard cut-off value of 0.13 min(-1), into compensated IR (CIR) (n = 37, 13.0 +/- 3.5 yr) and decompensated IR (DIR) (n = 24, 21.9 +/- 12.6 yr) groups. The frequency of IRS was 43% in children, 78% in adolescents and 83.6% in adults. Decompensated insulin response first appeared during adolescence. The frequency of decompensation increased from 22% in adolescence to 67% in adulthood. The DIR group had increased triglycerides (TG) and urinary free cortisol levels. CONCLUSIONS: The frequency and severity of IR increases with age. Decompensation first presents in adolescence with low AIR and elevated TG. Decompensated adolescents are the group at highest risk for further progression to DM2.

CDE Perspectives of Providing New-Onset Type 1 Diabetes Education Using Formal Vignettes and Simulation.

Purpose The purpose of this article is to describe the 4 Parent Education Through Simulation-Diabetes (PETS-D) nurse certified diabetes educators' (CDEs) perspectives of teaching parents of children with newly diagnosed type 1 diabetes mellitus (T1DM) early diabetes management skills using formal vignettes and a human patient simulator/human patient simulation (HPS) to augment/enhance the teaching-learning process. Methods A qualitative descriptive approach was used. Four CDEs were interviewed by phone about their teaching experiences. Meticulous notes were taken. Data were analyzed using qualitative content analysis. Results The vignettes (and use of HPS) provided structure, especially for parents who were struggling to learn. Certified diabetes educators described a short learning curve to master the use of the HPS manikin. Human patient simulation-enhanced education was described as helpful for teaching multiple caregivers about diabetes. Certified diabetes educators also described factors that affect parent learning, mechanical issues with the HPS, and additional space requirements for HPS-enhanced education. Conclusion Vignettes and HPS-enhanced education can successfully be used to educate parents of children with new-onset T1DM and were preferred by the CDEs when compared with previous teaching strategies. The results of this study support the use of both vignette-based and HPS-enhanced education when a child is newly diagnosed with T1DM. Further studies need to be done to see if these effects persist with different populations, during different stages of the disease, and for individuals with other chronic illnesses.

Insulin pump therapy from the time of diagnosis of type 1 diabetes.

BACKGROUND: This study was designed to test the feasibility and efficacy of continuous subcutaneous insulin infusion (CSII) being instituted within 1 month of diagnosis of type 1 diabetes mellitus (T1DM). METHODS: Twenty-eight consecutive patients with newly diagnosed T1DM with a mean age of 12.1 +/- 6.2 years were placed on CSII, as early as within 1 day of their diagnosis. All accepted CSII when offered it, and none elected to discontinue CSII after follow-up periods of up to 3 years. RESULTS: Hemoglobin A1c levels declined from an initial mean of 10.5 +/- 2.4% to between 6.5% and 7.4% over the next 18 months, at a mean insulin requirement of 0.33 units/kg/day at 3 months, which gradually rose to 0.58 units/kg/day by 18 months. Endogenous insulin secretion, measured by C-peptide values, remained stable during the first 12 months after diagnosis. There was no significant weight gain for the duration of the study (20.7 kg/m(2) vs. a peak of 22.1 kg/m(2) at 12 months, P = 0.54). CONCLUSIONS: The study provided a positive experience with CSII as the initial insulin replacement therapy in newly diagnosed patients with T1DM with excellent clinical outcomes and apparent prolongations of the honeymoon period. It remains to be proven by random patient assignment whether endogenous insulin secretion is better preserved with CSII as an initial ongoing treatment modality and whether long-term complications are reduced by this approach.

Adjuvant Liraglutide and Insulin Versus Insulin Monotherapy in the Closed-Loop System in Type 1 Diabetes: A Randomized Open-Labeled Crossover Design Trial.

BACKGROUND: The closed-loop (CL) system delivers insulin in a glucose-responsive manner and optimal postprandial glycemic control is difficult to achieve with the algorithm and insulin available. We hypothesized that adjunctive therapy with liraglutide, a once-daily glucagon-like peptide-1 agonist, would be more effective in normalizing postprandial hyperglycemia versus insulin monotherapy in the CL system, in patients with type 1 diabetes. METHODS: This was a randomized, controlled, open-label, crossover design trial comparing insulin monotherapy versus adjuvant subcutaneous liraglutide 1.2 mg and insulin, using the CL system in 15 patients. Blood glucose (BG), insulin, and glucagon concentrations were analyzed. RESULTS: The liraglutide arm was associated with overall decreased mean BG levels (P = .0002). The average BG levels from 8:00 pm (day 1) to 9:00 pm (day 2) were lower in the liraglutide arm (144.6 ± 36.31 vs 159.7 ± 50.88 mg/dl respectively; P = .0002). Two-hour postbreakfast and lunch BG profiles were better in the liraglutide arm (P < .05) and the insulin and glucagon assay values were lower (P < .0001). Postprandially, the area under the curve (AUC) for 2-hour postbreakfast and lunch BG levels were significant (P = .01, P = .03) and the AUC for glucagon, postbreakfast (P < .0001) and lunch (P < .05), was also significant. The incidence of hypoglycemia did not differ between arms (P = .83, Fisher's exact test). Overall, adjunct liraglutide therapy plus CL was well tolerated even with expected side effects. CONCLUSION: This is a proof-of-concept study showing liraglutide can be a potential adjunctive therapy in addition to CL with insulin to reduce postprandial hyperglycemia in type 1 diabetes.

PETS-D (parents education through simulation-diabetes): Parents' qualitative results.

OBJECTIVE: Parents who have a child newly diagnosed with type 1 diabetes (T1D) must quickly learn daily diabetes self-management. An RCT was conducted using human patient simulation (HPS) to enhance parents learning diabetes self-management with children with new-onset T1D. The purpose of this study was to describe parents' perspectives of using HPS to augment diabetes education. METHODS: A qualitative descriptive design was used with open-ended in-depth interviews of parents (n=49) post-intervention. Qualitative directed content analysis was used. RESULTS: The majority of parents were positive about learning with HPS. Although a few parents said the HPS was "hokey" or "creepy," most reported the visual and hands-on learning was realistic and very beneficial. Seeing a seizure increased their fear although they would have panicked if they had not had that learning experience, and it helped build their diabetes self-management confidence. Recommendations included teaching others with the HPS (grandparents, siblings, babysitters, and school nurses). CONCLUSION: HPS-enhanced education is an acceptable and viable option that was generally well-received by parents of children with new-onset T1D. PRACTICE IMPLICATIONS: The technique should be studied with parents of children with other chronic illnesses to see if the benefits found in this study are applicable to other settings.

Preteen-parent experiences with PREP-T1 feasibility intervention.

PURPOSE: The purpose of this article is to report the focus group perspectives of preteens' and parents' experiences with a feasibility intervention entitled PREP-T1 (Preteen Re-Education with Parents-Type 1 Diabetes), an interactive education and peer mentoring intervention. METHODS: The parent and preteen focus groups were conducted by the principal investigator, coinvestigator, and note takers at 2 sites. The preteen-parent groups were conducted concurrently with a total of 11 preteens and 11 parents. Note-based qualitative content analysis was used, resulting in preteen-parent perspectives on reeducation and strategies for families to work more effectively in managing type 1 diabetes (T1DM). RESULTS: The findings suggest that the preteens enjoyed learning about their diabetes management from a teen educator mentor in conjunction with a human patient simulator. They reported this type of peer support would benefit other preteens with T1DM. Parents were overwhelmingly positive about their interactions with the parent educator mentor in conjunction with the psychologist and about focusing on how to better collaborate with their preteens on diabetes management decision making. Further recommendations about the timing and intervention dose were also discussed. CONCLUSIONS: Moderated peer mentoring with technology has potential as a means for teaching preteens and their parents shared diabetes management. These data will be used to inform the PREP-T1 fully powered intervention study.

PETS-D: Impact on Diabetes Management Outcomes.

OBJECTIVE: To evaluate the efficacy of Parent Education Through Simulation-Diabetes (PETS-D; clinical trial registration NCT01517269) for parents of children <13 years old newly diagnosed with type 1 diabetes with 3 parent education vignette sessions using human patient simulation (HPS) as compared with formal parent-nurse education sessions (vignette only) regarding diabetes knowledge, problem-solving skills, hypoglycemia fear, anxiety, and self-efficacy. DESIGN AND METHODS: Subjects were randomized to the HPS parent diabetes education or the vignette-only arm. Using linear mixed modeling, we compared HPS and vignette-only groups at 2, 6, and 14 weeks. Effect modification of treatment by dichotomized child's age (<6 and ≥ 6 years old) and parent education (≤ high school and >high school) was also tested. All analyses were intent to treat and adjusted for baseline outcome level and clustering within site. RESULTS: We recruited 191 parents (116 children). Mean baseline A1C was 12%. Overall treatment-related differences were modest. There was a statistically significant effect modification of HPS by child's age, with a larger HPS benefit among parents of younger children for several outcomes: A1C (8.16% vs 9.48% in control; P = .006), lower state anxiety (P = .0094), and higher fear of hypoglycemia (P = .03) for parents of children <6 years old in the HPS group. CONCLUSIONS: Modest treatment-related differences may reflect ceiling/floor effects in many of the outcomes; we also compared HPS with another intervention rather than to usual education. Parents of younger children receiving the intervention may feel more comfortable with lower A1C levels because of management awareness gleaned from the HPS experience. Future research will include a retrospective case-control study of very young children.

Role of glucagon-like peptide-1 analogue versus amylin as an adjuvant therapy in type 1 diabetes in a closed loop setting with ePID algorithm.

Postprandial hyperglycemia due to paradoxical hyperglucagonemia is a major challenge of diabetes treatment despite the use of the artificial pancreas. We postulated that adjunctive therapy with pramlintide or exenatide would attenuate hyperglycemia in the postprandial phase through glucagon suppression, thereby optimizing the functioning of the closed-loop (CL) system. Subjects with type 1 diabetes (T1DM) on insulin pump therapy were recruited to participate in a 27-hour hospitalized admission on 3 occasions (2-4 weeks apart) and placed on the insulin delivery via CL system in random order to receive (1) insulin alone (control), (2) exenatide 2.5 µg + insulin, (3) pramlintide 30 µg + insulin. Medications were given prior to lunch and dinner, which was a standardized meal of 60 grams of carbohydrates. Insulin delivery was as per the ePID algorithm via the Medtronic CL system and continuous subcutaneous glucose monitoring via Medtronic Sof-sensors. Ten subjects age 23 ± 1 years with a HbA1c of 7.29 ± 0.3% (56 ± 1 mmol/mol) and duration of T1DM 10.6 ± 2.0 years participated in the 3-part study. Exenatide was found to be significantly better in attenuating postprandial hyperglycemia as compared to insulin monotherapy (P < .03) and pramlintide (P > .05). Glucagon suppression was statistically significant with exenatide (P < .03) as compared to pramlintide. Insulin requirements were lower with adjunctive therapy, but statistically insignificant. Insulin monotherapy results in postprandial hyperglycemia in T1DM in the CL setting and adjunctive therapy with exenatide reduces postprandial hyperglycemia effectively and should be considered as adjunctive therapy in T1DM.

New technologies for diabetes: a review of the present and the future.

: This review summarizes the technologies in use and in the pipeline for the management of diabetes. The review focuses on glucose meters, continuous glucose monitoring devices, insulin pumps, and getting clinicians connected to technologies. All information presented can be found in the public domain, and was obtained from journal articles, websites, product review tables in patient publications, and professional conferences. The technology concerns, ongoing development and future trends in this area are also discussed.

Real-life utilization of real-time continuous glucose monitoring: the complete picture.

BACKGROUND: Very few studies to date have analyzed the reasons why some people do not use real-time continuous glucose monitoring (RT-CGM) continuously, especially given its positive glycemic outcomes, or choose not to wear it at all, even after learning about its benefits. METHODS: A questionnaire was designed to assess real-life use of and issues surrounding RT-CGM. Hemoglobin A1c (HbA1c) and duration of sensor use were also obtained from the patients' charts. RESULTS: Fifty-eight subjects with type 1 diabetes (T1DM), average age 15.0 ± 4.8 years, T1DM duration 5.7 ± 3.8 years, HbA1c 8.8 ± 2.1%, 50% with RT-CGM, were included in the analysis. Hemoglobin A1c was lower with increased RT-CGM use. Real-time continuous glucose monitoring was ordered to improve control. Users liked the continuous data. The most disliked part was pain and discomfort. Occasional users described RT-CGM as annoying, a hassle, and interfering with their lives. Reasons for discontinuing RT-CGM included problematic equipment and inaccuracy (64%), intrusion in life (36%), and insurance issues (29%). Twenty-one percent of nonusers reported RT-CGM to be inconvenient or a hassle or just did not want it. Fifty-two percent of subjects continue to use RT-CGM despite reported problems. CONCLUSION: Real-time continuous glucose monitoring is a beneficial tool for improving glycemic control, and many use it despite reported problems and hassles with current devices. However, this technology has not been wholeheartedly embraced by many individuals with T1DM, especially in youngsters, because of issues mentioned here. Based on the findings of this study, it is hoped that improvements will be made to RT-CGM technology so that more people with diabetes will embrace this beneficial tool.

Basal insulin requirements on continuous subcutaneous insulin infusion during the first 12 months after diagnosis of type 1 diabetes mellitus.

INTRODUCTION: While the endogenous first-phase insulin response has disappeared by the time of diagnosis of type 1 diabetes mellitus (T1DM), anecdotal evidence suggests that these patients can continue to have a second-phase insulin response during the first 12 months after diagnosis. We hypothesized that patients who are started on continuous subcutaneous insulin infusion (CSII) at the time of diagnosis of T1DM would have a lower basal insulin requirement than the 40-60% usually expected. METHODS: We analyzed 38 patients with T1DM, age 9.9 +/- 6.4 years, 71% male, who were started on CSII within the first month of diagnosis. RESULTS: Average basal insulin requirements were 47-49% of total daily dose during the first 12 months after diagnosis and decreased from 0.30 U/kg/day at diagnosis to 0.20 U/kg/day by 12 months. Baseline percentage of basal insulin was significantly correlated with hemoglobin A1c at baseline and at six months. The percentage of basal insulin requirement at 12 months after diagnosis was significantly correlated with baseline body mass index (BMI) and current BMI. No other correlations between percentage of basal insulin requirements and any other factors were seen. CONCLUSION: Our data suggest that, even though some endogenous insulin production remains during the first year after diagnosis of T1DM, the distribution of basal versus total daily insulin requirements remains the same as in the general population of people with diabetes. There may be benefits to starting patients on a higher basal rate at time of diagnosis for overall glycemic control during the first six months. Further research is needed to optimize starting insulin doses to maximize their potential in preserving beta-cell function.