DKA Events Research Articles

842-P: Damage Control (Group) for Youth with T1D: Capturing the True Value of NICH

Objective: Novel Interventions in Children’s Healthcare (NICH) is an ecologically valid intervention for youth with T1D who experience avoidable acute complications. While NICH has been associated with reductions in DKA events, the true impact of NICH is unclear without a control group. This study compares NICH youth utilization over time to youth referred to but denied NICH by insurance (i.e., unserved). Methods: Medical providers referred youth with T1D who experienced avoidable utilization to NICH (n=110). Unserved youth (n=50) were more likely than NICH youth (n=60) to have commercial insurance and less accessible medical records. There were no demographic differences between the groups (M age=14.0 years; 58% were female; 79% were non-Hispanic white). Medical record review included 1 year prior to and 2 years following NICH. Results: NICH youth had more documented hospital admissions and ED visits in the year prior to services (p<.05) than unserved youth. Compared to unserved youth, NICH youth experienced a greater reduction in days admitted during the 1st year and in DKA events in the 2nd year post-initiation (p<.05). Conclusions: This study was the first to compare NICH to a control group. NICH youth demonstrated greater reductions in acute complications following treatment; however, findings indicate that these groups were different in important ways, likely under capturing control group utilization following referral. Disclosure D.V. Wagner: None. C. Jenisch: None. N.C. Koskela-Staples: None. I. Guttmann-Bauman: None. C.E. Larsen: None. L. Teplitsky: None. M.A. Harris: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

SAT-LB025 Analysis of Benefit/Risk in the Subgroup of Patients with BMI of >=27 Kg/m2 in the Dapagliflozin DEPICT-1 and -2 Trials in Type 1 Diabetes

Sodium glucose co-transporter-2 inhibitor (SGLT-2i) adjunct therapies have been studied in phase 3 programs for use in people with type 1 diabetes (T1D) and are currently under regulatory review for approval in adults in North America, Europe, and Japan. The DEPICT-1 and -2 programs assessed dapagliflozin (DAPA) 5 and 10 mg in adults with T1D. Treatment with DAPA in people with T1D resulted in important benefits with a manageable risk profile, though there was a higher incidence of events adjudicated as definite DKA in those receiving DAPA. During the 52-week study period, in the total population, the proportion of patients with events adjudicated as definite DKA events was 4.0% and 1.1% in the DAPA 5 mg and PBO groups, with incidence rates of 4.6 and 1.3 per 100 patient years, respectively. However, in the subgroup of patients with BMI ≥27 kg/m², the proportion of patients with events adjudicated as definite DKA was reduced to 1.8% and 1.0%, with incidence rates per 100 patient-years of 1.9 and 1.2 in the DAPA 5 mg and PBO groups, respectively. Efficacy endpoint results for the subgroup with BMI ≥27 kg/m2 were similar to the overall population. After 24 weeks of treatment, HbA1c decreased from a baseline mean of 8.43 to 7.98% in the 5 mg group vs. 8.40 to 8.38% for PBO, with a PBO-corrected difference of –0.43% (95% CI –0.55, –0.31). Mean insulin dose decreased from 72.07 to 64.65 IU in the 5 mg group vs. 70.90 to 70.37 IU for PBO, with a PBO-corrected difference of –10.24 IU (95% CI –13.52, –6.84). Mean body weight decreased from 91.22 to 88.54 kg in the 5 mg group vs. 92.89 to 93.15 kg for PBO, with a PBO-corrected difference of –2.89 kg (95% CI –3.43, –2.36). As assessed by continuous glucose monitoring, mean interstitial glucose decreased from 192.52 to 176.19 mg/dL in the 5 mg group vs. 191.25 to 192.38 mg/dL for PBO, with a PBO-corrected difference of –16.81 mg/dL (95% CI –21.37, –12.25). Mean amplitude of glycemic excursions, a measure of glucose variability, decreased from 169.10 to 148.78 mg/dL in the 5 mg group vs. 164.94 to 163.71 mg/dL for PBO, with a PBO-corrected difference of –17.48 mg/dL (95% CI –22.28, –12.67). Mean time in the target glycemic range (glucose >70 and <180 mg/dL) increased from 44.17% to 53.65% in the 5 mg group vs. 44.67% to 44.44% for PBO, with a PBO-corrected difference of +9.69% (95% CI +7.61, +11.77) without increasing time in a hypoglycemic state (glucose <70 mg/dL). The proportion of patients achieving a reduction in HbA1c ≥0.5% without experiencing severe hypoglycemia was 47.2% in the 5 mg group vs. 21.3% for PBO, with 3.52 (95% CI 2.39, 5.21) greater odds of achieving this endpoint in those receiving 5 mg. In summary, while the benefit/risk profile of DAPA is favorable in the entire T1D study population, in this post-hoc analysis the benefit/risk appeared to be further enhanced in the subgroup of patients with BMI ≥27 kg/m² receiving DAPA 5 mg. Funded by AstraZeneca. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. s presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.

Youth with Avoidable DKA—Going from Bad to Worse without NICH

Objective: Novel Interventions in Children’s Healthcare (NICH) was developed for youth with T1D who experience avoidable DKAs. Previous findings suggest that NICH participation is associated with fewer PICU visits, hospital admissions, and DKA events, but interpretation is limited due to possibility of regression to the mean. This study examines whether youth experience fewer acute events during the wait period following referral to NICH. Methods: Retrospective chart reviews were conducted for youth with T1D (n=63) who participated in NICH services. Youth mean age was 14.8 years; 57% were female; and 86% were Caucasian. Mean days prior to referral, on wait list, and during NICH were 365, 129, and 353, respectively. Results were normalized across time points to reflect rate of likely event occurrence during 1 year period. Results: Youth were significantly more likely to experience a PICU stay (p=.03) while waiting for NICH compared to baseline and were significantly less likely to experience a DKA (p=.02) or PICU stay (p=.01) during NICH involvement compared to the wait period. Conclusions: Instead of spontaneously improving after baseline (i.e., regression to the mean), youth referred to NICH experience an increase in acute complications while waiting for services, then improvement during NICH involvement. Perhaps referring providers are identifying factors that suggest further deterioration of health without more intensive services. Disclosure R. Sachdej: None. N.C. Koskela: None. D.V. Wagner: None. S.A. Barry: None. C. Jenisch: None. M.A. Harris: Consultant; Self; Eli Lilly and Company.

Ketones to Success—Does NICH Involvement Influence DKA Discharge Presentation?

Objective: Youth struggling with diabetes management are at increased risk of DKA. Novel Interventions in Children’s Healthcare (NICH) is designed for youth with T1D who are experiencing or are at high risk of experiencing DKA. Previous findings from smaller samples indicate that youth in NICH are less likely to experience a DKA event and typically experience a shorter average hospital stay. However, counter to physician anecdotes, DKA-related lab values at admission for NICH patients do not differ from labs prior to program involvement. This study aims to determine whether patients in NICH are being discharged when less stable. Methods: Retrospective chart reviews were conducted on 52 youth enrolled and treated with NICH. Data included presence and number of DKA episodes in the year prior to and the year following NICH enrollment, as well as associated lab values at discharge—ketones, blood glucose level, bicarb, and pH. The mean youth age was 14.7 years (SD=3.5); 55.8% were female; and 92.3% were caucasian. Eighteen youth had lab values associated with DKA discharge available both prior to and during NICH. Results: Youth were less likely (p=.001) to experience DKA during NICH (35.3%) than prior to NICH (69.2%) and experienced fewer DKA events (t(51)=3.53; p=.001) during NICH (M=1.0; SD=1.8) than prior (M=1.8; SD=2.1). Regarding discharge presentation, only the presence of ketones indicated a significant difference (t(17)=2.11; p=0.5), with patients in NICH being discharged with trace to small ketones on average while in the program, as opposed to negative to trace ketones prior to program involvement. Conclusions: Youth in NICH experience fewer DKA events and are less likely to experience a DKA during program involvement. In addition, youth are discharged, on average, with a stronger presence of ketones during NICH than prior to program involvement. This may reflect increased medical provider confidence that ketones and associated youth health can be managed at home when NICH providers are involved. Disclosure D.V. Wagner: None. R. Chuong: None. N.C. Koskela: None. H. Luzod: None. E. Beeson: None. I. Guttmann-Bauman: None. M.A. Harris: Consultant; Self; Eli Lilly and Company.

Timing of Meal Insulin and Its Relation to Adherence to Therapy in Type 1 Diabetes.

The purpose of this study is to examine timing of meal insulin and further determine whether an association exists between timing of meal insulin and missed meal insulin doses. The cohort included 4768 T1D Exchange clinic registry participants <26 years with type 1 diabetes ≥1 year. Chi-square tests, t-tests, and regression were used to assess the relationship between participant characteristics and timing of meal insulin and missed meal doses, respectively. Timing of meal insulin and association with missed meal doses was analyzed using logistic regression. In all, 21% reported administering insulin several minutes before, 44% immediately before, 10% during, and 24% after meal. Participants who gave insulin prior to a meal had significantly lower HbA1c than those who gave insulin during or after meal (8.4% ± 1.5% vs 8.8% ± 1.6%, adjusted P < .001), but no significant association was observed regarding DKA events. Those who reported missing ≥1 insulin dose per week had higher HbA1c (9.8% ± 1.9% vs 8.3% ± 1.3%, adjusted P < .001) and were more likely to experience at least one DKA event (9% vs 5%, adjusted P = .001) compared with those who rarely missed a meal insulin dose. Participants who reported administering insulin during or after a meal were more likely to report missing ≥1 meal insulin dose per week compared with those who administered insulin before a meal (28% vs 14%, adjusted P < .001). Premeal insulin was associated with lower HbA1c and fewer missed meal insulin doses. Providers may use this information to discuss the benefits of premeal insulin on glycemic control and adherence to therapy.

Multiple educational programs improves glycemic control, quality of life with diminishing the impact of diabetes in poorly controlled type 1 diabetics

AimsThe aim of present study was to assess the outcomes of multiple educational programs on glycemic control, quality of life and impact of diabetes in poorly controlled Type 1 Diabetic patients. Participants and methodsA 12 months diabetes education programs were conducted every week for first one month then followed by every 3 months with follow up on improvement of HbA1c and QOL in T1D patients (n=54). Clinical characteristics were recorded at baseline visit. The QOL was evaluated by 15 set DQOL questionnaires in 40 consecutive patients at baseline, 3, 6 and 12 months after education programs. The HbA1c level (%) was evaluated at same time point. Decrease in DQOL score was reported as improvement in QOL. ResultsThe rate of patients response to educational programs was noted 74.07% (n=40) at end of the study (12 months). The prevalence of T1D was reported higher in men than in women. The overall DQOL score and HbA1c% level was significantly (P<0.05) decreased at 3, 6 and 12 months after educational programs. Patients exhibited greater satisfaction and diminished impact of diabetes after educational programs was observed after 3 months and it was continue up to end of study. The frequencies of self-monitoring of blood glucose were increased. Numbers of hypoglycemic and DKA events were decreased after educational programs when compared to baseline. ConclusionResults of study revealed that the appropriate education and counseling diminish impact of diabetes, improve QOL and help to achieve desired glycemic (HbA1c) level in poorly control T1D patients.

Infusión subcutánea continua de insulina en menores de 6 años: evolución a largo plazo

ObjectiveThe aims of the study are to evaluate the efficacy and safety of continuous subcutaneous insulin infusion (CSII) treatment in pre-school children with type I diabetes, and to assess whether the criteria of good metabolic control are achieved. MethodA review was performed on the medical charts of patient's<6 years of age who started CSII treatment between 2003 and 2014. The cohort consisted of 27 patients (mean age 4 (2.9-4.7) years, 56% males). An analysis was made including the age at onset, type I diabetes duration, HbA1c (HPLC, Menarini, normal value 5.1±0.31%), insulin dose (u/kg/day), number of capillary blood glucose measurements, number of baseline processes per day, % baseline/total insulin (B/TI), insulin ratios (I/HC) at different meals, severe hypoglycaemia (HS episodes/100 patients years), DKA events, percentages of normal blood glucose (70-180mg/dl), hyperglycaemia (>180mg/dl), and hypoglycaemia (<70mg/dl), mean blood glucose, standard deviation and coefficient of variation (SD/mean glucose ×100). Statistical analysis was performed using SPSS. ResultsHbA1c decreased from 6.9% (6.7-7.5) to 6.8% (6.4-7.1) after one year of CSII. Afterwards, it remained under 6.8% during the follow-up (median 5 years [3-6]). Prior to CSII, 74% of children had HbA1c levels < 7.5%. It increased to 96% after one year of CSII. Median blood glucose measurements /day was 10 (9-11). Total insulin dose did not change significantly. During the follow-up, there was one episode of DKA and one episode of HS. I/HC at breakfast were higher than at other meals (0.92 vs. 0.55, 0.6 and 0.5, respectively). ConclusionsCSII is effective and safe in pre-school children. It allows good metabolic control (based on Society for Paediatric and Adolescent Diabetes / American Diabetes Association criteria) to be achieved and maintained for long periods of time without an increase in adverse events.

Insulin dose adjustment when changing from multiple daily injections to continuous subcutaneous insulin infusion in the pediatric age group

The aim of this study is to determine the proper initial dose adjustment when switching from multiple daily injections to continuous subcutaneous insulin infusion for type-1 diabetic pediatric patients. Our hypothesis is that the insulin adjustment varies depending on the pubertal status and the previous long-acting insulin used. Charts of 60 patients were reviewed. Data regarding insulin dose, type of insulin administrated, HbA1c, BMI, severe hypoglycemia and DKA events were collected during the previous year and after 6 weeks of pump therapy. In the prepubertal patients the reduction was 19% (26% if the previous insulin used was detemir). Pubertal patients experienced a decrease of 26%, and the detemir group 33%. The ratio long acting-basal/short acting-bolus insulin changed from 1.26 ± 0.84 to 0.93 ± 0.46 (P < 0.05). The total daily insulin dose needs to be decreased. Basal insulin constitutes 40-45% in prepubertal and 45-50% in pubertal patients. The reduction is different depending on the previous long-acting insulin used; being greater if the insulin is detemir.