Early identification of children with type 1 diabetes mellitus presenting to hospital with diabetic ketoacidosis: a pilot study
CCCF ePoster library. Klowak J. Oct 2, 2017; 198187; 27
Dr. Jennifer Klowak
Dr. Jennifer Klowak
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Early identification of children with type 1 diabetes mellitus presenting to hospital with diabetic ketoacidosis: a pilot study

Klowak, Jennifer A.1, Shen, Julia W.1, Aguirre, Emilio1, Kam, April J.1,2,6, Samaan, Constantine M.1,3,6 and Parker, Melissa J.1,4,5,6,7

1Department of Pediatr

Introduction: Pediatric diabetic ketoacidosis (DKA) is a common, life-threatening, metabolic emergency that can complicate type one diabetes mellitus (DM1). Many aspects of DKA emergency treatment are not supported by high-level evidence and few randomized controlled trials (RCTs) have been done in this population. Studying time-sensitive emergency interventions can be challenging due to the need to rapidly identify and enrol potential participants. We conducted a pilot study to explore feasibility considerations and inform planning of a future RCT.
Objectives: Our primary objectives were to determine the feasibility of an RCT of children with DM1 and DKA based on: 1. Timely identification of eligible participants by the research team, 2. Ability to obtain consent for data collection.  We also sought to evaluate a variety of study process feasibility metrics and to characterize current DKA treatment practices.
Design: Prospective observational pilot study. Setting: McMaster Children’s Hospital (MCH).  Timeframe: 6 months (01/01/2016 to 31/08/2016). Participants: Children 0-17 yrs of age with known or suspected DM1 who met DKA diagnostic criteria and were expected to require/required hospital admission. Recruitment: The study was promoted to the Pediatric Emergency Medicine, Pediatric Critical Care, and Pediatric Endocrinology services. Healthcare providers were asked to page the research team for any DKA case presenting for treatment. The PICU was also screened on weekdays to identify any potential participant for whom the research team was not paged.  Eligible participants and/or their substitute decision-makers (SDM) were approached for consent. Consenting participants or their SDM were asked a scripted hypothetical question regarding willingness to consent to a future interventional study. Ethics: Study conduct was approved by the Hamilton Integrated Research Ethics Board (Project #1201). Data: Demographic, treatment and laboratory data were abstracted from medical records and entered into the REDCap database. Analysis: We used descriptive statistics to summarize our data. Analysis of primary outcomes was by calculation of simple proportions and associated 95% confidence intervals.  An 80% pass threshold for research team notification and consent rate were selected a priori for feasibility determination.
Results: Twenty-eight children were screened over the study period with 25 eligible for inclusion. The research team was notified for 20/25 [80%; 95% CI: 59-93%] eligible individuals.  Consent was obtained for 23/25 [92%; 95% CI: 74-99%]. Mean (sd) age of study participants was 10.8 (+/- 4.8) yrs and 13/23 (57%) were male. Forty-eight percent (11/23) were transferred to MCH after first presenting to another hospital while 19/23 (83%) were admitted to PICU. Starting insulin infusion rate was variable with 65% (15/23) receiving 0.1 U/kg/hr, 30% (7/23) receiving 0.05 U/kg/hr, and 4% (1/23) receiving 0.8 U/kg/hr. Ninety-six percent (22/23) of children received a 0.9% normal saline IV fluid bolus at treatment initiation. All survived to hospital discharge.  Of consenting participants or their decision makers, 100% (23/23) indicated they would consider participating in a future trial evaluating IV fluid therapy in the treatment of DKA.
Conclusion: We demonstrate feasibility of early identification and consent for children presenting with DKA and DM1.  A future interventional trial appears feasible.

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