Impact of ELKa, the Electronic Device for Prandial Insulin Dose Calculation, on Metabolic Control in Children and Adolescents with Type 1 Diabetes Mellitus: A Randomized Controlled Trial

Abstract

Background. The ELKa system is composed of computer software, with a database of nutrients, and a dedicated USB kitchen scale. It was designed to automatize the everyday calculations of food exchanges and prandial insulin doses. Aim. To investigate the influence of the ELKa on metabolic control in children with type 1 diabetes mellitus (T1DM). Methods. A randomized, parallel, open-label clinical trial involved 106 patients aged <18 years with T1DM, HbA1C ≤ 10%, undergoing intensive insulin therapy, allocated to the intervention group, who used the ELKa (n = 53), or the control group (n = 53), who used conventional calculation methods. Results. After the 26-week follow-up, the intention-to-treat analysis showed no differences to all endpoints. In per protocol analysis, 22/53 (41.5%) patients reporting ELKa usage for >50% of meals achieved lower HbA1C levels (P = 0.002), lower basal insulin amounts (P = 0.049), and lower intrasubject standard deviation of blood glucose levels (P = 0.023) in comparison with the control. Moreover, in the intervention group, significant reduction of HbA1C level, by 0.55% point (P = 0.002), was noted. No intergroup differences were found in the hypoglycemic episodes, BMI-SDS, bolus insulin dosage, and total daily insulin dosage. Conclusions. The ELKa system improves metabolic control in children with T1DM under regular usage. The trial is registered at ClinicalTrials.gov, number NCT02194517.

SKIP (Supporting Kids with diabetes In Physical activity): Feasibility of a randomised controlled trial of a digital intervention for 9-12 year olds with type 1 diabetes mellitus

“…Given the child’s clinic was the key setting, there is reason to believe that similar approaches could be used to increase engagement with research in other paediatric populations with chronic conditions [22, 23]. Although the completion rate for full clinical data fell below pre-determined acceptability and feasibility targets at all time-points, completion rates were in line with other similar studies [24, 25]. The challenges for clinical data collection were largely related to accessing records for insulin dose, whereas collection of HbA1c and calculation of BMI was less problematic.…”

Telemedicine in Improving Glycemic Control Among Children and Adolescents With Type 1 Diabetes Mellitus: Systematic Review and Meta-Analysis

“…Eighteen studies were parallel group RCTs [31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48], and two were crossover studies [49,50]. Of the 20 included studies, 12 were published after 2015.…”

“…Of the 20 included studies, 12 were published after 2015. Eight studies were published in North America (40%) [31-34, 37, 39, 40, 44], seven studies were published in Europe (35%) [35,36,43,[45][46][47]49], four studies were published in Asia (20%) [38,42,48,50], one study was published in Oceania [41].…”

“…The communication technologies used in the telemedicine interventions we included in the various studies took a variety of forms. Patients initiated communication with healthcare providers through different forms of telemedicine: smart wearable device (30%; n=6) [33,36,42,44,45,50], smartphone application (25%; n=5) [32,34,[46][47][48], modem (15%; n=3) [31,37,39], online website (15%; n=3) [38,40,43], telephone (10%; n=2) [41,49] and unclear (5%; n=1) [35]. Healthcare providers initiated communication with patients through different forms of telemedicine: smartphone application (25%;…”

“…n=3) [43][44][45], telephone (15%; n=3) [31,38,41], SMS (15%; n=3) [32,34,35], computer software (10%; n=2) [36,39] or smart wearable device (5%; n=1) [42].…”