Lessons Learned From a Pilot RCT of Simultaneous Versus Delayed Initiation of Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy

Abstract

Uncertainty remains about effectiveness of continuous glucose monitoring (CGM) in pediatric type 1 diabetes (T1D). Success with CGM is related to CGM adherence, which may relate to readiness to make the behavior changes required for effective use. We hypothesize that readiness for change will be greater at initiation of insulin pump therapy than in established pump users, and that this will predict CGM adherence. Our objective was to evaluate the feasibility of a randomized controlled trial (RCT) in children with established T1D comparing simultaneous pump and CGM initiation to standard pump therapy with delayed CGM initiation. We randomized participants to simultaneous pump and CGM initiation or to standard pump therapy with the option of adding CGM 4 months later. CGM adherence was tracked via web-based download and readiness for change assessed with the SOCRATES questionnaire. Of 41 eligible children, 20 agreed to participate; 15 subjects completed the study (7 males; baseline age 11.8 ± 4.0 years; T1D duration 2.7 ± 2.7 years; mean A1C 8.2 ± 0.8%). Six of 8 simultaneous group subjects used CGM > 60% of the time for 4 months compared to 1 of 7 delayed group subjects (P = .02). Using SOCRATES, we could assign 87-100% of subjects to a single motivation stage at baseline and 4 months. This pilot study demonstrates the feasibility of randomizing pump naïve children and adolescents with established T1D to simultaneous pump and CGM initiation versus standard pump therapy with delayed CGM initiation. Lessons from this pilot study were used to inform development of a full-scale multicenter RCT.

Adherence to Glycemic Monitoring in Diabetes

“…However, researchers still noted an overall decline in CGM use over time (mean use > 65% of the time during weeks 1-14 vs 36% of the time at the end of the study), suggesting additional strategies may be needed to help patients to maintain a higher rate of CGM use over the long term. 43 Research demonstrates that CGM has the potential to improve patients' HbA1c levels when used consistently. [30][31][32][33][34][35][36] However, several other studies report patients struggling with long-term adherence to this technology and problems with barriers to CGM use.…”

“…There is 1 published intervention that piloted simultaneous versus delayed initiation of CGM with continuous subcutaneous insulin infusion (CSII) in youths with T1DM. 43 The researchers hypothesized that patients would be more likely to adhere to using CGM consistently if the technology was introduced at the same time as CSII because patients would (1) see CGM as an integral part of optimal CSII management and (2) experience an easier time adopting CGM because they were already demonstrating a greater readiness for behavior change. Forty-one youths were randomly assigned to receive CGM plus CSII simultaneously or CSII with delayed CGM start.…”

Continuous Glucose Monitoring for Glycemic Control in Children and Adolescents Diagnosed with Diabetes Type 1: A Systematic Review and Meta-Analysis

“…Although the results for user satisfaction were contradictory, it is possible that the direction of effect for user satisfaction tended to indicate a benefit of CGM use. Results of the study that found an effect of CGM (Rubin et al [30]) should be given a higher weighting than the opposite findings by Olivier et al [29]. That is justified, because Rubin et al [30] included substantially more patients in the analysis (156 compared to 15) and had a longer follow-up time (12 months compared to four months) than did Olivier et al [29].…”

Psychosocial aspects of the usage of modern technologies in diabetes mellitus

“…Так, в обзоре Franklin отмечается, что 95% проблем, связанных с использованием помпы, обусловлено ошибками пациента [13]. Отмечается, что к числу факторов, способствующих повышению эффективности ППИИ, относится готовность к изменениям [29], уровень автономии [30], способность принятия на себя ответственности [31]. Выделяют также другие личностные особенности пациента -его эмоциональной сферы, самооценки, стратегий совладания и т.д.…”