Short-term continuous glucose monitoring: effects on glucose and treatment satisfaction in patients with type 1 diabetes mellitus; a randomized controlled trial

Abstract

Objective: To assess whether 4 week's use of a continuous glucose monitoring (CGM) system improves glucose control, treatment satisfaction or health status, as compared to intensified conventional finger-prick measurements (ICFM) in patients with type 1 diabetes mellitus (DM1). Method: Thirty patients suffering from DM1 for more than three years and treated with either insulin pumps or multiple daily insulin injections, were included in a randomised controlled cross-over trial. They were Caucasians of both genders, between 18 and 50 years, and had moderately well controlled diabetes. The participants performed either ICFM or CGM for 4 weeks, followed by an 8 week's observation period. Thereafter they were crossed over to the opposite intervention. HbA(1c) , hypoglycaemic episodes, treatment satisfaction and health status were assessed at all meetings, although HbA(1c) was the primary endpoint. Results: At inclusion mean HbA(1c) was 7.8 ± 0.9 %. The mean change in HbA(1c) was -0.2 ± 0.1% and -0.2 ± 0.1% for the CGM and the ICFM periods, accordingly (p = 0.91). The mean changes in HbA(1c) during the combined treatment and observation periods were -0.1 ± 0.1% and -0.2 ± 0.1% for the CGM and the ICFM period, accordingly (p = 0.86). The frequency of severe hypoglycaemic episodes, treatment satisfaction and health status was also equal between the two interventions. No adverse events were observed.

Effectiveness of continuous glucose monitoring in maintaining glycaemic control among people with type 1 diabetes mellitus: a systematic review of randomised controlled trials and meta-analysis

“…The characteristics of the 22 included studies involving 2188 participants are summarised in Table 1. Seven studies were crossover designs [39][40][41][42][43][44][45]. The remaining 15 studies were parallelgroup designs.…”

“…Sample size varied from 20 [44,46] to 241 [47] participants. Participants' mean baseline HbA 1c was either ≤64 mmol/ mol (≤8%) (n = 8) [39,40,47,[55][56][57][58]60] or >64 mmol/mol (>8%) (n = 11) [41,42,44,46,[48][49][50][51][52][53]59]. Three studies did not report participant's baseline HbA 1c [43,45,54].…”

“…Study duration was <8 weeks (n = 3) [40, 51, 57], 14-16 weeks (n = 5) [39,43,45,46,48] and >24 weeks (n = 13). Duration of diabetes was <10 years (n = 6) [46, 50-52, 56, 57], 10 years to <20 years (n = 4) [39,40,48,59], 20 years to <30 years (n = 5) [41,47,49,55,58] and ≥30 years (n = 2) [53,60]. Five studies did not report duration of diabetes [42][43][44][45]54].…”

Russian national guidelines on insulin pump therapy and continuous glucose monitoring for diabetes mellitus patients. DRAFT

“…Достоверное улучше-ние показателей самоконтроля гликемии происходит только если пациент применяет НМГ-РВ в течение 6 дней и более в течение каждой недели (практически постоянно). Краткосрочное использование НМГ-РВ не оказывает значимого влияния на результаты кон-троля гликемии (Класс I; Уровень А) [56,59,60].…”

Continuous monitoring of blood glucose in the practice of endocrinologist

“…В другом ис-следовании было показано, что даже непрерывное использование CGM-RT, но в течение только 4 недель, не оказывает существенного влияния на результаты контроля гликемии [16].…”