Continuous glucose monitoring reduces both hypoglycaemia and HbA1c in hypoglycaemia-prone type 1 diabetic patients treated with a portable pump

Abstract

Aim. -This study aimed to assess the effectiveness of continuous glucose monitoring (CGM) for glucose control in type 1 diabetic patients treated by continuous subcutaneous insulin infusion (CSII) and presenting with frequent hypoglycaemic episodes.Methods. -Thirteen patients with type 1 diabetes (diabetes duration: 25 ± 15 years; CSII duration: 5.5 ± 7.0 years), with more than six recorded capillary blood glucose (CBG) values < 60 mg/dL, according to their metres for the past 14 days, were offered the permanent use of a CGM device (Guardian RT ® , Medtronic) plus ongoing self-monitoring of blood glucose (SMBG) for 12 weeks, followed by a 12-week crossover period of SMBG only, or vice versa. Glucose control, determined by recorded 14-day CBG values < 60 mg/dL and HbA 1c levels, and quality of life according to the Diabetes Quality of Life (DQOL) questionnaire, were assessed at baseline, and after 12-and 24-week follow-ups.Results. -Four patients withdrew from the study during the first period (of whom three were using CGM). In the nine study completers, the number of low CBG values decreased significantly from 13.9 ± 9.2 to 7.6 ± 6.8 (P = 0.011) when patients used CGM, in either the initial or final trial period, while a decrease in HbAi c from 8.3 ± 0.7 to 7.7 ± 0.6% (P = 0.049) was also observed, in contrast to the absence of any significant differences during the SMBG-only period. DQOL scores were also essentially unaffected.Conclusion. -This pilot observational study supports the hypothesis that CGM use can significantly improve overall glucose control while reducing hypoglycaemic episodes in hypoglycaemia-prone type 1 diabetic patients treated by CSII. Objectif. -Étudier l'efficacité d'un système de mesure continue du glucose sur le contrôle glycémique de patients diabétiques de type 1 traités par pompe portable à insuline et présentant des hypoglycémies fréquentes.Méthodes. -Treize patients diabétiques de type 1 (durée du diabète : 25 ± 15 années ; durée du traitement par pompe : 5,5 ± 7,0 années), présentant plus de six glycémies capillaires inférieures à 60 mg/dl enregistrées dans leur lecteur à mémoire durant les 14 derniers jours, ont participé à une étude observationnelle. Cette dernière comprenait deux périodes de 12 semaines en ordre croisé, avec soit le recours complémentaire à un système de monitoring du glucose (Guardian RT ® , Medtronic), soit seulement lapoursuite de l'autosurveillance glycémique habituelle. Le contrôle glycémique, évalué sur la base du nombre de glycémies capillaires inférieures à 60 mg/dl au cours des 14 derniers jours et du taux d'HbA 1c , et la qualité de vie ont été analysés à l'inclusion, après 12 semaines et après 24 semaines.Résultats. -Quatre patients se sont retirés de l'essai durant la première période (dont trois alors qu'ils étaient sous Guardian RT ® ). Chez les neuf patients ayant achevé l'étude, le nombre de valeurs glycémiques basses a diminué de 13,9 ± 9,2 à 7,6 ± 6,8 (p = 0,011) lorsque les patients utilisaient le Guardian RT ® , que ce soit en périod...

Methods for Insulin Delivery and Glucose Monitoring in Diabetes: Summary of a Comparative Effectiveness Review

“…58 Another study reported improvement on the Physical Component Score of the Short Form-12 favoring rt-CGM, but no difference was seen between the comparison arms on the Mental Component Score at 26 weeks (low strength of evidence). 65 No difference was found in the effects on diabetes-related quality of life in either of 2 studies comparing rt-CGM and SMBG (low strength of evidence), 57,65 while 1 study that reported effect on quality of life related to diabetes treatment demonstrated less fear of hypoglycemia with rt-CGM than with SMBG (insufficient strength of evidence). 65 None of the studies evaluated the comparative effectiveness of rt-CGM versus SMBG in terms of mortality, microvascular or macrovascular disease, weight, or any other process measure.…”

“…23,[57][58][59][60][61][62][63][64][65] The median follow-up time for all studies was 24 weeks, and median enrollment of 132 patients was reported in 6 studies. The mean age of participants was 24 years in the rt-CGM group and 25 years in the SMBG group, with mean baseline A1c of 8.3% in both groups.…”

“…23,[57][58][59][60][61][62][63][64] A second meta-analysis of 4 studies in children and adolescents age 18 years or younger also found a significant combined mean between-group difference in A1c from baseline in favor of rt-CGM (-0.26%; 95% CI, -0.46 to -0.06; P = 0.248; Figure 2). The difference was confirmed by a sensitivity subset analysis that demonstrated hypoglycemia, hyperglycemia, and weight gain among the studies.…”

Continuous Glucose Monitoring and Global Reimbursement: An Update

“…[14][15][16][17][18][19][20][21][22][23][24][25][26] The primary goal of most clinical studies of RT-CGM conducted to date has been to demonstrate that the technology significantly reduces HbA1c even though these devices also should decrease the risk of hypoglycemia, which is a major barrier to patients achieving glycemic targets. 27 Although several studies have shown that use of RT-CGM significantly reduces time spent in hypoglycemia in T1DM patients, 14,16,28 initial RCTs evaluating RT-CGM were not designed or adequately powered to determine the efficacy of RT-CGM for reducing the frequency of hypoglycemic events in general and severe hypoglycemic events in particular.…”

Real-time continuous glucose monitoring (CGM) integrated into the treatment of type 1 diabetes: Consensus of experts from SFD, EVADIAC and SFE

“…A study having as its principal objective the reduction of mild hypoglycaemias [35] demonstrates that the use of a CGM device for six months by patients with well-controlled type 1 diabetes (HbA 1c < 7.5%) treated by pump (the majority) or multiple injections makes possible a reduction by half of the time spent in hypoglycaemia (P = 0.03) and a supplementary improvement of HbA 1c (-0.27%, P = 0.0008) [35]. Another study recruited a small number of patients on the basis of frequency of hypoglycaemia (more than 6 episodes < 60 mg/ dl in the last 15 days) and showed a 50% reduction in the frequency of hypoglycaemias and a simultaneous reduction in HbA 1c when a CGM device as opposed to SBMG is used for three months [36].…”