Clinical Application of Emerging Sensor Technologies in Diabetes Management: Consensus Guidelines for Continuous Glucose Monitoring (CGM)

Hirsch, Irl B.; Armstrong, Dana; Bergenstal, Richard M.; Buckingham, Bruce A.; Childs, Belinda P.; Clarke, William L.; Peters, Anne L.; Wolpert, Howard

doi:10.1089/dia.2008.0016

Cited by 122 publications

(89 citation statements)

References 29 publications

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“…Insulin doses were increased for arrows going up and decreased for arrows going down as clinically indicated. 9 Finally, each period was simulated five times to present several random sensor profiles to each observed clinical situation, leading to 10,410 episodes for each noise level using each treatment modality with and without trend arrows, for a total of 437,220 simulations.…”

Section: Replay Of Observed Treatment Scenariosmentioning

confidence: 99%

“…Since the advent of CGM technology, 1-3 significant progress has been made toward versatile and reliable devices that not only approximate the course of blood glucose (BG) fluctuations day and night, but also provide feedback such as alarms when preset low or high thresholds are reached. Several studies have documented the benefits of CGM [4][5][6][7] and charted guidelines for its clinical use 8,9 and for its future as a base for closed-loop control. 10,11 Physiology and CGM errors…”

Section: Introductionmentioning

confidence: 99%

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Assessing Sensor Accuracy for Non-Adjunct Use of Continuous Glucose Monitoring

Kovatchev

Patek

Ortiz

et al. 2015

Diabetes Technology & Therapeutics

184

154

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Background: The level of continuous glucose monitoring (CGM) accuracy needed for insulin dosing using sensor values (i.e., the level of accuracy permitting non-adjunct CGM use) is a topic of ongoing debate. Assessment of this level in clinical experiments is virtually impossible because the magnitude of CGM errors cannot be manipulated and related prospectively to clinical outcomes. Materials and Methods: A combination of archival data (parallel CGM, insulin pump, self-monitoring of blood glucose [SMBG] records, and meals for 56 pump users with type 1 diabetes) and in silico experiments was used to ''replay'' real-life treatment scenarios and relate sensor error to glycemic outcomes. Nominal blood glucose (BG) traces were extracted using a mathematical model, yielding 2,082 BG segments each initiated by insulin bolus and confirmed by SMBG. These segments were replayed at seven sensor accuracy levels (mean absolute relative differences [MARDs] of 3-22%) testing six scenarios: insulin dosing using sensor values, threshold, and predictive alarms, each without or with considering CGM trend arrows. Results: In all six scenarios, the occurrence of hypoglycemia (frequency of BG levels £ 50 mg/dL and BG levels £ 39 mg/dL) increased with sensor error, displaying an abrupt slope change at MARD = 10%. Similarly, hyperglycemia (frequency of BG levels ‡ 250 mg/dL and BG levels ‡ 400 mg/dL) increased and displayed an abrupt slope change at MARD = 10%. When added to insulin dosing decisions, information from CGM trend arrows, threshold, and predictive alarms resulted in improvement in average glycemia by 1.86, 8.17, and 8.88 mg/dL, respectively. Conclusions: Using CGM for insulin dosing decisions is feasible below a certain level of sensor error, estimated in silico at MARD = 10%. In our experiments, further accuracy improvement did not contribute substantively to better glycemic outcomes.

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Section: Replay Of Observed Treatment Scenariosmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Assessing Sensor Accuracy for Non-Adjunct Use of Continuous Glucose Monitoring

Kovatchev

Patek

Ortiz

et al. 2015

Diabetes Technology & Therapeutics

184

154

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“…Permanent use of the Guardian RT device for 3 months significantly improved HbA 1c levels compared with SMBG, while intermittent CGM use showed no significant benefit [6]. The recent Juvenile Diabetes Research Foundation (JDRF) trial reported that CGM for 6 months led to significant HbA 1c improvement vs SMBG use only in young patients who showed good compliance with sensor use [16], although the incidence of severe or biochemical hypoglycaemic events was not significantly altered.…”

Section: Discussionmentioning

confidence: 99%

“…Nevertheless, the increasing availability of continuous glucose monitoring (CGM) is helpful in detecting hyperand hypoglycaemic deviations that might otherwise go unrecognized with self-monitoring of blood glucose (SMBG) only [6]. Until now, the demonstrated benefits of CGM have focused on reducing HbA 1c in patients who were far from achieving their targeted HbA 1c levels [7,8], while outcomes of CGM use on the occurrence of hypoglycaemia have been poorly investigated and for short time-periods only [9].…”

Section: Introductionmentioning

confidence: 99%

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

Radermecker¹,

Remy²,

Scheen³

et al. 2010

Diabetes & Metabolism

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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...

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“…Indeed, the "gold standard" is considered the mean amplitude of glycemic excursions (MAGE) value which is obtained by measuring the arithmetic mean of the differences between consecutive peaks and nadirs with a measurement in the peaks-to-nadir direction by the first qualifying excursion (Monnier et al 2007). MAGE estimation requires the use of new devices allowing continuous glucose monitoring on ambulatory basis (Hirsch et al 2008).…”

mentioning

confidence: 99%

Short-term effects of low-dose estrogen/drospirenone vs low-dose estrogen/dydrogesterone on glycemic fluctuations in postmenopausal women with metabolic syndrome

Rizzo

Leo

Franciscis

et al. 2013

AGE

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This study aims to compare the effects of low-dose emidrate estradiol/drospirenone (E2/DRSP) vs low-dose emidrate estradiol/dydrogesterone (E2/DG) combination on the mean amplitude of glycemic excursions (MAGE) value in postmenopausal women affected by metabolic syndrome (MS). One hundred sixty postmenopausal women were recruited to receive a treatment with oral doses of E2/1 mg plus drospirenone/2 mg (E2/DRSP group) or oral dose of E2/1 mg plus dydrogesterone/5 mg (E2/DG group) for 6 months. At enrollment and after 6 months, anthropometric, metabolic, and inflammatory parameters have been assessed. MAGE, evaluated during 48-h continuous subcutaneous glucose monitoring (CSGM), allowed us to assess daily glucose fluctuations at baseline and after 6 months. After hormone therapy, both groups showed a significant decline in fasting plasma glucose levels (p<0.05), while only E2/DRSP group showed a statistically significant decline in waist circumferences, post-prandial glycemia, LDL, plasma triglycerides, MAGE, HOMA index, and plasma IL-6 (p<0.05) levels. In the whole population (n=160), after 6 months of indicated therapy, changes in fasting plasma glucose and PAI-1 levels correlated with the changes in MAGE values, while only in E2/DRSP group that MAGE reduction was positively associated with a stronger decrease in waist circumferences, triglycerides, and TNF-α plasma levels. The independent effect of hormone therapy (HT) on reduction in MAGE value has been tested in three different multiple linear regression models. HT resulted to be associated with MAGE, independent of other confounding variables. Although both groups had a decline in fasting plasma glucose, only drospirenone treatment revealed positive effects on glycemic excursions and insulin sensitivity, induced favorable changes in lipid profile, and showed an improvement of inflammatory indices in postmenopausal women with MS.

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Clinical Application of Emerging Sensor Technologies in Diabetes Management: Consensus Guidelines for Continuous Glucose Monitoring (CGM)

Cited by 122 publications

References 29 publications

Assessing Sensor Accuracy for Non-Adjunct Use of Continuous Glucose Monitoring

Assessing Sensor Accuracy for Non-Adjunct Use of Continuous Glucose Monitoring

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

Short-term effects of low-dose estrogen/drospirenone vs low-dose estrogen/dydrogesterone on glycemic fluctuations in postmenopausal women with metabolic syndrome

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