The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus

Background:

Real-time continuous glucose monitoring (RT-CGM) improves hemoglobin A1c (A1C) and hypoglycemia in people with type 1 diabetes mellitus and those with type 2 diabetes mellitus (T2DM) on prandial insulin; however, it has not been tested in people with T2DM not taking prandial insulin. We evaluated the utility of RT-CGM in people with T2DM on a variety of treatment modalities except prandial insulin.

Methods:

We conducted a prospective, 52-week, two-arm, randomized trial comparing RT-CGM (n = 50) versus self-monitoring of blood glucose (SMBG) (n = 50) in people with T2DM not taking prandial insulin. Real-time continuous glucose monitoring was used for four 2-week cycles (2 weeks on/1 week off). All patients were managed by their usual provider. This article reports on changes in A1C 0–12 weeks.

Results:

Mean (±standard deviation) decline in A1C at 12 weeks was 1.0% (±1.1%) in the RT-CGM group and 0.5% (±0.8%) in the SMBG group (p = .006). There were no group differences in the net change in number or dosage of hypoglycemic medications. Those who used the RT-CGM for ≥48 days (per protocol) reduced their A1C by 1.2% (±1.1%) versus 0.6% (±1.1%) in those who used it <48 days (p = .003). Multiple regression analyses statistically adjusting for baseline A1C, an indicator for usage, and known confounders confirmed the observed differences between treatment groups were robust (p = .009). There was no improvement in weight or blood pressure.

Conclusions:

Real-time continuous glucose monitoring significantly improves A1C compared with SMBG in patients with T2DM not taking prandial insulin. This technology might benefit a wider population of people with diabetes than previously thought.     

Sodium‐glucose cotransporter 2 inhibitor luseogliflozin improves glycaemic control,assessed by continuous glucose monitoring,even on a low‐carbohydrate diet

This randomized, double‐blind, placebo‐controlled, crossover study was the first to determine the effects of luseogliflozin in combination with a low‐carbohydrate diet (LCD) on 24‐h glucose variability, assessed by continuous glucose monitoring (CGM). A total of 18 Japanese patients with type 2 diabetes were randomized into two groups, in which patients first received luseogliflozin 2.5 mg once daily then placebo for 8 days each, or vice versa. Patients took luseogliflozin or placebo with a normal‐carbohydrate diet (NCD) on day 7 and with the LCD on day 8. CGM was performed on both days. Luseogliflozin significantly reduced glucose exposure in terms of the area under the curve over the course of 24 h when administered with the NCD (difference vs placebo: ?555.6 mg/dl·h [1 mg/dl = 0.0556 mmol/l]; p < 0.001) or with the LCD (?660.7 mg/dl·h; p < 0.001). No hypoglycaemia was observed over 24 h with either diet. Although glucose levels were lower with the LCD than with the NCD in the placebo treatment period, luseogliflozin with the LCD improved glycaemic control throughout the day to nearly the same extent as luseogliflozin with the NCD, without inducing hypoglycaemia.     

Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes

Continuous and flash glucose monitoring (GM) systems have been established in diabetes care. We compared the sensor performance of 3 commercially available GM systems. A total of 12 patients with type 1 diabetes were included in a single‐centre, open‐label study in which the sensor performance of the Abbott FreeStyle libre (Abbott), Dexcom G4 Platinum (Dexcom) and Medtronic MiniMed 640G (Medtronic) systems over 12 hours was compared during mimicked real‐life conditions (meals, exercise, hypo‐ and hyperglycaemia). Sensor performance was determined by fulfilment of ISO 15197:2013 criteria, calculating mean absolute relative difference (MARD), and was also illustrated using Parkes error grid and Bland–Altman plots. Sensor performance during changes in metabolic variables (lactate, betahydroxybutyrate, glucagon, non‐esterified‐fatty‐acids) was determined by Spearman's rank correlation coefficient testing. The systems fulfilled ISO 15197:2013 criteria by 73.2% (Abbott), 56.1% (Dexcom) and 52.0% (Medtronic). The MARDs ± standard deviation in the entire glycaemic range were 13.2% ± 10.9% (Abbott), 16.8% ± 12.3% (Dexcom) and 21.4% ± 17.6% (Medtronic), respectively. All sensors performed less accurately during hypoglycaemia and best during hyperglycaemia. We did not observe an influence of metabolic variables on sensor performance.     

Effect of short-term use of a continuous glucose monitoring system with a real-time glucose display and a low glucose alarm on incidence and duration of hypoglycemia in a home setting in type 1 diabetes mellitus

Background

The objective of this study was to examine whether setting the low glucose alarm of a Guardian^® REAL-Time continuous glucose monitoring system (CGMS) to 80 mg/dl for 3 days and providing instructions to users reduce the risk of hypoglycemia under free-living conditions in individuals with type 1 diabetes mellitus (T1DM).

Methods

Fourteen participants with T1DM aged 26.1 ± 6.0 years (mean ± standard deviation) were fitted with a CGMS and assigned for 3 days to either an alarm [low and high blood glucose (BG) alarms set at 80 and 200 mg/dl, respectively] or no alarm condition, with each treatment administered to all participants following a counterbalanced design. All participants were given detailed instructions on how to respond appropriately to low glucose alarms.

Results

The CGMS with alarm reduced the incidence of hypoglycemia (CGMS readings ≤65 mg/dl) by 44% as well as the time spent below this hypoglycemic threshold by 64% without increasing average BG levels. However, the CGMS with alarm had no effect on the incidence of symptomatic hypoglycemia.

Conclusions

Short-term use of the CGMS with alarm, together with appropriate instructions for users, reduces the incidence and duration of hypoglycemia, but only to a limited extent, in part because it overestimates BG in the low glucose range.     

Professional continuous glucose monitoring in patients with diabetes mellitus: A systematic review and meta-analysis

Aim

To evaluate the effect on glucose control of professional continuous glucose monitoring (p-CGM)-based care as compared with standard care in the management of patients with type 1 and type 2 diabetes.

Materials and methods

The PubMed database was searched comprehensively to identify prospective or retrospective studies evaluating p-CGM as a diagnostic tool for subsequent implementation of lifestyle and/or medication changes and reporting glycated haemoglobin (HbA1c) as an outcome measure.

Results

We found 872 articles, 22 of which were included in the meta-analysis. Overall, the use of p-CGM was associated with greater HbA1c reduction from baseline (−0.28%, 95% confidence interval [CI] −0.36% to −0.21%, I² = 0%, P < 0.00001) than usual care, irrespective of type of diabetes, length of follow-up, frequency of continuous glucose monitoring (CGM) use and duration of CGM recording. In the few studies describing CGM-derived glucose metrics, p-CGM showed a beneficial effect on change in time in range from baseline (5.59%, 95% CI 0.12 to 11.06, I² = 0%, P = 0.05) and a neutral effect on change in time below the target range from baseline (−0.11%, 95% CI −1.76% to 1.55%, I² = 33%, P = 0.90).

Conclusions

In patients with type 1 and type 2 diabetes, p-CGM-driven care is superior to usual care in improving glucose control without increasing hypoglycaemia.     

Cost-utility of real-time continuous glucose monitoring versus self-monitoring of blood glucose and intermittently scanned continuous glucose monitoring in people with type 1 diabetes receiving multiple daily insulin injections in Denmark

Aims

To determine the cost-effectiveness of the Dexcom G6 real-time continuous glucose monitoring (rt-CGM) system compared with both the self-monitoring of blood glucose (SMBG) and the Abbott FreeStyle Libre 1 and 2 intermittently scanned CGM (is-CGM) devices in people with type 1 diabetes receiving multiple daily insulin injections in Denmark.

Materials and Methods

The analysis was performed using the IQVIA Core Diabetes Model, which associates rt-CGM use with glycated haemoglobin reductions of 0.6% and 0.36% based on data from the DIAMOND and ALERTT1 trials, respectively, compared with SMBG and is-CGM use. The analysis was performed from the payer perspective over a 50-year time horizon; future costs and clinical outcomes were discounted at 4% per annum.

Results

The use of rt-CGM was associated with an incremental gain of 1.37 quality-adjusted life years (QALYs) versus SMBG. Total mean lifetime costs were Danish Krone (DKK) 894 535 for rt-CGM and DKK 823 474 for SMBG, resulting in an incremental cost-utility ratio of DKK 51 918 per QALY gained versus SMBG. Compared with is-CGM, the use of rt-CGM led to a gain of 0.87 QALYs and higher mean lifetime costs resulting in an incremental cost-utility ratio of DKK 40 879 to DKK 34 367 per QALY gained.

Conclusions

In Denmark, the rt-CGM was projected to be highly cost-effective versus both SMBG and is-CGM, based on a willingness-to-pay threshold of 1× per capita gross domestic product per QALY gained. These findings may help inform future policies to address regional disparities in access to rt-CGM.     

A low-GI diet is associated with a short-term improvement of glycaemic control in Asian patients with type 2 diabetes

Aims: The aim of this study is to compare the efficacy of low glycaemic index (GI) vs. conventional carbohydrate exchange (CCE) dietary advice on glycaemic control and metabolic parameters in patients with type 2 diabetes. Methods: A total of 104 patients with type 2 diabetes were randomly assigned to either a low GI (GI) or CCE dietary advice over a 12‐week period. The primary end‐point was glycaemic control as assessed by glycated haemoglobin A_1c (HbA_1c), fructosamine level and plasma glucose. The secondary end‐points were anthropometric measurements and metabolic parameters that include blood pressure, lipid profile and insulin levels. The oral antidiabetic medications remained unchanged throughout the duration of the study. Results: A low‐GI diet was associated with significant changes in the fructosamine level (ΔGI = ?0.20 ± 0.03; ΔCCE = ?0.08 ± 0.03 mmol/l, p < 0.01) and waist circumference (ΔGI group = ?1.88 ± 0.30 cm; ΔCCE group: ?0.36 ± 0.4 cm, p < 0.05) at week 4. At week 12, the changes in fasting glucose (ΔGI = ?0.03 ± 0.3; ΔCCE = 0.7 ± 0.3 mmol/l; p < 0.05) and waist circumference (ΔGI = ?2.35 ± 0.47 cm; ΔCCE group = ?0.66 ± 0.46 cm; p < 0.05) in the GI group was significantly lower than the CCE group. With the low‐GI diet, the changes in postprandial glycaemia at time 0, 60, 150 and 180 min after consuming the standard test meal was lower than with the CCE diet (p < 0.05). No significant differences were found between the groups for the remaining parameters that were measured. Conclusions: Use of a low‐GI diet resulted in significant changes of serum fructosamine level, plasma glucose and waist circumference in Asian patients with type 2 diabetes over a 12‐week period compared with those following a CCE diet. The effect on HbA_1c and other metabolic parameters was not significantly different between the two study groups but the improvement within the GI group was more pronounced and of clinical benefit.     

动态血糖监测甘精胰岛素治疗老年2型糖尿病的研究

目的通过动态血糖监测（CGMS），评估甘精胰岛素治疗老年2型糖尿病（T2DM）的疗效和安全性。方法对39例口服药联合治疗空腹血糖控制不佳的老年T2DM患者，加用甘精胰岛素（IG）和中性鱼精蛋白锌胰岛素（NPH）睡前皮下注射，治疗12周。治疗前后测定空腹血糖（FPG）、餐后2h血糖（2hPG）、糖化血红蛋白（HbAlc）、空腹C肽及餐后2hC肽等，并进行比较。结果治疗后，2组血糖和HbAlc均较治疗前下降（P〈0．05或P〈0．01），IG组血糖下降更明显（P〈0．05），2组HbAlc无明显差异（P〉0．05），IG组治疗后餐后2hC肽水平提高（P〈0．05）。CGMS显示IG组24h血糖曲线平缓，血糖达标时间延长，夜间低血糖的发生率低（P〈0．01）．血糖波动幅度小。结论IG作为老年T2DM患者的基础胰岛素替代治疗，血糖控制达标率高，胰岛素剂量控制更方便、安全，优于NPH。