Continuous glucose monitoring (CGM) holds potential as a precision public health intervention, offering personalised insights into how diet and physical activity affect glucose levels. Nevertheless, the efficacy of using CGM in populations with and without diabetes to support behaviour change and behaviour-driven outcomes remains unclear. This systematic review and meta-analysis examines whether using CGM-based feedback to support behaviour change affects glycaemic, anthropometric, and behavioural outcomes in adults with and without diabetes.

Ovid MEDLINE, Cochrane Central Register of Controlled Trials, Elsevier Embase, EBSCOhost PsycINFO, and ProQuest Dissertations & Theses Global were searched through January 2024. Eligible studies were randomised controlled trials in adults that implemented CGM-based feedback in at least one study arm compared to a control without CGM feedback. Dual screening, data extraction, and bias assessment were conducted independently. Mean differences in outcomes between intervention and comparison groups were analysed using generic inverse variance models and random effects. Robustness of pooled estimates from random-effects models was considered with sensitivity and subgroup analyses.

Twenty-five clinical trials with 2996 participants were included. Most studies were conducted in adults with type 2 diabetes (n = 17/25; 68%), followed by type 1 diabetes (n = 3/25, 12%), gestational diabetes (n = 3/25, 12%), and obesity (n = 3/25, 12%). Eleven (44%) studies reported CGM-affiliated conflicts of interest. Interventions incorporating CGM-based feedback reduced HbA1c by 0.28% (95% CI 0.15, 0.42, p < 0.001; I2 = 88%), and increased time in range by 7.4% (95% CI 2.0, 12.8, p < 0.008; I2 = 80.5%) compared to arms without CGM, with non-significant effects on time above range, BMI, and weight. Sensitivity analyses showed consistent mean differences in HbA1c across different conditions, and differences between subgroups were non-significant. Only 4/25 studies evaluated the effect of CGM on dietary changes; 5/25 evaluated physical activity.

This evidence synthesis found favourable, though modest, effects of CGM-based feedback on glycaemic control in adults with and without diabetes. Further research is needed to establish the behaviours and behavioural mechanisms driving the observed effects across diverse populations.

CRD42024514135.

Amidst the escalating prevalence of glucose-related chronic diseases, the advancements, potential uses, and growing accessibility of continuous glucose monitors (CGM) have piqued the interest of healthcare providers, consumers, and health behaviour researchers. Yet, there is a paucity of literature characterising the use of CGM in behavioural intervention research. This scoping review aims to describe targeted populations, health behaviours, health-related outcomes, and CGM protocols in randomised controlled trials (RCTs) that employed CGM to support health behaviour change.

We searched Ovid MEDLINE, Elsevier Embase, Cochrane Central Register of Controlled Trials, EBSCOhost PsycINFO, and ProQuest Dissertations & Theses Global from inception to January 2024 for RCTs of behavioural interventions conducted in adults that incorporated CGM-based biological feedback. Citation searching was also performed. The review protocol was registered ( https://doi.org/10.17605/OSF.IO/SJREA ).

Collectively, 5389 citations were obtained from databases and citation searching, 3995 articles were screened, and 31 were deemed eligible and included in the review. Most studies (n = 20/31, 65%) included adults with type 2 diabetes and reported HbA1c as an outcome (n = 29/31, 94%). CGM was most commonly used in interventions to target changes in diet (n = 27/31, 87%) and/or physical activity (n = 16/31, 52%). 42% (n = 13/31) of studies provided prospective CGM-based guidance on diet or activity, while 61% (n = 19/31) included retrospective CGM-based guidance. CGM data was typically unblinded (n = 24/31, 77%) and CGM-based biological feedback was most often provided through the CGM and two-way communication (n = 12/31, 39%). Communication typically occurred in-person (n = 13/31, 42%) once per CGM wear (n = 13/31; 42%).

This scoping review reveals a predominant focus on diabetes in CGM-based interventions, pointing out a research gap in its wider application for behaviour change. Future research should expand the evidence base to support the use of CGM as a behaviour change tool and establish best practices for its implementation.

doi.org/10.17605/OSF.IO/SJREA.

To provide a systematic review and meta-analysis synthesizing the findings of randomized controlled trials (RCTs) of continuous glucose monitors (CGMs) in the management of adults with type 2 diabetes mellitus (T2DM) on glucose control and clinical outcomes.

MEDLINE, Embase, and Cochrane were searched for RCTs that assessed the effectiveness of real-time CGM (rt-CGM) or flash CGM (FGM) in adults (≥18 years) with T2DM that reported on at least 1 of the following outcomes: hemoglobin A1c (HbA1c), time in range, time in hyperglycemia, or time in hypoglycemia. The GRADE approach was used to assess certainty of evidence for primary outcomes.

Fourteen RCTs assessing CGM were included, with 825 patients in 9 RCTs using rt-CGM and 822 in 5 RCTs using FGM. Moderate certainty of evidence indicated that use of CGM had a modest but statistically significant reduction in HbA1c levels of about 0.32%. Our analyses of each device type separately showed similar reductions in HbA1c (0.34% and 0.33%, respectively, for rt-CGM and FGM), with trends for improvement in other glucose metrics favoring rt-CGM over self-monitored blood glucose.

Both rt-CGM and flash CGM led to modest but statistically significant declines in HbA1c among individuals with T2DM, with little heterogeneity in the results. However, the duration of the included RCTs was relatively short and few studies reported on important clinical outcomes, such as adverse events, emergency department use, or hospitalization. Longer term studies are needed to determine if the short-term improvements in glucose control leads to improvements in clinically important outcomes.

As the prevalence of diabetes is rapidly increasing, the use of continuous glucose monitoring, which is effective in improving glycemic control in type 2 diabetes, is increasing.

Systematic review was performed according to PRISMA criteria. The search was conducted for articles published until 31 May 2023 in PubMed, CINAHL, Cochrane Library, EMBASE, ClinicalKey, etc. The meta-analysis involved the synthesis of effect size; tests of homogeneity and heterogeneity; trim and fill plot; Egger's regression test; and Begg's test for assessing publication bias.

491 studies were searched, of which 17 studies that met the selection criteria were analyzed. The overall effect on HbA1c was -0.37 (95% CI, -0.63~-0.11, p < 0.001), with HbA1c decreasing significantly after CGM interventions. Sub-analyses showed that the study was statistically significant in those aged 60 years or older, when rt-CGM was used and when the study was performed in multiple centers.

The results of this study showed that intervention using CGM was effective in reducing HbA1c in type 2 diabetes. The factors identified in this study can be used as guidelines for developing future CGM intervention programs.

Glucose and insulin metabolism are altered in hemodialysis patients, and diabetes management is difficult in these patients. We aimed to validate flash glucose monitoring (FGM) in hemodialysis patients with and without diabetes mellitus as an attractive option for glucose monitoring not requiring regular self-punctures.

We measured interstitial glucose using a FreeStyle Libre device in eight hemodialysis patients with and seven without diabetes mellitus over 14 days and compared the results to simultaneously performed self-monitoring of capillary blood glucose (SMBG).

In 720 paired measurements, mean flash glucose values were significantly lower than self-measured capillary values (6.17±2.52 vs. 7.15±2.41 mmol/L, p=1.3 E-86). Overall, the mean absolute relative difference was 17.4%, and the mean absolute difference was 1.20 mmol/L. The systematic error was significantly larger in patients without vs. with diabetes (- 1.17 vs. - 0.82 mmol/L) and on dialysis vs. interdialytic days (-1.09 vs. -0.90 mmol/L). Compared to venous blood glucose (72 paired measurements), the systematic error of FGM was even larger (5.89±2.44 mmol/L vs. 7.78±7.25 mmol/L, p=3.74E-22). Several strategies to reduce the systematic error were evaluated, including the addition of +1.0 mmol/L as a correction term to all FGM values, which significantly improved accuracy.

FGM systematically underestimates blood glucose in hemodialysis patients but, taking this systematic error into account, the system may be useful for glucose monitoring in hemodialysis patients with or without diabetes.

Hypoglycemia in people with diabetes is common, especially in those taking medications such as insulin and sulfonylureas (SU) that place them at higher risk. Hypoglycemia is associated with distress in those with diabetes and their families, medication nonadherence, and disruption of life and work, and it leads to costly emergency department visits and hospitalizations, morbidity, and mortality.

To review and update the diabetes-specific parts of the 2009 Evaluation and Management of Adult Hypoglycemic Disorders: Endocrine Society Clinical Practice Guideline and to address developing issues surrounding hypoglycemia in both adults and children living with diabetes. The overriding objectives are to reduce and prevent hypoglycemia.

A multidisciplinary panel of clinician experts, together with a patient representative, and methodologists with expertise in evidence synthesis and guideline development, identified and prioritized 10 clinical questions related to hypoglycemia in people living with diabetes. Systematic reviews were conducted to address all the questions. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make recommendations.

The panel agreed on 10 questions specific to hypoglycemia risk and prevention in people with diabetes for which 10 recommendations were made. The guideline includes conditional recommendations for use of real-time continuous glucose monitoring (CGM) and algorithm-driven insulin pumps in people with type 1 diabetes (T1D), use of CGM for outpatients with type 2 diabetes at high risk for hypoglycemia, use of long-acting and rapid-acting insulin analogs, and initiation of and continuation of CGM for select inpatient populations at high risk for hypoglycemia. Strong recommendations were made for structured diabetes education programs for those at high risk for hypoglycemia, use of glucagon preparations that do not require reconstitution vs those that do for managing severe outpatient hypoglycemia for adults and children, use of real-time CGM for individuals with T1D receiving multiple daily injections, and the use of inpatient glycemic management programs leveraging electronic health record data to reduce the risk of hypoglycemia.

The recommendations are based on the consideration of critical outcomes as well as implementation factors such as feasibility and values and preferences of people with diabetes. These recommendations can be used to inform clinical practice and health care system improvement for this important complication for people living with diabetes.

Interventions targeting hypoglycemia in people with diabetes are important for improving quality of life and reducing morbidity and mortality.

To support development of the Endocrine Society Clinical Practice Guideline for management of individuals with diabetes at high risk for hypoglycemia.

We searched several databases for studies addressing 10 questions provided by a guideline panel from the Endocrine Society. Meta-analysis was conducted when feasible. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess certainty of evidence.

We included 149 studies reporting on 43 344 patients. Continuous glucose monitoring (CGM) reduced episodes of severe hypoglycemia in patients with type 1 diabetes (T1D) and reduced the proportion of patients with hypoglycemia (blood glucose [BG] levels <54 mg/dL). There were no data on use of real-time CGM with algorithm-driven insulin pumps vs multiple daily injections with BG testing in people with T1D. CGM in outpatients with type 2 diabetes taking insulin and/or sulfonylureas reduced time spent with BG levels under 70 mg/dL. Initiation of CGM in hospitalized patients at high risk for hypoglycemia reduced episodes of hypoglycemia with BG levels lower than 54 mg/dL and time spent under 54 mg/dL. The proportion of patients with hypoglycemia with BG levels lower than 70 mg/dL and lower than 54 mg/dL detected by CGM was significantly higher than point-of-care BG testing. We found no data evaluating continuation of personal CGM in the hospital. Use of an inpatient computerized glycemic management program utilizing electronic health record data was associated with fewer patients with and episodes of hypoglycemia with BG levels lower than 70 mg/dL and fewer patients with severe hypoglycemia compared with standard care. Long-acting basal insulin analogs were associated with less hypoglycemia. Rapid-acting insulin analogs were associated with reduced severe hypoglycemia, though there were more patients with mild to moderate hypoglycemia. Structured diabetes education programs reduced episodes of severe hypoglycemia and time below 54 mg/dL in outpatients taking insulin. Glucagon formulations not requiring reconstitution were associated with longer times to recovery from hypoglycemia, although the proportion of patients who recovered completely from hypoglycemia was not different between the 2 groups.

This systematic review summarized the best available evidence about several interventions addressing hypoglycemia in people with diabetes. This evidence base will facilitate development of clinical practice guidelines by the Endocrine Society.

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.

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.

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).

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.

Point-of-care testing (POCT) performed by the patient at home, paired with eHealth technologies, offers a wealth of opportunities to develop individualized, empowering clinical pathways. The non-dialysis-dependent chronic kidney disease (CKD) patient who is at risk of or may already be suffering from a number of the associated complications of CKD represents an ideal patient group for the development of such initiatives. The current coronavirus disease 2019 pandemic and drive towards shielding vulnerable individuals have further highlighted the need for home testing pathways. In this narrative review we outline the evidence supporting remote patient management and the various technologies in use in the POCT setting. We then review the devices currently available for use in the home by patients in five key areas of renal medicine: anaemia, biochemical, blood pressure (BP), anticoagulation and diabetes monitoring. Currently there are few devices and little evidence to support the use of home POCT in CKD. While home testing in BP, anticoagulation and diabetes monitoring is relatively well developed, the fields of anaemia and biochemical POCT are still in their infancy. However, patients' attitudes towards eHealth and home POCT are consistently positive and physicians also find this care highly acceptable. The regulatory and translational challenges involved in the development of new home-based care pathways are significant. Pragmatic and adaptable trials of a hybrid effectiveness-implementation design, as well as continued technological POCT device advancement, are required to deliver these innovative new pathways that our patients desire and deserve.

Recent studies have shown that the slightly elevated circulating levels of ketone bodies (KBs) played a significant role in the treatment of various diseases. This study is aimed at investigating the association between different levels of KBs and kidney function in patients with type 2 diabetes mellitus (T2DM).

A retrospective study of 955 patients with T2DM (426 women and 529 men) admitted to our hospital from December 2017 to September 2019 was conducted. Patients were divided into different groups in line with the levels of KBs (low-normal group: 0.02-0.04 mmol/L, middle-normal group: 0.05-0.08 mmol/L, high-normal group: 0.09-0.27 mmol/L, and slightly elevated group: >0.27 and <3.0 mmol/L).

In the present study, individuals with high-normal levels of KBs had the lowest risk of diabetic kidney disease (DKD) and increased peak systolic velocity (PSV); those with middle-normal levels of KBs had the lowest risk of increased renal arterial resistive index (RI), with a positive correlation between increased α1-microglobulin and KB concentration. In addition, the indicators of glomerulus, renal tubules, and renal arteries were all poor with slightly elevated circulating levels of KBs, and KB concentration lower than 0.09 mmol/L can be applied as the threshold for low risk of renal function damage.

In summary, slightly elevated circulating levels of ketone bodies are not of benefit for renal function in patients with type 2 diabetes mellitus.

Use of insulin in patients with diabetes and advanced chronic kidney disease (CKD; stages 4 to 5) is challenging and shows great variability among individuals. We explored the mechanisms underlying this variability.

PubMed was searched for articles in English from 1960 to 2018 for advanced CKD and diabetes, glucose and insulin metabolism, insulin clearance, secretion and resistance, plasma insulin concentration, glycemic control, hypoglycemia, insulin dosage, and continuous glucose monitoring (CGM) in CKD.

The evidence shows that in most patients the daily dose of insulin needs to be significantly reduced with a high degree of variability; in some the dose remains unchanged, and rarely it is increased. The premise that the marked reduction in insulin requirement is essentially attributable to decreased insulin clearance by kidneys leading to prolongation of its plasma half-life, elevated blood insulin concentration, and hypoglycemia is not entirely correct. Other factors including decreases in food intake, insulin secretion, insulin clearance by peripheral tissues, and renal gluconeogenesis play important roles. There is also heightened resistance to insulin due to metabolic acidosis, uremic toxins, inflammatory state, and vitamin D deficiency. Importantly, the magnitude of changes in each of these factors varies between individuals with the same degree of CKD.

In the presence of diabetes with advanced CKD, the insulin regimen should be individualized based on knowledge of the daily glucose patterns. The use of CGM is promising for safer glycemic control in patients with advanced CKD and diabetes and helps prevent extremes of hypoglycemia and hyperglycemia.

Attaining and maintaining good glycemic control is a cornerstone of diabetes care. The monitoring of glycemic control is currently based on the self-monitoring of blood glucose (SMBG) and laboratory testing for hemoglobin A1c (HbA1c), which is a surrogate biochemical marker of the average glycemia level over the previous 2-3 mo period. Although hyperglycemia is a key biochemical feature of diabetes, both the level of and exposure to high glucose, as well as glycemic variability, contribute to the pathogenesis of diabetic complications and follow different patterns in type 1 and type 2 diabetes. HbA1c provides a valuable, standardized and evidence-based parameter that is relevant for clinical decision making, but several biological and analytical confounders limit its accuracy in reflecting true glycemia. It has become apparent in recent years that other glycated proteins such as fructosamine, glycated albumin, and the nutritional monosaccharide 1,5-anhydroglucitol, as well as integrated measures from direct glucose testing by an SMBG/continuous glucose monitoring system, may provide valuable complementary data, particularly in circumstances when HbA1c results may be unreliable or are insufficient to assess the risk of adverse outcomes. Long-term associations of these alternative biomarkers of glycemia with the risk of complications need to be investigated in order to provide clinically relevant cut-off values and to validate their utility in diverse populations of diabetes patients.

Diabetes is the leading cause of kidney disease globally. Diabetic kidney disease (DKD) is a heterogeneous disorder manifested as albuminuria and/or decreasing GFR. Hyperglycemic burden is the major contributor to the development of DKD. In this article, we review the evidence for the contribution of glycemic variability and the pitfalls associated with use of hemoglobin A1c (A1C), the gold standard for assessment of glucose control, in the setting of DKD.

Glycemic variability, characterized by swings in blood glucose levels, can result in generation of mitochondrial reactive oxygen species, a putative inciting factor for hyperglycemia-induced alterations in intracellular metabolic pathways. While there is indirect evidence supporting the role of glycemic variability in the pathogenesis of DKD, definitive data are lacking. A1C has many limitations and is a particularly suboptimal measure in patients with kidney disease, because its accuracy is compromised by variables affecting RBC survival and other factors. Continuous glucose monitoring (CGM) technology has the potential to enable us to use glucose as a more important clinical tool, for a more definitive understanding of glucose variability and its role in DKD. Glycemic variability may be a factor in the development of DKD, but definitive evidence is lacking. Currently, all available glycemic biomarkers, including A1C, have limitations and in the setting of DKD and should be used cautiously. Emerging data suggest that personal and professional CGM will play an important role in managing diabetes in patients with DKD, where risk of hypoglycemia is high.

Diabetes mellitus (DM) is one of the leading causes of chronic kidney disease (CKD) which eventually leads to insulin resistance and decreased insulin degradation. In patients with diabetic kidney disease (DKD), the overall insulin requirement declines which necessitates the reassessment for individualization, adjustment and titration of insulin doses depending on the severity of kidney disease.

To provide simple and easily implementable guidelines to primary care physicians on appropriate insulin dosing and titration of various insulin regimens in patients with DKD.

Each insulin regimen (basal, prandial, premix and basal-bolus) was presented and evaluated for dosing and titration based on data from approved medical literatures on chronic kidney disease. These evaluations were then factored into the national context based on the expert committee representatives' and key opinion leaders' clinical experience and common therapeutic practices followed in India.

Recommendations based on dosing and titration of insulins has been developed. Moreover, the consensus group also recommended the strategy for dose estimation of insulin, optimal glycaemic targets and self-monitoring in patients with DKD.

The consensus based recommendations will be a useful reference tool for health care practitioners to initiate, optimise and intensify insulin therapy in patients with DKD.