Continuous glucose monitoring for treatment adjustment in diabetic pregnancies--a pilot study.

AIMS: To examine the efficacy of a continuous glucose monitoring (CGM) system for treatment adjustment in patients with diabetic pregnancy treated with insulin. METHODS: The study sample consisted of eight women with diabetic pregnancy, six with pre-pregnancy Type 1 diabetes mellitus and two with gestational diabetes (GDM), all being treated with multiple daily insulin injections. Gestational age ranged from 24 to 32 weeks. Data derived from the Continuous Glucose Monitoring System (MiniMed) for 72 h were compared with fingerstick glucose measurements (six to eight times a day), and treatment was adjusted on the basis of the findings. Two to four weeks later, the patients were re-evaluated with CGM. RESULTS: In the first part of the study, an average of 744+/-33 glucose measurements was recorded for each patient with CGM. The mean total time of hyperglycaemia (glucose level >7.7 mmol/l) undetected by the fingerstick method was 152+/-33 min/day. Nocturnal hypoglycaemic events (glucose level <2.7 mmol/l) were recorded in seven patients. Based on the additional information obtained by continuous monitoring, the insulin regimen was changed in all patients. CGM re-evaluation after treatment adjustment showed a reduction in undetected hyperglycaemia to 89+/-17 min/day and in nocturnal hypoglycaemic events, which were recorded in only one patient. CONCLUSIONS: Continuous glucose monitoring may diagnose high blood glucose levels and nocturnal hypoglycaemic events that are unrecognized by intermittent blood glucose monitoring and could serve as a useful tool for the long-term management of diabetic pregnancies. A large prospective study is needed to determine the clinical implications of this new monitoring technique.     

Continuous glucose monitoring in managing diabetes in children

Continuous glucose monitoring (CGM) devices have now been added to the repertoire of technological devices useful in the management of patients with diabetes. In this issue, Schiaffini and colleagues confirm and extend published data describing the benefits of CGM in diabetic children. Specifically, such monitoring enables clinicians to detect occult hypoglycemia not otherwise discernable with intermittent testing of blood glucose. Although results of monitoring are not yet available in real time, the data can be used to adjust insulin regimens to allow more effective glycemic control. This is especially important in the pediatric population for whom strict glycemic control has traditionally been limited owing to concerns about the negative effects of hypoglycemia on the developing central nervous system. Additionally, postprandial hyperglycemia can be more readily detected and controlled. CGM provides new and important information not necessarily provided by measurement of HbA1c, and will likely prove an indispensable adjunct to diabetes care. Finally, this procedure has potential applications in the diagnosis and management of patients with other metabolic disorders.     

Continuous glucose monitoring: a review of the evidence,opportunities for future use and ongoing challenges

The advent of devices that can track interstitial glucose levels, which are closely related to blood glucose levels, on a near continuous basis, has facilitated better insights into patterns of glycaemia. Continuous glucose monitoring (CGM) therefore allows for more intensive monitoring of blood glucose levels and potentially improved glycaemic control. In the context of the announcement on 1 April 2017 that the Australian Government will fund CGM monitoring for people with type 1 diabetes under the age of 21 years, this paper provides a review of the evidence for CGM and some of the ongoing challenges. There is evidence that real‐time CGM in type 1 diabetes improves HbA1c and hypoglycaemia, while in type 2 diabetes, the evidence is less robust. Initial barriers to widespread implementation of CGM included issues with accuracy and user friendliness; however, as the technology has evolved, these issues have largely improved. Ongoing barriers include cost, and weaker evidence for their benefit in certain populations such as those with type 2 diabetes and less glycaemic variability. CGM has the potential to reduce healthcare costs, although real‐world studies, including cost‐effectiveness analyses, are needed in this area.     

Diabetes in pregnancy outcomes: A systematic review and proposed codification of definitions

Rising rates of diabetes in pregnancy have led to an escalation in research in this area. As in any area of clinical research, definitions of outcomes vary from study to study, making it difficult to compare research findings and draw conclusions. Our aim was to compile and create a repository of definitions, which could then be used universally. A systematic review of the literature was performed on published and ongoing randomized controlled trials in the area of diabetes in pregnancy between 01 Jan 2000 and 01 Jun 2012. Other sources included the World Health Organization and Academic Society Statements. The advice of experts was sought when appropriate definitions were lacking. Among the published randomized controlled trials on diabetes and pregnancy, 171 abstracts were retrieved, 64 full texts were reviewed and 53 were included. Among the ongoing randomized controlled trials published in ClinicalTrials.gov, 90 protocols were retrieved and 25 were finally included. The definitions from these were assembled and the final maternal definitions and foetal definitions were agreed upon by consensus. It is our hope that the definitions we have provided (i) will be widely used in the reporting of future studies in the area of diabetes in pregnancy, that they will (ii) facilitate future systematic reviews and formal meta analyses and (iii) ultimately improve outcomes for mothers and babies. Copyright © 2015 John Wiley & Sons, Ltd.     

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.     

Benefits of blinded continuous glucose monitoring during a randomized clinical trial

Background:

Real-time, personal continuous glucose monitoring (CGM) is a validated technology that can help patients improve glycemic control. Blinded CGM is a promising technology for obtaining retrospective data in clinical research where the quantity and quality of blood glucose information is important. This study was designed to investigate the use of novel procedures to enhance data capture from blinded CGM.

Methods:

Following a 4-week run-in, 46 patients with type 1 diabetes were randomized to one of two prandial insulins for a 12-week treatment period, after which they were crossed over to the alternate treatment for 12 weeks. Continuous glucose monitoring was implemented at the end of run-in (practice only) and during the last 2 weeks of each treatment period. Eighty percent of 288 possible daily glucose values were required for at least three days. Continuous glucose monitoring was extended for an additional week if these criteria were not met, and patients were allowed to insert sensors at home when necessary. Continuous glucose monitoring results were compared to reference eight-point self-monitoring of blood glucose (SMBG).

Results:

Higher than expected sensor failure rate was approximately 25%. During run-in, 12 of 45 attempted profiles failed adequacy criteria. However, treatment periods had only 1 of 82 attempted profiles considered inadequate (6 cases required an additional week of CGM). Using SMBG as reference, 93.7% of 777 CGM values were in Clarke error grid zones A+B.

Conclusions:

With appropriate training, adequate practice, and opportunity to repeat blinded CGM as needed, nearly 100% of attempted profiles can be obtained successfully.