Continuous Glucose Monitoring Use in Clinical Trials for On-Market Diabetes Drugs

To the best of our knowledge, there are no published data on the historical and recent use of CGM in clinical trials of pharmacological agents used in the treatment of diabetes. We analyzed 2,032 clinical trials of 40 antihyperglycemic therapies currently on the market with a study start date between 1 January 2000 and 31 December 2019. According to ClinicalTrials.gov, 119 (5.9%) of these trials used CGM. CGM usage in clinical trials has increased over time, rising from <5% before 2005 to 12.5% in 2019. However, it is still low given its inclusion in the American Diabetes Association’s latest guidelines and known limitations of A1C for assessing ongoing diabetes care.

The availability of reliable continuous glucose monitoring (CGM) systems has proven to be a major innovation in diabetes management and research. Most current CGM systems are approved for 7- to 14-day use and use a wire-tipped glucose oxidase sensor inserted in subcutaneous tissue to monitor glucose concentrations in interstitial fluid. One implanted CGM system is approved for longer-term use (90–180 days); it operates with fluorescence-based technology. CGM sensors record a glucose data point every 1–15 minutes (depending on the system), collecting far more granular data and information on glycemic patterns than self-monitoring of blood glucose (SMBG) alone. Real-time CGM or intermittently scanned CGM systems send data continuously or intermittently to dedicated receivers or smartphones, whereas professional CGM systems provide retrospective data, either blinded or unblinded, for analysis and can be used to identify patterns of hypo- and hyperglycemia. Professional CGM can be helpful to evaluate patients when other CGM systems are not available to the patient or the patient prefers a blinded analysis or a shorter experience with unblinded data.In the 20 years since CGM systems first became available to people with diabetes, technological improvements, particularly pertaining to accuracy and form factor, have made CGM increasingly viable for both patient use and clinical investigation (1,2). Average sensor MARD (mean absolute relative difference; a summary accuracy statistic) has decreased from >20 to <10% (3–10), including two systems that do not require fingerstick calibrations and three that are approved to be used for insulin dosing (11). Concurrently, size, weight, and cost of CGM systems have all decreased, while user-friendliness and convenience have increased (12).To encourage use of CGM-derived data, researchers and clinicians have worked to develop a standard set of glycemic metrics beyond A1C. In 2017, two international groups of leading diabetes clinical and research organizations published consensus definitions for key metrics, including clinically relevant glycemic cut points for hypoglycemia (<70 and <54 mg/dL), hyperglycemia (>180 and >250 mg/dL), and time in range (TIR; 70–180 mg/dL) (13,14).CGM-derived metrics provide far greater precision and granularity than is possible with SMBG or A1C data alone (Table 1), enabling clinicians and investigators to better represent inter- and intraday glycemic differences with metrics such as TIR, glycemic variability, and time in hypoglycemia and hyperglycemia (15). Crucially, CGM also allows for the accurate measurement and detection of nocturnal glycemia (16). The use of these metrics enables a more comprehensive understanding of glycemic management that can facilitate individualized treatment for people with diabetes or prediabetes. Although A1C is a useful estimate of mean glucose over the previous 2–3 months, especially when evaluating population health, it is important to include other glycemic outcomes in clinical trials. Furthermore, there is emerging evidence suggesting that TIR predicts the development of microvascular complications at least as well as A1C (17,18).TABLE 1Benefits of CGM Compared With A1C Alone in Assessing Glycemia

Acute epiploic appendagitis mimicking symptoms of urinary tract infection: A diagnostic enigma in the emergency department

The epiploic appendages (also known as appendices epiploicae) are usually located on the anti‐mesenteric surface of the colon, extending from the caecum to the rectosigmoid, and epiploic appendagitis (EA) is the inflammation of these appendages. We report a clinical image of epiploic appendagitis creating a diagnostic challenge.     

Liver regeneration after major hepatectomy. Evaluation of dogs hepatectomy

OBJECTIVES: The aim of our study is to evaluate anatomic regeneration and metabolic derangement of the liver after major resection in dogs. METHODS: This is an experimental study on 9 dogs; we divided the dogs in two groups: the first group (5 dogs) underwent at one go major hepatectomy (90% of the liver).The second group (4 dogs) underwent successively a resection of 75% of the liver and a second resection of 90% of the restored liver six months later. All dogs underwent a metabolic and morphologic studies of the liver and of their kidney function. RESULTS: In the first group; all dogs which underwent 90% hepatic resection died 48 hours after the surgical resection of hepatic insufficiency. The ultra microscopic study showed the role of portal hypertension in hepatic degeneration on the first group. In the second group, the dogs survived the first resection, and our study shows a regeneration of the liver after resection and sub normal hepatic function. CONCLUSION: The liver is able to regenerate after minimally resection but major resection must be done by successively resection to avoid hepatic dysfunction, but the time between resection must be evaluate later.     

Decision-Making for the Management of Cystic Lesions of the Pancreas: How Satisfied Are Patients with Surgery?

Introduction

This study aims to understand patients’ perspectives and satisfaction with choosing surgery for the treatment of pancreatic cystic lesions (PCLs).

Methods

A 62-question survey was administered to 113 patients who had a resection for a PCL by 12 surgeons at two pancreatic specialty centers (2004–2016). Patients’ final diagnoses and perioperative outcomes were correlated to the survey’s results using univariate analysis.

Results

Fear of cancer was quite or extremely important in most respondents’ decision to have surgery (95.4%). Respondents were quite or fully satisfied with the outcomes of surgery (91.1%) and with the decision-making process (89.3%). Distress from anxiety about the cyst before surgery (58.6%) largely outweighed that from postsurgical lifestyle changes (14.4%). Furthermore, 88.7% of patients with pathologically non-malignant disease were quite or fully satisfied with their decision to have surgery, and patients with mucinous neoplasms reported high satisfaction rates independent of grade of dysplasia or malignancy (p = 0.641).

Conclusion

Patients with a resected PCL are highly satisfied with their decision to have surgery, regardless of the final diagnosis or clinical outcome. Fear of cancer is the main driver in the decision-making process, and the anxiety of harboring a cyst is a greater cause of distress than are postsurgical lifestyle changes.