Accuracy of Tubal Patency Assessment in Diagnostic Hysteroscopy Compared with Laparoscopy in Infertile Women: A Retrospective Cohort Study.

STUDY OBJECTIVE: To evaluate whether the presence of a visualizable "flow" effect in the fallopian tube ostia in hysteroscopic routine evaluation is predictive of tube patency. DESIGN: A retrospective cohort study (Canadian Task Force Classification II-2). SETTING: Data from all patients who underwent surgery because of infertility at the study center between 2008 and 2016 were analyzed retrospectively. The main outcome parameter was fallopian tube patency as assessed by laparoscopic chromopertubation. The predictive parameters tested were the presence of hysteroscopic tube "flow," general patient characteristics, and intraoperative findings. PATIENTS: Five hundred eleven infertile women who underwent combined hysteroscopy and laparoscopy were included. INTERVENTIONS: All women underwent combined hysteroscopy and laparoscopy. Some had other interventions when necessary, but no additional interventions were taken because of this study. RESULTS: In an analysis of 998 fallopian tubes, the hysteroscopic assessment of fallopian tube "flow" was highly accurate in predicting fallopian tube patency (p < .001), with a sensitivity of 86.4% (95% confidence interval [CI], 83.7-88.8) and a specificity of 77.6% (95% CI, 72.1-82.5). Risk factors for a false-negative hysteroscopy result were the presence of uterine myomas (odds ratio [OR] = 2.11; 95% CI, 1.10-4.05; p = .025), the presence of a hydrosalpinx on the analyzed side (OR = 2.50, 95% CI, 1.17-5.34; p = .019), and the presence of peritubal adhesions surrounding the analyzed tube (OR = 2.87; 95% CI, 1.21-6.76; p = .016). CONCLUSION: A visualizable tube "flow" in hysteroscopy was accurate in the prediction of tubal patency, with a positive predictive value of about 91%. Knowledge about hysteroscopic fallopian tube "flow" can help to plan the future approach in an individual patient.

Evaluation of the performance of a novel system for continuous glucose monitoring.

BACKGROUND: The performance of a continuous glucose monitoring (CGM) system in the early stage of development was assessed in an inpatient setting that simulates daily life conditions of people with diabetes. Performance was evaluated at low glycemic, euglycemic, and high glycemic ranges as well as during phases with rapid glucose excursions. METHODS: Each of the 30 participants with type 1 diabetes (15 female, age 47 ± 12 years, hemoglobin A1c 7.7% ± 1.3%) wore two sensors of the prototype system in parallel for 7 days. Capillary blood samples were measured at least 16 times per day (at least 15 times per daytime and at least once per night). On two subsequent study days, glucose excursions were induced. For performance evaluation, the mean absolute relative difference (MARD) between CGM readings and paired capillary blood glucose readings and precision absolute relative difference (PARD), i.e., differences between paired CGM readings were calculated. RESULTS: Overall aggregated MARD was 9.2% and overall aggregated PARD was 7.5%. During induced glucose excursions, MARD was 10.9% and PARD was 7.8%. Lowest MARD (8.5%) and lowest PARD (6.4%) were observed in the high glycemic range (euglycemic range, MARD 9.1% and PARD 7.4%; low glycemic range, MARD 12.3% and PARD 12.4%). CONCLUSIONS: The performance of this prototype CGM system was, particularly in the hypoglycemic range and during phases with rapid glucose fluctuations, better than performance data reported for other commercially available systems. In addition, performance of this prototype sensor was noticeably constant over the whole study period. This prototype system is not yet approved, and performance of this CGM system needs to be further assessed in clinical studies.

Performance evaluations of continuous glucose monitoring systems: precision absolute relative deviation is part of the assessment.

BACKGROUND: Even though a Clinical and Laboratory Standards Institute proposal exists on the design of studies and performance criteria for continuous glucose monitoring (CGM) systems, it has not yet led to a consistent evaluation of different systems, as no consensus has been reached on the reference method to evaluate them or on acceptance levels. As a consequence, performance assessment of CGM systems tends to be inconclusive, and a comparison of the outcome of different studies is difficult. MATERIALS AND METHODS: Published information and available data (as presented in this issue of Journal of Diabetes Science and Technology by Freckmann and coauthors) are used to assess the suitability of several frequently used methods [International Organization for Standardization, continuous glucose error grid analysis, mean absolute relative deviation (MARD), precision absolute relative deviation (PARD)] when assessing performance of CGM systems in terms of accuracy and precision. RESULTS: The combined use of MARD and PARD seems to allow for better characterization of sensor performance. The use of different quantities for calibration and evaluation, e.g., capillary blood using a blood glucose (BG) meter versus venous blood using a laboratory measurement, introduces an additional error source. Using BG values measured in more or less large intervals as the only reference leads to a significant loss of information in comparison with the continuous sensor signal and possibly to an erroneous estimation of sensor performance during swings. Both can be improved using data from two identical CGM sensors worn by the same patient in parallel. CONCLUSIONS: Evaluation of CGM performance studies should follow an identical study design, including sufficient swings in glycemia. At least a part of the study participants should wear two identical CGM sensors in parallel. All data available should be used for evaluation, both by MARD and PARD, a good PARD value being a precondition to trust a good MARD value. Results should be analyzed and presented separately for clinically different categories, e.g., hypoglycemia, exercise, or night and day.

TheClinical Research Tool: a high-performance microdialysis-based system for reliably measuring interstitial fluid glucose concentration.

BACKGROUND: A novel microdialysis-based continuous glucose monitoring system, the so-called Clinical Research Tool (CRT), is presented. The CRT was designed exclusively for investigational use to offer high analytical accuracy and reliability. The CRT was built to avoid signal artifacts due to catheter clogging, flow obstruction by air bubbles, and flow variation caused by inconstant pumping. For differentiation between physiological events and system artifacts, the sensor current, counter electrode and polarization voltage, battery voltage, sensor temperature, and flow rate are recorded at a rate of 1 Hz. METHOD: In vitro characterization with buffered glucose solutions (c(glucose) = 0 - 26 x 10(-3) mol liter(-1)) over 120 h yielded a mean absolute relative error (MARE) of 2.9 +/- 0.9% and a recorded mean flow rate of 330 +/- 48 nl/min with periodic flow rate variation amounting to 24 +/- 7%. The first 120 h in vivo testing was conducted with five type 1 diabetes subjects wearing two systems each. A mean flow rate of 350 +/- 59 nl/min and a periodic variation of 22 +/- 6% were recorded. RESULTS: Utilizing 3 blood glucose measurements per day and a physical lag time of 1980 s, retrospective calibration of the 10 in vivo experiments yielded a MARE value of 12.4 +/- 5.7. Clarke error grid analysis resulted in 81.0%, 16.6%, 0.8%, 1.6%, and 0% in regions A, B, C, D, and E, respectively. CONCLUSION: The CRT demonstrates exceptional reliability of system operation and very good measurement performance. The ability to differentiate between artifacts and physiological effects suggests the use of the CRT as a reference tool in clinical investigations.

The SCGM1 System: subcutaneous continuous glucose monitoring based on microdialysis technique.

The SCGM1 System is designed to allow continuous glucose monitoring in the subcutaneous interstitial fluid for up to 120 h. The system is based on the microdialysis technique and is composed of three components: (1) a disposable Cassette, which contains the microdialysis catheter (with the necessary tubes), an electrochemical flow-through sensor for glucose measurement, and the fluid reservoirs for both the microdialysis perfusate and a reagent solution containing glucose oxidase; (2) the Sensor Unit, which houses the Cassette and is worn by the patient using a belt pack; and (3) the Data Manager, with an integrated blood glucose meter for the calibration of the glucose signal. The Data Manager also has the option of displaying the continuous glucose signal. The Sensor Unit and Data Manager exchange glucose data and calibration data by radio transmission. In vitro precision was assessed by measurements of two standard glucose solutions (90 mg/dL, 3.4%; 360 mg/dL, 2.4%) over a time course of 4 days. The mean difference (+/- SD) between SCGM1 System devices (n = 11) and 15 glucose standard solutions with different concentrations was 1.4 +/- 3.5 mg/dL. The mean relative difference and the mean absolute relative difference ranged from - 0.6% to 3.7% and from 0.2% to 3.8%, respectively. The inherent physical lag time was 31 +/- 2 min (n = 10). The interference on the glucose signal of ascorbic acid, acetaminophen, and uric acid at the highest physiological concentrations was below 4%. The SCGM1 System showed a reliable and precise performance under in vitro conditions.

Continuous glucose monitoring: reliable measurements for up to 4 days with the SCGM1 system.

Continuous glucose monitoring allows patients with diabetes to check their metabolic status throughout the day, including rarely monitored time periods, such as postprandial and nocturnal periods. The performance of a prototype of the novel SCGM1 System (Roche Diagnostics GmbH, Mannheim, Germany) employing the microdialysis technique was evaluated. Forty-two patients with type 1 diabetes participated in the study [29 males/13 females, age 34 +/- 9 years, duration of diabetes 16 +/- 11 years, glycated hemoglobin 7.7 +/- 1.2% (mean +/- SD)]. Forty-seven experiments were performed at four different investigational sites. A microdialysis catheter was inserted into the subcutaneous tissue of the patient's abdominal wall. Glucose was extracted from the interstitial fluid, and glucose levels were determined and stored by the SCGM1 System continuously for the duration of the experiment. Capillary blood glucose was measured frequently (at least 10 times per day) and used for linear retrospective calibration. The patients were instructed to maintain their normal diet and insulin therapy. Thirty experiments (mean duration 103 +/- 18 h) were analyzed in detail. The mean deviation of the calibrated glucose sensor values from the capillary blood glucose values (expressed as percent predicted error sum of squares) was <12.5% in 25 and <20% for all of the 30 experiments analyzed. The percent median absolute difference between the calibrated values and the reference values was <10% in 28 experiments, with a median of 5.8% for all 30 experiments. The error grid analysis of all 30 experiments showed that 99.5% of all 1,195 pairs' values were in zones A and B with only 0.2% in zone C and 0.3% in zone D. Thus the microdialysis technique employed by the SCGM1 System allows precise and accurate continuous glucose monitoring over prolonged periods of time. It appears also that effective monitoring of acute metabolic deteriorations is possible.