Feasibility Of Continuous Glucose Monitoring Research Articles

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial

ObjectivesTo assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes.DesignA 2:1 open randomised...

Role of hyperglycemia in cystic fibrosis pulmonary exacerbations

BackgroundHyperglycemia could affect treatment response during cystic fibrosis (CF) exacerbations. We aimed to evaluate the prevalence and associations of hyperglycemia with exacerbation outcomes. We also evaluated feasibility of continuous glucose monitoring (CGM) during exacerbations. MethodsThe STOP2 study assessed efficacy and safety of different durations of intravenous antibiotics for CF exacerbations. We conducted a secondary data analysis of random glucose levels measured as part of clinical care during exacerbations. A small subset of participants also underwent CGM per research protocol. The associations between hyperglycemia, defined as random glucose ≥140 mg/dL, and changes in weight and lung function with exacerbation treatment were evaluated with linear regression after adjustment for confounding variables. ResultsGlucose levels were available for 182 STOP2 participants of mean (SD) age 31.6 (10.8) years, baseline percent predicted (pp) FEV1 53.6 (22.5); 37% had CF related diabetes and 27% were on insulin. Hyperglycemia was detected in 44% of participants. Adjusted mean difference (95% CI) was 1.34% (-1.39, 4.08) (p = 0.336) for change in ppFEV1 and 0.33 kg (-0.11, 0.78) (p = 0.145) for change in weight between hyperglycemic and non-hyperglycemic groups. Ten participants not on antidiabetic agents in the 4 weeks prior to enrollment underwent CGM; mean (SD) time spent >140 mg/dL was 24.6% (12.5) with 9/10 participants spending >4.5% time >140 mg/dL. ConclusionsHyperglycemia identified with random glucose is prevalent during CF exacerbations but not associated with changes in lung function or weight with exacerbation treatment. CGM is feasible and may provide a useful tool for hyperglycemia monitoring during exacerbations.

952-P: The Accuracy and Feasibility of Continuous Glucose Monitoring in COVID-19 Non-Critically Ill Hospitalized Patients—A Pilot Study

Background: Optimal glycemic control is associated with favorable outcomes in COVID-19 hospitalized patients. Frequent capillary blood glucose (CBG) monitoring is difficult to perform. Using continuous glucose monitoring (CGM) system to assist glycemic care can reduce the exposure of healthcare personnel and PPE usage. However, data on the accuracy of CGM in this setting are limited. Objective: To evaluate the accuracy and feasibility of real-time CGM (rt-CGM) in non-ICU hospitalized adult COVID-19 patients. Methods: This is a single-center prospective study of non-ICU hospitalized adult patients with COVID-19 infection who had hyperglycemia requiring insulin therapy during admission. Medtronic Guardian Connect rt-CGM sensor and transmitter were placed on the patient’s abdomen. Paired CBG and sensor glucose values were analyzed for accuracy of CGM using mean absolute relative difference (MARD) and Clarke Error Grid Analysis (CEGA). Results: Fifteen patients were enrolled. Mean age was 48.6 ± 17.9 years. Thirteen patients (86.7%) had pre-existing diabetes. Mean HbA1c was 10.6± 3.6%. Mean duration of CGM use was 6 ± 1.2 days and mean calibration was 2.6 ± 0.7 times/day. There were 253 paired CBG and CGM measurements. The overall MARD was 9.9 ± 9.3%. The lowest MARD was observed in the CBG range of 70-180 mg/dl (9.6 ± 9.0%). The percentages of glucose readings within ±15%/15 mg/dL, ±20%/20 mg/dL, and ±30%/30 mg/dL were 80.2%, 89.7%, and 95.3%, respectively. A total of 99.2% of the data points were in zone A and B of CEGA, and none were in zone E. Percent time in range on day 1 was 57.9 ± 22.9 and improved to 64.9 ± 18.1 in the last 72 hours of sensor wear. No adverse events from the CGM were observed. CGM reduced POC testing by 30%. Conclusions: Rt-CGM use in hospitalized patients with COVID-19 infection demonstrates high accuracy and potentially improves glucose control, reduces the frequency of CBG testing, and preserves medical resources. Disclosure C.Sakjirapapong: None. S.Sirinvaravong: None. L.Preechasuk: None. N.Thongtang: None. Funding Specific League Funds (R016421005)

Acceptability and feasibility of continuous glucose monitoring in people with diabetes: protocol for a mixed-methods systematic review of quantitative and qualitative evidence

Good glycaemic control is a crucial part of diabetes management. Traditional assessment methods, including HbA1c checks and self-monitoring of blood glucose, can be unreliable and inaccurate. Continuous glucose monitoring (CGM) offers a non-invasive and more detailed alternative. Availability of this technology is increasing worldwide. However, there is no current comprehensive evidence on the acceptability and feasibility of these devices. This is a protocol for a mixed-methods systematic review of qualitative and quantitative evidence about acceptability and feasibility of CGM in people with diabetes. We will search MEDLINE, Embase, CINAHL, and CENTRAL for qualitative and quantitative evidence about the feasibility and acceptability of CGM in all populations with diabetes (any type) using search terms for "continuous glucose monitoring" and "diabetes". We will not apply any study-type filters. Searches will be restricted to studies conducted in humans and those published from 2011 onwards. We will not restrict the search by language. Study selection and data extraction will be carried out by two reviewers independently using Rayyan and Eppi-Reviewer, respectively, with disagreements resolved by discussion. Data extraction will include key information about each study, as well as qualitative evidence in the form of participant quotes from primary studies and themes and subthemes based on the authors' analysis. Quantitative data relating to acceptability and feasibility including data loss, adherence, and quantitative ratings of acceptability will be extracted as means and standard deviations or n/N as appropriate. Qualitative evidence will be analysed using framework analysis informed by the Theoretical Framework of Acceptability. Where possible, quantitative evidence will be combined using random-effects meta-analysis; otherwise, a narrative synthesis will be performed. The most appropriate method for integrating qualitative and quantitative findings will be selected based on the data available. Ongoing assessment of the acceptability of interventions has been identified as crucially important to scale-up and implementation. This review will provide new knowledge with the potential to inform a programme theory of CGM as well as future roll-out to potentially vulnerable populations, including those with severe mental illness. PROSPERO CRD42021255141.

Continuous glucose monitoring assessment of metabolic control in east African children and young adults with type 1 diabetes: A pilot and feasibility study.

BackgroundFor individuals with type 1 diabetes (T1D) in East Africa and other low‐income regions, the last decade has seen substantial gains in access to insulin and trained healthcare providers, yet metabolic control remains poor.MethodsThe objective was to determine the feasibility of continuous glucose monitoring (CGM) and to gather baseline metabolic data for future power analysis in Ugandan and Kenyan youth with T1D using a Freestyle Libre Pro blinded CGM.ResultsOf 78 participants recruited, four sensors fell off and six patients did not return, leaving 68 evaluable subjects. Average age was 16 ± 5 (range 4‐26) years, 43% female. Average diabetes duration was 7 ± 5 years, insulin dose 0.9 ± 0.3 U/kg/d, and number of fingerstick glucose levels per day 2.1 ± 1.1. All were on human insulin. Point‐of‐care HbA1c was 10.9 ± 2.7% (96 ± 30 mmol/mol). Mean number of sensor days was 13 ± 3; >90% wore the sensor for ≥10 days. Mean glucose was 231 ± 86 mg/dL (12.8 ± 4.8 mmol/L). Only 30 ± 19% of time was spent in the target range (70‐180 mg/dL; 3.9‐10 mmol/L), and 7 ± 8% of time was spent in hypoglycaemia (glucose <55 mg/dL, 3.0 mmol/L). Hypoglycaemia occurred in 81% of participants, averaging five events/wk with an average duration of 140 ± 79 minutes/event.ConclusionsDespite significant diabetes care improvements, East African youth with T1D have poor metabolic control with chronic hyper‐ and hypoglycaemia, placing them at high risk for serious acute and chronic complications. This study demonstrates the feasibility of CGM use in this population and provides baseline metabolic data that will be used to inform a future intervention study.

973-P: The Feasibility of Continuous Glucose Monitoring in Youth with Type 2 Diabetes Mellitus: A Pilot Study

Background: Continuous glucose monitoring (CGM) systems are increasing in use among youth with type 1 diabetes; however, the feasibility of wearing an unblinded, real-time CGM has not been studied in youth with type 2 diabetes. The aims of this study are to evaluate the feasibility of CGM and to explore its effects on lifestyle behaviors and glycemic control among youth with type 2 diabetes. Methods: Youth ages 12-19 years (n=17) with type 2 diabetes participated in a prospective cohort intervention study with Dexcom G6 CGM. For baseline data, participants wore a blinded CGM for the 1st week and unblinded CGM for the 2nd and 6th weeks. Glycemic and metabolic measures (glucose, insulin, c-peptide, hemoglobin A1C, fructosamine, 1,5 anhydroglucitol, lipids), 24-hour food recalls, and Youth Eating Disorder Questionnaires (YEDE-Q) were collected at baseline and conclusion of study. Results: Eight participants have completed the study to date (4F/4M, mean age 15.7 years, BMI mean 32.6 kg/m2); data on metabolic measures, food recall, YEDE-Q are pending. See Table 1. Conclusion: Based on this pilot study, CGM use among youth with type 2 diabetes is feasible and acceptable. Larger studies of longer duration are needed to demonstrate whether real-time CGM can improve glycemic control and lifestyle behaviors in this population. Disclosure A. LaRoche: None. K. Utzschneider: Consultant; Self; Novo Nordisk Inc. C. Pihoker: None. Funding National Institutes of Health (DK007247)

Evaluation of glucose control when a new strategy of increased carbohydrate supply is implemented during prolonged physical exercise in type 1 diabetes.

In healthy individuals, high carbohydrate intake is recommended during prolonged exercise for maximum performance. In type 1 diabetes (T1D), this would alter the insulin requirements. The aim of the study was to evaluate the safety of high glucose supplementation during prolonged exercise and the glucose control when a novel strategy of increased carbohydrate supply was implemented during prolonged exercise in T1D. Eight subjects with T1D participated in a sports camp including sessions of prolonged exercise and individualized feedback during three consecutive days. This was later followed by a 90 km cross-country skiing race. Large amounts of carbohydrates, 75 g/h, were supplied during exercise and the insulin requirements were registered. Glucose was measured before, during and after exercise aiming at euglycaemia, 4-8 mmol/L (72-144 mg/dL). During the race, continuous glucose monitoring (CGM) was used as an aspect of safety and to allow direct and individual adjustments. Compared to ordinary carbohydrate supply during exercise, the high carbohydrate supplementation resulted in significantly increased insulin doses to maintain euglycaemia. During the cross-country skiing race, the participants succeeded to reach mean target glucose levels; 6.5 ± 1.9 mmol/L (117 ± 34 mg/dL) and 5.7 ± 1.5 mmol/L (103 ± 27 mg/dL) at the start and finish of the race, respectively. Episodes of documented hypoglycemia (<4 mmol/L/72 mg/dL) were rare. CGM was used for adjustments. In this study, large carbohydrate supplementation in T1D individuals during prolonged aerobic exercise is safe and allows the subjects to maintain glycaemic control and indicates the feasibility of CGM under these conditions.

Feasibility of prolonged continuous glucose monitoring in toddlers with type 1 diabetes

To examine the feasibility of continuous glucose monitoring (CGM) use in very young children with type 1 diabetes (T1D). Twenty-three children less than 4 yr of age with T1D were provided with a FreeStyle Navigator(®) (n = 21) or a Paradigm(®) (n = 2) CGM device. At baseline, mean age was 3.0 ± 0.8 yr, mean hemoglobin A1c (HbA1c) was 8.0 ± 0.8%, 10 were using an insulin pump and 13 were on multiple daily injections. CGM use was evaluated over a 6-month period. Three children dropped out of the study before the end of 6 months. Among the 20 children who completed 6 months of follow-up, CGM use in month 6 was ≥6 d/wk in 9 (45%), 4 ≤ 6 d/wk in 2 (10%), and <4 d/wk in 9 (45%). Skin reactions were minimal. Although there was no detectable change in mean HbA1c between baseline and 6 months (7.9 and 8.0%, respectively), there was a high degree of parental satisfaction with CGM as measured on the CGM satisfaction scale questionnaire. A high percentage of glucose values were in the hyperglycemic range, and biochemical hypoglycemia was infrequent. More than 40% of very young children were able to safely use CGM on a near-daily basis after 6 months. CGM demonstrated frequent hyperglycemic excursions, with a large variability in glucose readings. Although improvement in glycemic control was not detected in the group as a whole, parental satisfaction with CGM was high.

Feasibility of Continuous Glucose Monitoring in Critically Ill Emergency Department Patients

BackgroundGlucose control is important in the management of critically ill patients. However, strict glucose control requires a large amount of nursing resources, especially in overcrowded emergency departments (EDs). ObjectivesA continuous glucose monitoring system (CGMS) may be beneficial for glucose control in the ED. The objective of this study was to determine the test characteristics of CGMS in critically ill ED patients. MethodsA prospective observational study of critically ill ED patients was conducted. During a patient’s visit to the ED, a CGMS sensor measured their interstitial fluid glucose levels continuously. Capillary glucose was measured every hour and used for glucose control and as a reference value. CGMS values were recorded in real time and compared with capillary glucose values. ResultsA total of 122 pairs of capillary and CGMS glucose values in 12 patients were analyzed. The correlation coefficient was 0.87, and Bland-Altman analysis showed that 117 pairs (95.9%) were within a 95% confidence interval. A Clarke Error Grid Analysis indicated an overall accuracy of 96.8% (Zones A and B). However, the mean absolute relative difference (MARD) was significantly higher in the hypoglycemic range than in a normo- or hyperglycemic range (p = 0.001). The sensitivity and positive predictive value of CGMS for detecting hypoglycemia were 33.3% and 16.7%, respectively. The CGMS specificity and negative predictive value were 95.8% and 98.3%, respectively. There was no linear correlation between MARD and body mass index, axillary temperature, inotrope score, and base deficit (all p-value >0.05). ConclusionCGMS demonstrated good clinical accuracy by Clarke Error Grid Analysis. There also was high agreement between CGMS and capillary glucose levels. However, CGMS demonstrated only limited real-time hypoglycemia detection ability in critically ill ED patients.

Continuous glucose monitoring‐enabled insulin‐pump therapy in diabetic pregnancy

We describe the feasibility of continuous glucose monitoring (CGM)-enabled insulin-pump therapy during pregnancy in a woman with type 1 diabetes, who was treated with CGM-enabled insulin-pump therapy in her third pregnancy. During her first pregnancy, the woman was treated with multiple daily injections and baseline HbA1c was 8.9%. Due to pre-eclampsia, the child was born preterm, and had neonatal hypoglycemia. In the planning of the second pregnancy, insulin-pump therapy was initiated, resulting in an HbA1c of 6.8% in early pregnancy. Due to pre-eclampsia, the second child was born preterm, but without neonatal morbidity. Before her third pregnancy, CGM-enabled insulin-pump therapy was introduced, and HbA1c was 6.4% in early pregnancy. The patient was satisfied with this therapy, pre-eclampsia did not occur, and the child was born at term without neonatal morbidity. CGM-enabled insulin-pump therapy appears feasible in diabetic pregnancies.

261: Feasibility of continuous glucose monitoring in labor

261: Feasibility of continuous glucose monitoring in labor

The continuous glucose monitoring sensor in neonatal intensive care

Objective: To determine the feasibility of continuous glucose monitoring in the very low birthweight baby requiring intensive care, as these infants are known to be at high risk of abnormalities...

Subcutaneous Continuous Glucose Monitoring

Devices for continuous glucose monitoring (1,2) should display the data in real time rather than retrospectively. This is possible by means of the microdialysis technique (3). Therefore, we examined the feasibility of continuous glucose monitoring with functional models of a new microdialysis-based subcutaneous continuous glucose monitoring (SCGM) system (Roche Diagnostics, Mannheim, Germany) for up to 72 h. This system was calibrated by a one-point calibration shortly after the beginning of the recording period. The SCGM system consists of a microdialysis catheter and a portable extracorporal electrochemical glucose sensor. It displays a new glucose value every minute. The system was tested in 23 ambulatory inpatients with insulin-treated type 1 and type 2 diabetes. For comparison, up to 75 capillary blood glucose samples were taken in each patient. …