Abstract: BACKGROUND: Intensive selfmonitoring is an important and cost-demanding part of diabetes treatment. Continuous glucose monitoring (CGM) using transcutaneous sensors offers "real time" information on glycemia. In the present study, we assessed the therapeutic efficacy of CGM on metabolic control using two different statistical methods: linear regression and "survival analysis". OBJECTIVES: (1) to assess the therapeutic efficacy of CGM on metabolic control using two different statistical methods: linear regression and survival analysis; (2) to demonstrate the particular advantages of each statistical method. METHODS: A total of 42 persons with diabetes mellitus treated by means of an insulin pump participated in this study. According to the means of selfmonitoring persons with diabetes were divided into two groups: 1. intervention group of 17 persons using CGM, 2. control group of 25 persons using a glucometer. Each person was followed for a period of three months. At the beginning of the study and at the end of each month HbA1c was determined. RESULTS: Both the regression analysis and survival analysis brought evidence of significant changes of the HbA1c in either of the groups. The method of linear regression enables to analyse the evolution of HbA1c in each individual person followed by comparison of the groups. The survival analysis demonstrated that the probability of HbA1c decrease to the predefined level as well as its further maintaining at this level was higher in the CGM group. The mean time interval necessary to HbA1c decrease was shorter in the CGM group. CONCLUSIONS: The efficacy of CGM was demonstrated. In addition to linear regression, survival analysis appears to be an useful complementary method in the statistical evaluation of the treatment efficacy.
Abstract: Background: Intensive selfmonitoring is an important and cost-demanding part of diabetes treatment. Continuous glucose monitoring (CGM) using transcutaneous sensors offers "real time" information on glycemia. In the present study, we assessed the therapeutic efficacy of CGM on metabolic control using two different statistical methods: linear regression and "survival analysis". Objectives: (1) to assess the therapeutic efficacy of CGM on metabolic control using two different statistical methods: linear regression and survival analysis; (2) to demonstrate the particular advantages of each statistical method. Methods: A total of 42 persons with diabetes mellitus treated by means of an insulin pump participated in this study. According to the means of selfmonitoring persons with diabetes were divided into two groups: 1. intervention group of 17 persons using CGM, 2. control group of 25 persons using a glucometer. Each person was followed for a period of three months. At the beginning of the study and at the end of each month HbA1c was determined. Results: Both the regression analysis and survival analysis brought evidence of significant changes of the HbA1c in either of the groups. The method of linear regression enables to analyse the evolution of HbA1c in each individual person followed by comparison of the groups. The survival analysis demonstrated that the probability of HbA1c decrease to the predefined level as well as its further maintaining at this level was higher in the CGM group. The mean time interval necessary to HbA1c decrease was shorter in the CGM group. Conclusions: The efficacy of CGM was demonstrated. In addition to linear regression, survival analysis appears to be an useful complementary method in the statistical evaluation of the treatment efficacy.
Abstract: Year: 2008
Abstract Number: 1978-PO
Authors: RUDOLF CHLUP, HELENA PÅIBYLOVÃ, KAROLINA PETERSON, KATEÅINA LANGOVÃ, VERONIKA MATUÅ KOVÃ, PAVLA KUDLOVÃ, SVATAVA TÃNCOSOVÃ, JIÅà LUŽA, Olomouc, Czech Republic, Moravský Beroun, Czech Republic
Institutions: Moravský Beroun, Czech Republic; Olomouc, Czech Republic
Results: Continuous Glucose Monitoring is becoming a useful tool for diabetes control. However, exact data about patient´s interest in transcutaneous sensors are missing. The aim of this prospective study was to asses the demands for long-lasting use of sensors in persons with diabetes (PWD) on insulin pumps. Forty PWD aged 19 to 83 years, duration of diabetes 1 to 44 years, using insulin pump Paradigm X22 were given a concise 30-min lecture on CGM and offered transcutaneous sensors for a 3-month period free of charge. The education of PWD was performed individually or in small groups by an experienced educator. Several months later the same offer was repeated. The diabetes control at start and end of the study was compared.
Twenty two of 40 PWD (55%) accepted the suggestion and entered the 3-month sensor study. The reasons for a primary sensor refusal (n=18, 45%) were insufficient educational capacity of the center (n=9), lack of time due to occupation (n=5) or family (n=2) and blindness (n=1), nevertheless, 13 of them (33% of 40) would be interested in a short use of sensor (up to one week) without being involved in the study. In the course of 3 study-weeks, 5 persons (12%) interrupted CGM due to technical problems with the transmitter (n=1) or due to personal reasons (n=4); To date, 17 PWD (43%) are using the sensor continuously, all of them are showing interest in long-lasting use in the future.
Hence, the sensors (free of charge) are demanded for long-lasting use by about 43% of PWDs on insulin pumps Paradigm X22. The main reason for the CGM denial was the insufficient educational capacity of the diabetes center.
Category: Clinical Therapeutics/New Technology - Glucose Monitoring and Sensing
Abstract: Aims: There is no standardized protocol for measuring glycemic index (GI) that takes time-of-day effects into account. The software DegifXL2 and Medtronic-Minimed's CGMS (TM) and Solutions (TM), makes the GI calculation at breakfast and dinner time possible. The aim of this study was to assess the enhanced data processing software (DegifXL4) enabling the GI calculation at breakfast, lunch, afternoon snack and dinner times. Methods: The glucose levels of 20 healthy volunteers were monitored after they consumed either 50 g of glucose or one of ten alternative foodstuffs either for breakfast and dinner or for lunch or snack. Within the 9-day test period, 10 such meals were monitored in 3 replicates for each volunteer. Specifically, CGMS (TM) was used to monitor plasma glucose levels at 5-minute intervals for a period of 120 min following the foodstuff. ingestion. Results: Using the enhanced spreadsheed DegifXL 4, a total of 640 profiles were obtained and 491 (77 %) accomplished the criteria for further processing. The percentage of successful tests in each foodstuff. varied from 57 to 87 %. Conclusions: The use of the new software DegifXL4 offers accurate GI estimates for foodstuffs eaten for breakfast, lunch, snacks and dinners in three replicates. In combination with the CGMS Solutions Software (TM) is DegifXL4 an enhanced efficient and comfortable way to routinely measure GI values.
Abstract: AIMS: There is no standardized protocol for measuring glycemic index (GI) that takes time-of-day effects into account. The software DegifXL2 and Medtronic-Minimed's CGMS and Solutions, makes the GI calculation at breakfast and dinner time possible. The aim of this study was to assess the enhanced data processing software (DegifXL4) enabling the GI calculation at breakfast, lunch, afternoon snack and dinner times. METHODS: The glucose levels of 20 healthy volunteers were monitored after they consumed either 50 g of glucose or one of ten alternative foodstuffs either for breakfast and dinner or for lunch or snack. Within the 9-day test period, 10 such meals were monitored in 3 replicates for each volunteer. Specifically, CGMS was used to monitor plasma glucose levels at 5-minute intervals for a period of 120 min following the foodstuff ingestion. RESULTS: Using the enhanced spreadsheed DegifXL 4, a total of 640 profiles were obtained and 491 (77 %) accomplished the criteria for further processing. The percentage of successful tests in each foodstuff varied from 57 to 87 %. CONCLUSIONS: The use of the new software DegifXL4 offers accurate GI estimates for foodstuffs eaten for breakfast, lunch, snacks and dinners in three replicates. In combination with the CGMS Solutions Software is DegifXL4 an enhanced efficient and comfortable way to routinely measure GI values.
