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Study record managers: refer to the Data Element Definitions if submitting registration or results information. Symptoms might include but were not limited to sweating, dizziness, lightheadedness, tremors, nervousness, hunger, headaches, and weakness or tiredness. The device provides glucose measurements every 5 minutes for up to 7 days.
The system contains a sensor, transmitter, and receiver. The sensor is a flexible round wire that goes under the skin to read glucose levels. The transmitter snaps into the sensor and wirelessly sends glucose readings to the receiver. Data was obtained from approximately one-third of participants and was used to calculate MAGE. Data were collected in the 3 days prior to Baseline and the Week 24 visit. The standard deviation of the blood glucose measurements in each 3-day period was calculated.
For each glucose measurement, the difference from the previous reading was calculated. Absolute differences smaller than the standard deviation were discarded. MAGE is the mean of the remaining difference scores. A bolus opportunity occurs, for example, just before eating a meal. The mean meal error MME , an indicator of accuracy, and mean meal absolute error MMAE , an indicator of variability were calculated from their responses. The MME is defined as the mean of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates.
A negative MME indicates an underestimation and a positive MME indicates an overestimation of the actual carbohydrate content. The MMAE is defined as the mean of the absolute value of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates.
The total PHQ-8 score is the sum of the responses to the 8 items and ranges from 0 to A lower score indicates less depression. A negative change score indicates improvement. There are 5 categories on the MDD scale: None, mild, moderate, moderately severe, and severe. The category for each participant is determined from their PHQ-8 score. A total PHQ-8 score of 0 to 4 represents no significant depressive symptoms. A total PHQ-8 score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.
A higher score indicates more depression. The total PAID scale score ranges from 0 to 80 with a higher score indicating more diabetes-related problems. The total score is the sum of the scores of the 6 items and ranges from 0 to A higher score indicates more satisfaction. This questionnaire was administered at Baseline only. The total score is the sum of the scores of the 6 items and ranges from to This questionnaire was administered at the end of the study Week 24 only.
Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Subject is on a therapy regimen that conflicts with the study:. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms x. COVID is an emerging, rapidly evolving situation. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.
Federal Government. Read our disclaimer for details. Results First Posted : February 6, Last Update Posted : February 6, Study Description. Detailed Description:. Drug Information available for: Dextrose. FDA Resources. Arms and Interventions. Outcome Measures. Participants using the Aviva Nano blood glucose meter received individualized advice in how to use their insulin:carbohydrate ratio I:CHO and insulin sensitivity factor ISF values to determine their insulin dose.
Participants were asked to assess the carbohydrate content grams of 10 standardized meals by using a set of Dose Adjustment for Normal Eating DAFNE plates, which provide standardized photographs of meals with known carbohydrate values. Eligibility Criteria. Inclusion Criteria: Must be 18 years of age or older.
Diagnosed with Type 1 or Type 2 diabetes. Subject adjusts meal insulin doses based on carbohydrate content of meals. Subject with Type 2 diabetes may be on stable metformin therapy therapy unchanged during 3 months prior to study.
Subject has been in Investigator's practice for at least 3 months but may have been seen by another physician in the practice. Subject has completed carbohydrate CHO training within the last 2 years. Exclusion Criteria: Subject is on a therapy regimen that conflicts with the study: Neutral protamine Hagedorn NPH or pre-mixed insulin; oral anti-diabetic agents, with the exception of metformin; injectable anti-diabetic agents other than long-acting insulin and rapid-acting insulin analogs or regular insulin eg, fixed dose therapy ; use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific blood glucose bG results.
Subject has participated in another interventional trial within 6 weeks prior to study. Subject has been diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease at Investigator's discretion. Subject has used systemic oral or inhaled steroids for more than 7 days within the last 3 months. Subject is on chemotherapy or radiation therapy self-reported. Subject is pregnant or lactating or is currently planning a pregnancy.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.
More Information. Publications automatically indexed to this study by ClinicalTrials. Automated bolus advisor control and usability study ABACUS : does use of an insulin bolus advisor improve glycaemic control in patients failing multiple daily insulin injection MDI therapy? BMC Fam Pract. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Not Applicable. Study Type :. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :.
Accu-Chek Aviva Expert User Manual
In the United States, approximately 6 million people take insulin to help manage their diabetes. These calculations are complex, and constant precision is critical to determine the proper insulin dose. A multicenter study found that 63 percent of manually calculated insulin doses were incorrect. Researchers from the U.
Accu-Chek Aviva Expert Quick Start Manual
Accu-Chek Aviva Expert instruction manual and user guide