| Outcome Measures: |
Primary: Change in TIR (70-180 mg/dl), Measured in percentage by Continuous glucose monitor (CGM), Baseline, 52 weeks | Secondary: Change in Time in high range (180-250 mg/dl), Measured in percentage by Continuous glucose monitor (CGM), Baseline, 52 weeks|Change in Time in very high range (>250 mg/dl), Measured in percentage by Continuous glucose monitor (CGM), Baseline, 52 weeks|Change in Time in low range (54-69 mg/dl), Measured in percentage by Continuous glucose monitor (CGM), Baseline, 52 weeks|Change in Time in very low range (<54 mg/dl), Measured in percentage by Continuous glucose monitor (CGM), Baseline, 52 weeks|Proportion of participants with TIR 70-180 mg/dl for 70% of the day, Measured in percentage by CGM, 52 weeks|Proportion of participants with TIR 70-180 mg/dl with more than equal to 5% improvement from baseline, Measured in percentage by CGM, 52 weeks|Proportion of participants with Time below range <70 mg/dL for <4% of each day, Measured in percentage by CGM, 52 weeks|Proportion of participants with Time below range <54 mg/dL for <1% of each day, Measured in percentage by CGM, 52 weeks|Proportion of participants with Time above range >180 mg/dL for <25% of each day, Measured in percentage by CGM, 52 weeks|Change in haemoglobin A1c (HbA1c), Measured in percentage, Baseline, 52 weeks|Total daily dose of insulin, Measured as units/day, 52 weeks|Number of oral glucose lowering agents, Measured as count, 52 weeks|Proportion of participants with >10 points improvement in % TIR 70-180 mg/dL without an increase in time below range <54 mg/dL of >0.5%, Measured in percentage, 52 weeks|Proportion of participants with mean glucose <154 mg/dL and <1% time below range <54 mg/dL, Measured in percentage, 52 weeks|Number of participants with Severe hypoglycemia, Measured in count, 52 weeks|Change in body weight, Measured in kilograms, Baseline, 52 weeks|Change in waist circumference, Measured in centimeters, Baseline, 52 weeks|Change in percentage total body fat, Measured in percentage, Baseline, 52 weeks|Change in percentage lean mass, Measured in percentage, Baseline, 52 weeks|Change in Inter-dialysis weight gain, Measured in kilograms, Baseline, 52 weeks|Number of participants hospitalized, Measured in count, 52 weeks|Total number of days spent in hospital, Measured in count, 52 weeks|Total score of Diabetes Treatment Satisfaction questionnaire, Patient reported outcomes is assessed by Diabetes Treatment Satisfaction Score questionnaire which assesses patient satisfaction with diabetes treatment. It is composed of eight questions, each of which is scored by patients on a scale ranging from zero (e.g., "very dissatisfied", "very inconvenient") to six (e.g., "very satisfied", "very convenient"). Treatment satisfaction is assessed as the sum of the scores of the six questions on the first factor, with a higher score indicating higher treatment satisfaction., 52 weeks|Total score of EQ-5D-5L, The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Possible scores range from 0-100, where higher score indicate better outcome, 52 weeks|Total score of Kidney disease QoL short form, The KDQOL-SF is a self-report measure developed for individuals with kidney disease and those on dialysis. It is a shorter version of a measure developed by the same authors. It includes 43 kidney disease-targeted items, such as the effects of the disease of activities of daily living, work status, and social interaction, and 36 items that provide a measure of physical and mental health, and 1 overall health rating item ranging from 0 ("worst possible health") to 10 ("best possible health.")., 52 weeks
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| Locations: |
University of North Carolina, Chapel Hill, North Carolina, 27599, United States|Davita UT Southwestern - Oak Cliff, Dallas, Texas, 75224, United States|DaVita UT Southwestern - East Dallas, Dallas, Texas, 75228, United States|DaVita UT Southwestern - Preston, Dallas, Texas, 75240, United States|DaVita UT Southwestern - Irving, Irving, Texas, 75062, United States
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