The primary purpose of this study is to see whether a tool that predict blood glucose and suggest therapy advices can help type 1 diabetic patients.
During this study, we would like to assess the efficacy in keeping blood glucose in a safe range (70-180 mg/dL) of the second generation of a Glucose Predictive and Therapy Advisory system in diabetic patients treated by basal-bolus insulin regimens using pumps or multiple daily injections. We want to compare the time spent in safe range while using the predictor and advisor outputs and when the patient is not using them. This is a randomized controlled crossover trial. Patient will come for two admissions of 3 days, one with the DIAdvisor system fully activated, and one with the prediction and advice features disabled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Glucose predictions and therapy advices will not be displayed. Patient will decide his need of insulin according to the results given by the HemoCue glucometer and CGM trends. He/She will inject insulin at mealtimes or program a bolus on his/her pump by him/herself and will adapt his/her basal insulin doses or pump delivery rates as usual. As needed or on request and more particularly if hypo or hyperglycaemia occurs, the subject will be advised and helped by nurses and physicians.
Glucose predictions and therapy advices will be displayed to the patient. Patients will be asked to follow the advices suggested by DIAdvisor system according to their own judgement. Patient will decide his need of insulin according to the results given by the HemoCue glucometer, CGM trends, glucose predictions as well as therapy advices. In case of any doubt with the predictions displayed or the advices suggested, the patients will be invited to ask study personal and/or the study physician for help.
Institute for Clinical and Experimental Medicine
Prague, Czechia
Montpellier University Hospital
Montpellier, France
Universita Degli Studi di Padova
Padova, Italy
Percentage of total time spent by patients in safe range (70-180mg/dL)
The primary endpoint is the percentage of total time spent by patients in safe range (70-180mg/dL). A clinically significant benefit will be reached if an increase of at least 10% of total time in range is obtained while using DIAdvisor-2.
Time frame: during 3 days with DIAdvisor 2
Percentage of total time spent in hypoglycemia (< 70 mg/dL)
Time frame: during 3 days with DIAdvisor 2
Percentage of total of time spent in hyperglycemia (>180 mg/dL)
Time frame: during 3 days with DIAdvisor 2
Mean of YSI blood glucose during total period, night time and meal periods
Time frame: during the two 3 days-hospitalizations
Percentage paired glucose values
Percentage paired glucose values: Predicted glucose t+20min vs. real glucose t to t+20min in A\&B zones of EGA \> 80% AND \< 5% in E zone of EGA
Time frame: during 3 days with DIAdvisor 2
Coherence between system advices and physician recommendations > 0.80
Time frame: during 3 days with DIAdvisor 2
Score of patient survey regarding the acceptability of DIAdvisor-2 system
Time frame: during 3 days with DIAdvisor 2
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