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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB : 2011-A00513-38 | Other Identifier | Afssaps |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| algorithm DIAdvisor activated | Other | 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. |
|
| algorithm of DIAdvisor disactivated | Other | Glucosepredictions 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during 3 days with DIAdvisor 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of total time spent in hypoglycemia (< 70 mg/dL) | during 3 days with DIAdvisor 2 | |
| Percentage of total of time spent in hyperglycemia (>180 mg/dL) | during 3 days with DIAdvisor 2 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Clinical and Experimental Medicine | Prague | 14021 | Czechia | |||
| Montpellier University Hospital |
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| Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor) | Device | 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. |
|
| Mean of YSI blood glucose during total period, night time and meal periods |
| 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 | during 3 days with DIAdvisor 2 |
| Coherence between system advices and physician recommendations > 0.80 | during 3 days with DIAdvisor 2 |
| Score of patient survey regarding the acceptability of DIAdvisor-2 system | during 3 days with DIAdvisor 2 |
| Montpellier |
| 34000 |
| France |
| Universita Degli Studi di Padova | Padova | 35128 | Italy |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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