DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy
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|ClinicalTrials.gov Identifier: NCT04043260|
Recruitment Status : Not yet recruiting
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
A multi center, open label, prospective study that will include up to 100 subjects with Type 1 Diabetes treated with Multiple Daily Injections (MDI) of insulin according to a predefined sliding scale plan or carbohydrate ratio (CR) and correction factor (CF) plan, and Self-Monitoring of Blood Glucose (SMBG) or Continuous Glucose Monitoring (CGM).
The study will include screening, a 3-4 weeks run-in period and a 6 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps and/or connected pens) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 9-10 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Insulin-dependent Diabetes Mellitus Diabetes Mellitus, Type 1||Device: Advisor Pro||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With Multiple Daily Injections of Insulin|
|Estimated Study Start Date :||September 8, 2019|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Subject's glucose and insulin data will be transferred to the DreaMed Advisor Pro system. Optimization of insulin treatment plan will be done using the DreaMed Advisor Pro algorithm. After approval by the study physician (may override the suggestions for safety reasons), the treatment plan will be sent to the subject to be followed for the following 3 weeks. The study team will follow-up with a phone call to the subject to verify the subject received the updated treatment plan.
Device: Advisor Pro
The DreaMed Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data which consists of glucose levels and insulin delivery history. the Advisor Pro algorithm identifies glucose patterns and their possible causes, which may hamper the patient's glucose control, and recommend on adjustment to the patient‐specific insulin treatment profiles as well as suggestions for personalized diabetes management tips (such as timing of meal boluses, bolus delivery compliance and personalized glucose targets).
- Percentage of readings below 54 mg/dl [ Time Frame: 9 weeks ]Compare percentage of readings below 54 mg/dl during 3 weeks run-in period to percentage of readings below 54 mg/dl during intervention period.
- Percentage of readings within range of 70-180 mg/dl [ Time Frame: 9 weeks ]
- Change in HbA1C post study treatment [ Time Frame: 9 weeks ]
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.gov identifier (NCT number): NCT04043260
|Contact: Yael Shtritfirstname.lastname@example.org|
|Schneider MC||Not yet recruiting|
|Petah Tikva, Israel|
|Contact: Alona email@example.com|
|Study Director:||Yael Shtrit||DreaMed Diabetes Ltd.|