Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
| DreaMed Diabetes | INDUSTRY |
Not provided
Not provided
Not provided
The study comprises of two segments: a feasibility segment and a Proof of Concept segment. The study is open label, prospective study that will include up to 72 subjects in segment 1 and up to 40 subjects in segment 2. Participants are people with Type 1 or type 2 Diabetes treated with Multiple Daily Injections ( MDI) and Self Monitoring of Blood Glucose (SMBG) or intermittent Continuous Glucose Monitoring (CGM).
The study will include screening, a 2-4-week run-in period and 10-12 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps ) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 12-16 weeks.
The goal of this study is to evaluate the safety of a decision support system for adjustment of insulin treatment plan for people with diabetes using multiple daily injections and monitoring glucose by SMBG or intermittent CGM
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 Decision Support System-MDI algorithm. During the feasibility segment an approval of the study physician (may override the suggestions for safety reasons) will be required prior to sending the recomendations to participants. During the Proof of Concept segment, the recomendations will be sent directly to participants. Participants will be asked to follow the tretment plan for the following 2.5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DreaMed Advisor Pro DSS-MDI algorithm | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Sensor glucose percentage of time in hypoglycemia below 54 mg/dl | 12-16 weeks | |
| Sensor glucose percentage of time in hyperglycemia above 250 mg/dl | 12-16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of readings within range of 70-180 mg/dl | 12-16 weeks | |
| Change in HbA1C post study treatment | 12-16 weeks | |
| Number of Serious Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of readings above 180 mg/dl | 12-16 weeks | |
| Percentage of readings below 70 mg/dl | 12-16 weeks | |
| Mean sensor glucose |
Inclusion Criteria:
Documented Type 1 or Type 2 Diabetes for at least 1 year prior to study enrolment
Aged ≥ 14 years
HbA1c of 6.5 ≤ A1c ≤ 10%
Using basal-bolus MDI therapy:
Subjects willing to follow study instructions:
Subjects using CGM or SMBG that are compatible with data transmission to the study diabetes management system (i.e. for CGM, FGM with a reader).
Fasting glucose target is < = 180 mg/dl (T2D)
Subjects have home computer connected to the internet.
Subjects have a smart phone compatible with study requirements.
Subjects willing and able to sign a written informed consent form.
Exclusion Criteria:
An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.
Concomitant diseases/ treatment that influence metabolic control or any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety
Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:
Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
Drug or alcohol abuse.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moshe Phillip, MD | Contact | 972-544-795995 | moshe.phillip@phillipmd.com | |
| Alona Hamou, MSc | Contact | 972-3-9253282 | alonah@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, MD | Rabin Medical Center | Study Director |
| Revital Nimri, MD | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| schneider children medical center of Israel | Recruiting | Petah Tikva | 49202 | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 12-16 weeks |
| 11 weeks |
| Glucose variability | 12-16 weeks |
| Number of recommendations for changes in the treatment plan per patient | 12-16 weeks |
| Number of recommendations for changes in the treatment plan per iteration | 12-16 weeks |
| Number of physician overrides of the study system recommendations segment 1 only | 12-16 weeks |
| Number of physician overrides of the study system recommendations | 12-16 weeks |
| Total insulin dose | 12-16 weeks |
| The amount of basal insulin dose | 12-16 weeks |
| The amount of bolus insulin dose | 12-16 weeks |
| Rabin Medical Center- Belinson | Recruiting | Petah Tikva | Israel |
|