DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy
DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy
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.
Inclusion Criteria:

 1. Documented T1D for at least 1 year prior to study enrolment

 2. Subjects aged 18 - 65 years old

 3. A1c at inclusion ≤ 10%

 4. Subjects using basal-bolus MDI therapy:

 1. Basal insulin: Glargine, Degludec, or Determir

 2. Bolus insulin: regular insulin, rapid analogues or ultra-rapid analogues

 5. Subjects using CGM or SMBG that are compatible with data transmission to the study
 DMS.

 6. BMI < 28 kg/m2

 7. Subjects willing to follow study instructions:

 1. For SMBG users: measure capillary blood glucose at least 4 times a day and twice
 a week 7-point profile (optional). Document blood glucose level, insulin
 delivery, meals and daily activities. Wear blinded CGM.

 2. For CGM users: Use CGM according to manufacture instructions, Document insulin
 delivery, meals and daily activities.

 8. Subjects have connection to the internet at home.

 9. Subjects have a smartphone compatible with study requirements

 10. Subjects willing and able to sign a written informed consent form.

 Exclusion Criteria:

 1. 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.

 2. 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

 3. Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic
 foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:

 -  Subject has unstable or rapidly progressive renal disease or is receiving
 dialysis

 -  Subject has active proliferative retinopathy

 -  Active gastroparesis

 4. Participation in any other interventional study

 5. Female subject who is pregnant or planning to become pregnant within the planned study
 duration

 6. Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.

 7. Drug or alcohol abuse.