Status:
TERMINATED
The Advisor Pro Direct Study
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
DreaMed
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The DreaMed Advisor Pro is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. DreaMed Advisor Pro is a decisi...
Eligibility Criteria
Inclusion
- Subject with type 1 diabetes (\>1 yr diagnosis)
- Age- 6-30 years old
- HbA1c equals or above 7% and equals or below 10%
- Insulin infusion pump CSII (Continuous Subcutaneous Inulin Infusion) therapy for at least 4 months and current treatment with one of the following pumps: Omnipod Insulet (Bedford, MA), Medtronic Minimed Veo insulinPump (MMT-754, MMT-554), Medtronic 640G or Animas.
- BMI below 30 kg/m\^2
- Patients willing to follow study instructions (willing to measure capillary blood glucose as required by their glucose sensor for calibration and use the bolus- calculator feature of the pump)
- Patients are required to have minimum computer skills and understanding of navigating the internet.
- Patients are required to know basic English.
- Patients willing to use glucose sensor for study duration.
- Patients will have to have a smartphone (Apple or Android) or PC with email account.
Exclusion
- An episode of diabetic ketoacidosis within the month prior to study entry
- 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 patient's safety.
- Current participation in any other interventional study.
- Known or suspected allergy to trial products such as adhesives, tapes, needles.
- Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
- Severe hypoglycemia within six months prior to enrollment as defined by the ADA and Endocrine society as follows: Severe hypoglycaemia is an event requiring assistance of another person (due to change in mental status) to actively administer carbohydrates, glucagon, or take othe corrective actions.
- Current use of the following medications: medications that are use to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- Hypoglycemia unawareness
- Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus.
- Subject has unstable or rapidly progressive renal disease or is receiving dialysis.
- Subject has active proliferative retinopathy.
- Active gastroparesis
- Patient suffers from eating disorder. -
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03774069
Start Date
December 1 2020
End Date
December 1 2023
Last Update
November 19 2025
Active Locations (1)
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1
Schnider Children's medical center
Petah Tikva, Israel, 49202