Clinical trial NCT03774069: The Advisor Pro Direct Study
Official title: Evaluation of Remote Consultation to Patients With Type 1 Diabetes Under Continuous Glucose Sensors and Insulin Pump Therapy Using the DreaMed Advisor Pro. An Open Label, Randomized Non-inferiority Study of Insulin Pump Therapy Adjustments Between DreaMed Advisor Pro and Standard of Care-The Advisor Pro Direct Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Insulin pump treatment
Type 1 diabetes
Pump setting advisor
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: DreaMed
First posted: 2018-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 decision- support software intended for assisting healthcare professionals in the management of type 1 diabetes patients who use insulin pumps as their insulin delivery therapy and monitor their blood glucose levels using CGM (Continuous Glucose Monitoring) or CGM and self-management blood glucose meter.

The main objective of the proposed study is to test the safety, reliability, and efficacy of the DreaMed Advisor Pro algorithm when the recommendation is sent directly to the patient without a physician review.

Participants will be randomized in a 1:1 ratio to either the intervention group (DreaMed Advisor Pro) or control group (standard of care). Participants will download the CGM and pump data at no less frequent than every 4 weeks for both groups during the 3 months period of the study.

Each time new data is received, the following actions will be performed:

In the intervention group, a new algorithm recommendation for pump settings will be issued. The recommendation will be approved by a technical, non-physician to assure that glucose data are not fall within predefined safety criteria which require a physician approval before the recommendation will be sent to the patient, otherwise, recommendation will be sent directly to the patient.

In the control group, if no safety criteria is met, it is the responsibility of the patient to contact his/her physician to advise on change of treatment. In case a safety issue has occurred, the physician will contact the patient and change the pump settings.

Prior to initiating the interventional phase of the study, we will evaluate the experience of patients in self adjustments of insulin dosing in regular care management and to evaluate their acceptance for using an automated dosing recommendations software. The evaluation will be done by asking patients/caregivers to fill 15 questions survey. 100 patients are anticipated to participate in this phase of the study.


Eligibility criteria: Inclusion Criteria:

1. Subject with type 1 diabetes (\>1 yr diagnosis)
2. Age- 6-30 years old
3. HbA1c equals or above 7% and equals or below 10%
4. 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.
5. BMI below 30 kg/m\^2
6. 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)
7. Patients are required to have minimum computer skills and understanding of navigating the internet.
8. Patients are required to know basic English.
9. Patients willing to use glucose sensor for study duration.
10. Patients will have to have a smartphone (Apple or Android) or PC with email account.

Exclusion Criteria:

1. An episode of diabetic ketoacidosis within the month prior to study entry
2. 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.
3. Current participation in any other interventional study.
4. Known or suspected allergy to trial products such as adhesives, tapes, needles.
5. Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
6. 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.
7. 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.
8. Hypoglycemia unawareness
9. 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
10. Patient suffers from eating disorder. -

Primary outcomes:
measure: Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10mmol/L)
timeFrame: Final visit (week 12)
measure: Percentage of readings below 54 mg/dl (3.3 mmol/l)
timeFrame: Final visit (week 12)
Secondary outcomes:
measure: HbA1c
timeFrame: Final visit (week 12)
measure: Diabetes treatment satisfaction questionnaire
timeFrame: Final visit (week 12)
measure: Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)
timeFrame: Final visit (week 12)
measure: Percentage of readings below 60 mg/dl (3.35mmol/L)
timeFrame: Final visit (week 12)
measure: Percentage of readings above 180 mg/dl (10.0mmol/L)
timeFrame: Final visit (week 12)
measure: percentage of readings above 250 mg/dl (13.9 mmol/L)
timeFrame: Final visit (week 12)
measure: Area above the curve of glucose level of 180 mg/dl
timeFrame: Final visit (week 12)
measure: Area above the curve of glucose level above180 mg/dl
timeFrame: Final visit (week 12)
measure: Area under the curve of glucose level of 70 mg/dl
timeFrame: Final visit (week 12)
measure: Area under the curve of glucose level below 70 mg/dl
timeFrame: Final visit (week 12)
measure: Mean sensor blood glucose
timeFrame: Final visit (week 12)
measure: Glucose variability measured by standard deviation
timeFrame: Final visit (week 12)
measure: Number of recommendations sent to patient in the last 6 months prior to baseline and during intervention period
timeFrame: Final visit (week 12)
measure: Number of recommendations for changes in settings per patient
timeFrame: Final visit (week 12)
measure: Number of recommendations for changes in settings per iteration
timeFrame: Final visit (week 12)
measure: Number of physician override Advisor recommendation
timeFrame: Final visit (week 12)
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schnider Children's medical center
Study officials:
References: