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The Advisor Pro Direct Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774069
Recruitment Status : Not yet recruiting
First Posted : December 12, 2018
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
DreaMed
Information provided by (Responsible Party):
Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE December 11, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date June 11, 2020
Estimated Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10mmol/L) [ Time Frame: Final visit (week 12) ]
  • Percentage of readings below 54 mg/dl (3.3 mmol/l) [ Time Frame: Final visit (week 12) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
  • HbA1c [ Time Frame: Final visit (week 12) ]
  • Diabetes treatment satisfaction questionnaire [ Time Frame: Final visit (week 12) ]
    The questionnaire contains 12-14 items (12 for the teens version and 14 for the parents version) the subscale for each items is from 0 to 6, and for most items the the higher the score, the greater the satisfaction with the treatment.Subscales are summed. More specific instruction for analysis are detailed in Diabetologia 52:(suppl 1) S397, Abstruct 1013 and in a document named "Summary of recommended scoring" by Prof. Bradley, University of London
  • Percentage of glucose readings below 70 mg/dl (3.9 mmol/L) [ Time Frame: Final visit (week 12) ]
  • Percentage of readings below 60 mg/dl (3.35mmol/L) [ Time Frame: Final visit (week 12) ]
  • Percentage of readings above 180 mg/dl (10.0mmol/L) [ Time Frame: Final visit (week 12) ]
  • percentage of readings above 250 mg/dl (13.9 mmol/L) [ Time Frame: Final visit (week 12) ]
  • Area above the curve of glucose level of 180 mg/dl [ Time Frame: Final visit (week 12) ]
  • Area above the curve of glucose level above180 mg/dl [ Time Frame: Final visit (week 12) ]
  • Area under the curve of glucose level of 70 mg/dl [ Time Frame: Final visit (week 12) ]
  • Area under the curve of glucose level below 70 mg/dl [ Time Frame: Final visit (week 12) ]
  • Mean sensor blood glucose [ Time Frame: Final visit (week 12) ]
  • Glucose variability measured by standard deviation [ Time Frame: Final visit (week 12) ]
  • Number of recommendations sent to patient in the last 6 months prior to baseline and during intervention period [ Time Frame: Final visit (week 12) ]
  • Number of recommendations for changes in settings per patient [ Time Frame: Final visit (week 12) ]
  • Number of recommendations for changes in settings per iteration [ Time Frame: Final visit (week 12) ]
  • Number of physician override Advisor recommendation [ Time Frame: Final visit (week 12) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • HbA1c [ Time Frame: Final visit (week 12) ]
  • Diabetes treatment satisfaction questionnaire [ Time Frame: Final visit (week 12) ]
  • Percentage of glucose readings below 70 mg/dl (3.9 mmol/L) [ Time Frame: Final visit (week 12) ]
  • Percentage of readings below 60 mg/dl (3.35mmol/L) [ Time Frame: Final visit (week 12) ]
  • Percentage of readings above 180 mg/dl (10.0mmol/L) [ Time Frame: Final visit (week 12) ]
  • percentage of readings above 250 mg/dl (13.9 mmol/L) [ Time Frame: Final visit (week 12) ]
  • Area above the curve of glucose level of 180 mg/dl [ Time Frame: Final visit (week 12) ]
  • Area above the curve of glucose level above180 mg/dl [ Time Frame: Final visit (week 12) ]
  • Area under the curve of glucose level of 70 mg/dl [ Time Frame: Final visit (week 12) ]
  • Area under the curve of glucose level below 70 mg/dl [ Time Frame: Final visit (week 12) ]
  • Mean sensor blood glucose [ Time Frame: Final visit (week 12) ]
  • Glucose variability measured by standard deviation [ Time Frame: Final visit (week 12) ]
  • Number of recommendations sent to patient in the last 6 months prior to baseline and during intervention period [ Time Frame: Final visit (week 12) ]
  • Number of recommendations for changes in settings per patient [ Time Frame: Final visit (week 12) ]
  • Number of recommendations for changes in settings per iteration [ Time Frame: Final visit (week 12) ]
  • Number of physician override Advisor recommendation [ Time Frame: Final visit (week 12) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Advisor Pro Direct Study
Official Title  ICMJE 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
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 occured, the physician will contact the patient and change the pump settings.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Device: DreaMed Advisor Pro
    Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro and sent directly to the patient
  • Other: Medical guided recommendation
    Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team according to standard of care
Study Arms  ICMJE
  • Experimental: DreaMed Advisor Pro
    Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor pro.
    Intervention: Device: DreaMed Advisor Pro
  • Active Comparator: Control group- medical guided recommendation
    Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted by the medical team
    Intervention: Other: Medical guided recommendation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject with type 1 diabetes (>1 yr diagnosis)
  2. Age- 18 years and above
  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. -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Moshe Phillip, Prof 972-3-9253282 mosheph@clalit.org.il
Contact: Alona Hamou, Msc 972-54-5950277 alonah@clalit.org.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03774069
Other Study ID Numbers  ICMJE RMC040818ctil
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE DreaMed
Investigators  ICMJE Not Provided
PRS Account Rabin Medical Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP