Back to results

The Advisor Pro Direct Study

Primary Purpose

Type 1 Diabetes Mellitus

Status

Active

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

DreaMed Advisor Pro

Medical guided recommendation

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Insulin pump treatment, Type 1 diabetes, Pump setting advisor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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. -

Sites / Locations

Schnider Children's medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DreaMed Advisor Pro

Control group- medical guided recommendation

Arm Description

Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor pro.

Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted by the medical team

Outcomes

Primary Outcome Measures

Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10mmol/L)

Percentage of readings below 54 mg/dl (3.3 mmol/l)

Secondary Outcome Measures

HbA1c

Diabetes treatment satisfaction questionnaire

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)

Percentage of readings below 60 mg/dl (3.35mmol/L)

Percentage of readings above 180 mg/dl (10.0mmol/L)

percentage of readings above 250 mg/dl (13.9 mmol/L)

Area above the curve of glucose level of 180 mg/dl

Area above the curve of glucose level above180 mg/dl

Area under the curve of glucose level of 70 mg/dl

Area under the curve of glucose level below 70 mg/dl

Mean sensor blood glucose

Glucose variability measured by standard deviation

Number of recommendations sent to patient in the last 6 months prior to baseline and during intervention period

Number of recommendations for changes in settings per patient

Number of recommendations for changes in settings per iteration

Number of physician override Advisor recommendation

Full Information

NCT ID

NCT03774069

First Posted

December 11, 2018

Last Updated

March 15, 2023

Sponsor

Rabin Medical Center

Collaborators

DreaMed

1. Study Identification

Unique Protocol Identification Number

NCT03774069

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rabin Medical Center

Collaborators

DreaMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

Insulin pump treatment, Type 1 diabetes, Pump setting advisor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DreaMed Advisor Pro

Arm Type

Experimental

Arm Description

Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor pro.

Arm Title

Control group- medical guided recommendation

Arm Type

Active Comparator

Arm Description

Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted by the medical team

Intervention Type

Device

Intervention Name(s)

DreaMed Advisor Pro

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Medical guided recommendation

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10mmol/L)

Time Frame

Final visit (week 12)

Title

Percentage of readings below 54 mg/dl (3.3 mmol/l)

Time Frame

Final visit (week 12)

Secondary Outcome Measure Information:

Title

HbA1c

Time Frame

Final visit (week 12)

Title

Diabetes treatment satisfaction questionnaire

Description

Time Frame

Final visit (week 12)

Title

Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)

Time Frame

Final visit (week 12)

Title

Percentage of readings below 60 mg/dl (3.35mmol/L)

Time Frame

Final visit (week 12)

Title

Percentage of readings above 180 mg/dl (10.0mmol/L)

Time Frame

Final visit (week 12)

Title

percentage of readings above 250 mg/dl (13.9 mmol/L)

Time Frame

Final visit (week 12)

Title

Area above the curve of glucose level of 180 mg/dl

Time Frame

Final visit (week 12)

Title

Area above the curve of glucose level above180 mg/dl

Time Frame

Final visit (week 12)

Title

Area under the curve of glucose level of 70 mg/dl

Time Frame

Final visit (week 12)

Title

Area under the curve of glucose level below 70 mg/dl

Time Frame

Final visit (week 12)

Title

Mean sensor blood glucose

Time Frame

Final visit (week 12)

Title

Glucose variability measured by standard deviation

Time Frame

Final visit (week 12)

Title

Number of recommendations sent to patient in the last 6 months prior to baseline and during intervention period

Time Frame

Final visit (week 12)

Title

Number of recommendations for changes in settings per patient

Time Frame

Final visit (week 12)

Title

Number of recommendations for changes in settings per iteration

Time Frame

Final visit (week 12)

Title

Number of physician override Advisor recommendation

Time Frame

Final visit (week 12)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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. -

Facility Information:

Facility Name

Schnider Children's medical center

City

Petach Tikva

ZIP/Postal Code

49202

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Advisor Pro Direct Study

We'll reach out to this number within 24 hrs