Type 1 Diabetes MellitusNCT03774069
The Advisor Pro Direct Study
A study testing DreaMed Advisor Pro and Medical guided recommendation in people with Type 1 Diabetes Mellitus, run by Rabin Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- DreaMed Advisor Pro and Medical guided recommendation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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. -
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read more
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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- DreaMed Advisor Pro, Medical guided recommendation
- Keywords
- Insulin pump treatment, Type 1 diabetes, Pump setting advisor
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DreaMed Advisor ProDevice
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
Medical guided recommendationOther
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 group | Role | What they receive |
|---|---|---|
| DreaMed Advisor Pro | Experimental | Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor pro. Receives: Device: DreaMed Advisor Pro |
| Control group- medical guided recommendation | Active comparator | Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted by the medical team Receives: Other: Medical guided recommendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10mmol/L)
Measured: Final visit (week 12)
Percentage of readings below 54 mg/dl (3.3 mmol/l)
Measured: Final visit (week 12)
Secondary outcomes (16)
HbA1c
Measured: Final visit (week 12)
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
Measured: Final visit (week 12)
Percentage of glucose readings below 70 mg/dl (3.9 mmol/L)
Measured: Final visit (week 12)
Percentage of readings below 60 mg/dl (3.35mmol/L)
Measured: Final visit (week 12)
Percentage of readings above 180 mg/dl (10.0mmol/L)
Measured: Final visit (week 12)
percentage of readings above 250 mg/dl (13.9 mmol/L)
Measured: Final visit (week 12)
Area above the curve of glucose level of 180 mg/dl
Measured: Final visit (week 12)
Area above the curve of glucose level above180 mg/dl
Measured: Final visit (week 12)
Area under the curve of glucose level of 70 mg/dl
Measured: Final visit (week 12)
Area under the curve of glucose level below 70 mg/dl
Measured: Final visit (week 12)
Mean sensor blood glucose
Measured: Final visit (week 12)
Glucose variability measured by standard deviation
Measured: Final visit (week 12)
Number of recommendations sent to patient in the last 6 months prior to baseline and during intervention period
Measured: Final visit (week 12)
Number of recommendations for changes in settings per patient
Measured: Final visit (week 12)
Number of recommendations for changes in settings per iteration
Measured: Final visit (week 12)
Number of physician override Advisor recommendation
Measured: Final visit (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start1 Dec 2020
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Why it stopped: It was finally decided not to perform the interventional part of the study. Only the questionnaire's part was performed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- DreaMed
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774069
- Sponsor's protocol ID
- RMC040818ctil
- Status last verified
- Nov 2025
- First submitted
- 11 Dec 2018
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03774069
- Acronym / sponsor ID
- RMC040818ctil
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Insulin pump treatment, Type 1 diabetes, Pump setting advisor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was finally decided not to perform the interventional part of the study. Only the questionnaire's part was performed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- DreaMed
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DreaMed Advisor Pro | Experimental | Device: DreaMed Advisor ProInsulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor pro. |
| Control group- medical guided recommendation | Active comparator | Other: Medical guided recommendationInsulin pump settings (i.e, basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted by the medical team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DreaMed Advisor ProInsulin 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 | Device | DreaMed Advisor Pro |
| Medical guided recommendationInsulin 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 | Other | Control group- medical guided recommendation |
Primary outcome
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)
16 secondary outcomes
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)
Results and safety
The study was stopped early (reason given: It was finally decided not to perform the interventional part of the study. Only the questionnaire's part was performed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DreaMed Advisor Pro and Medical guided recommendation in people with Type 1 Diabetes Mellitus, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It was finally decided not to perform the interventional part of the study. Only the questionnaire's part was performed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of glucose readings within range of 70-180 mg/dl (3.9 to 10mmol/L) (time frame: Final visit (week 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.