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AI-Powered diabetes coach could replace some doctor visits

NCT ID NCT03774069

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a software called DreaMed Advisor Pro that automatically analyzes blood sugar and insulin pump data to suggest insulin dose adjustments. About 100 people with type 1 diabetes (ages 6-30) were split into two groups: one received recommendations directly from the software, the other followed standard care with their doctor. The goal was to see if the software could safely and effectively manage blood sugar levels without a doctor's review.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Dec 2020

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. -

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Schnider Children's medical center

    Petah Tikva, 49202, Israel

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