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AI coach for diabetes: small study tests personalized insulin advice

NCT ID NCT03186300

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 smartphone-based tool called PEPPER that gives personalized insulin dose advice to people with type 1 diabetes. The tool uses artificial intelligence to learn from each person's past data and includes safety features like low-glucose alarms. Eight adults used the system to see if it was safe, easy to use, and worked well in daily life. The main goal was to measure how much time they spent with low blood sugar.

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

8 people

The number who actually took part.

Started

Sep 2017

Finished

Dec 2018

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: * Adults ≥18years of age * Diagnosis of T1DM for \> 1 year * On MDI using a basal-bolus insulin regime or CSII (insulin pump) for at least 6 month * Structured education done and good ability perform carbohydrates (CHO) counting * HbA1c ≥ 48mmol/mol and ≤ 86mmol/mol * Using insulin carbohydrates ratio (ICR) and insulin sensitivity factor (ISF) to calculate the mealtime bolus * An understanding of and willingness to follow the protocol and sign the informed consent * CBG measurements at least 2 times per day for calibration of the CGM Exclusion Criteria: * Severe episode of hypoglycaemia (requiring 3rd party assistance) in the 6 months prior to enrolment * Diabetic ketoacidosis in the last 6 months prior to enrolment * Impaired awareness of hypoglycaemia (based on Clarke score) * Pregnancy, breastfeeding or intention of becoming pregnant over time of study procedures * Enrolled in other clinical trials * Have active malignancy or under investigation for malignancy * Suspected or diagnosed endocrinopathy like adrenal insufficiency, unstable thyroidopathy, endocrine tumour * Gastroparesis * Autonomic neuropathy * Macrovascular complications (acute coronary syndrome, transient ischaemic attack, cerebrovascular event within the last 12 months prior to enrolment in the study) * Visual impairment including unstable proliferative retinopathy * Reduced manual dexterity * Inpatient psychiatric treatment * Abnormal renal function test results (calculated Glomerular Filtration Rate (GFR) \<40 mL/min/1.73m2) * Liver cirrhosis * Not tributary to optimization to insulin therapy * Abuse of alcohol or recreational drugs * Oral steroids * Regular use of the acetaminophen, beta-blockers or any other medication that the investigator believes is a contraindication to the participant's participation. Participant withdrawal criteria: * Loss of capacity to give informed consent * The subject has a serious event related to study * Cessation of MDI of insulin as usual care for T1DM * Severe hypoglycaemia * Diabetic ketoacidosis * Positive pregnancy test * Terminal illness * Investigators initiated discontinuation of study due to participant or equipment concerns

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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

  • Institut d'Investigació Biomèdica de Girona (IDIBGI)

    Girona, Girona, 17007, Spain

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