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Smartphone app tracks stress to uncover diabetes blood sugar mystery

NCT ID NCT06896045

Knowledge-focused Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at how everyday stress impacts blood sugar levels in people with type 1 diabetes. Researchers will ask 125 participants to rate their stress four times a day using a smartphone app, while a continuous glucose monitor tracks their blood sugar. The goal is to see if there is a clear link between stress and glucose changes, which could help improve diabetes care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors and patients understand how stress impacts blood sugar, potentially leading to better diabetes management strategies.
What could go wrong
This is an observational study, not a treatment trial. It is currently suspended, and results may not lead to immediate changes in care.

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

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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: * Patient with a clinical diagnosis of type 1 diabetes of at least 1 year, as determined by the medical record; * Patient aged at least 18 years; * Patient treated with an external insulin pump for at least 2 months or with multi-injections; * Patient with a smartphone compatible with iOS 15.0 or higher or Android 12.0 or higher; * Patient with a smartphone with Bluetooth 5.0 or higher; * Patient with HbA1c ≤ 10% with measurement ≤3 months; * Patient with no psychiatric pathology that could interfere with the study; * Patient having signed the free and informed consent form to participate in the study; * Patient affiliated to the French Social Security system; * Patient agreeing not to eat between meals for the duration of the study (except for hypoglycaemia and/or snacks during physical activity); * Patient agrees to wear an Empatica EmbracePlus watch for the duration of the study and to charge it according to the device's requirements for recording data; * Patient agreed to wear an OURA ring for the duration of the study and to recharge it as required by the device to enable data recording (patients at the CERITD centre only). Exclusion Criteria: * Type 2 diabetic patient; * Patient fitted with a closed loop (or artificial pancreas); * Patient with any characteristic pathology that could interfere with the study (renal failure, unstabilised diabetic retinopathy, heart failure, heart attack within 6 months prior to inclusion, severe neuropathy, particularly autonomic neuropathy); * Patients with a tendency to snack; * Patients undergoing treatment with drugs known to significantly interfere with blood sugar levels or the adrenergic system, such as corticosteroids and beta-blockers; * Patients undergoing atropine treatment (Hydroxyzine Chlorhydrate or Atarax®...), likely to modify the EDA (Electrodermal Activity) ; * Patients with a known allergy to latex (watch EmbracePlus); * Pregnant woman; * Nursing woman; * Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care; * Persons under guardianship or trusteeship or subject to a legal protection measure * Persons who are not affiliated to a social security scheme or are beneficiaries of such a scheme.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

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

Diabetes type 1

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Angers University Hospital

    Angers, 49100, France

  • Avignon Hospital

    Avignon, 84000, France

  • Bordeaux University Hospital

    Bordeaux, 33075, France

  • Brest University Hospital

    Brest, 29200, France

  • CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète)

    Évry, 91058, France

  • DiabeCare diabetes centre

    Lyon, 69008, France

  • Dijon University Hospital

    Dijon, 21079, France

  • European Hospital

    Marseille, 13003, France

  • Grenoble University Hospital

    Grenoble, 38043, France

  • Lille University Hospital

    Lille, 59037, France

  • Private practice in endocrinology and metabolic diseases

    Mérignac, 33700, France

  • Rennes University Hospital

    Rennes, 35200, France

  • St Louis Hospital

    La Rochelle, 17000, France

  • Strasbourg University Hospital

    Strasbourg, 67091, France

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