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Can a glucose app that predicts lows calm diabetes fears?

NCT ID NCT07814508

Symptom relief Sponsor: FIDAM RDC Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers test whether adding a predictive app to a continuous glucose monitor changes fear of low blood sugar, sleep quality, and diabetes distress in adults with type 1 or insulin-treated type 2 diabetes. Participants use the monitor alone for two weeks, then with the app for four weeks. They answer questionnaires and smartphone prompts about their experiences, and a small group joins interviews.

What this could mean

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

Active substance
Accu-Chek SmartGuide continuous glucose monitoring system with the Predict App
What this could lead to
If the predictive app helps, it could give people with diabetes a way to feel less afraid of low blood sugar and manage daily life with more confidence.
What could go wrong
This is a small, short study without a control group, so improvements may come from paying attention rather than the app. The results may not apply to everyone with diabetes.

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 89 people

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

Started

Feb 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: * Type 1 diabetes or Type 2 diabetes with intensified insulin therapy (defined as basal-bolus therapy with self-adjustment of bolus doses) * CGM use during the past 3 months (without predictive features) * Age ≥ 18 years * HbA1c \< 10% * Informed consent Exclusion Criteria: * Use of the SmartGuide CGM solution * AID use * Current treatment with psychiatric medications * Diabetes duration \< 3 months * Current or planned pregnancy * Peripheral neuropathy that will impact sleep quality according to the judgement of the participant * Severe complications (e.g. kidney disease, cancer)

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Conditions

The condition(s) this trial relates to.

diabetes mellitus insomnia type 1 diabetes mellitus type 1 diabetes mellitus 1 type 2 diabetes mellitus

As listed by the trial registrant

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

Continuous glucose monitoring system Diabetes (DM) Diabetes distress Diabetes mellitus Diabetes mellitus ( type 1 and type 2) Diabetes mellitus type 2 Diabetes mellitus, type 1 Ecological momentary assessment Fear of hypoglycemia Glucose control Glycemic responses Glycemic variability Prediction Sleep quality

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Fidam Rdc

    RECRUITING

    Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

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