Multicenter Study Evaluating the Relationship Between Perceived Daily Stress Level and Glycemic Level in Subjects With Type 1 Diabetes

Launched by CENTRE D'ETUDES ET DE RECHERCHE POUR L'INTENSIFICATION DU TRAITEMENT DU DIABÈTE · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how daily stress levels affect blood sugar control in people with Type 1 diabetes (T1D). The study aims to understand the connection between perceived stress and glucose levels by using a special app called a "stressometer." This app allows participants to rate their stress on a scale from 0 to 10, four times a day, while avoiding mealtimes to prevent any influence from food on blood sugar. The trial will include 125 participants at 14 different centers in France, all of whom will be using insulin pumps or multiple daily injections.

To be eligible for the study, participants need to be at least 18 years old and diagnosed with Type 1 diabetes for at least a year. They should have a compatible smartphone and have been using an insulin pump or injections for at least two months. Participants will also need to agree to wear a watch and, in some cases, a ring that collects data throughout the study. It's important to note that certain conditions and medications may exclude individuals from participating, and all participants must be part of the French Social Security system. This study is not yet recruiting, but it aims to provide valuable insights into how stress impacts diabetes management.

Gender

ALL

Eligibility criteria

• 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.