RecruitingNot ApplicableNCT06896045

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


Sponsor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Enrollment

125 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Type 1 diabetes (T1D) affects around 200,000 people in France. The only treatment is insulin, administered either by multiple injections, by pump alone or, more recently, by automated insulin delivery systems (AIDs), which have resulted in a very significant improvement in glycaemic control and quality of life. These closed-loop (CL) devices are capable of effectively regulating the conventional factors associated with glycaemic disturbance, namely dietary intake and physical activity. However, they do not account of stress, which some subjects with T1D perceive as a major disrupter of their blood sugar levels. One of the reasons for this is undoubtedly that stress, unlike diet or physical activity, cannot be anticipated. Since stress is difficult to predict, it is also more difficult to study. Its onset, intensity, duration and progression are linked to the subject's experience, psychological state and environment. Not all patients respond to stress triggers in the same way. Some patients appear to be more reactive than others to these agents, particularly when they are exposed to them chronically or repeatedly, in an anxiety-provoking environment. This is known as chronic psychosocial stress, and it is this type of stress that seems to be most closely associated with glycaemic disturbance in subjects with T1D, most often in the form of hyperglycaemia and, more rarely, hypoglycaemia. However, there are no solid epidemiological or experimental data to support these observations. The study we propose is a prospective multicentre clinical trial in 125 subjects with T1D treated with insulin pumps or multi-injections at 14 French university centres. Our aim is to evaluate the relationship between interstitial glucose levels measured by CGM and perceived stress, assessed 4 times a day, away from mealtimes in order to avoid the impact of dietary glycaemia, using a "stressometer". This stressometer is an application designed by CERITD that can be downloaded to the patient's smartphone and consists of an electronic visual analogue scale (VAS) on which the level of stress felt is evaluated quantitatively (continuous value between 0 and 10).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring the relationship between daily stress and blood sugar levels in people with type 1 diabetes who use an insulin pump or multiple daily injections. Researchers want to understand how emotional stress and mental pressure affect glucose control, so that better management strategies can be developed. Participants will use a smartphone app to log their stress levels alongside continuous glucose monitoring data. **You may be eligible if...** - You are 18 years or older with a confirmed diagnosis of type 1 diabetes for at least 1 year - You use an insulin pump (for at least 2 months) or take multiple daily insulin injections - You have a compatible smartphone (iOS 15.0+ or Android 12.0+) with Bluetooth 5.0 - You use a compatible continuous glucose monitor (CGM) **You may NOT be eligible if...** - You do not have a compatible smartphone or CGM device - You have a serious condition that would prevent you from participating in the study activities - You are pregnant - You do not consent to sharing your glucose and stress data Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAssess stress levels 4 times a day before meals (morning, noon and evening and at bedtime) using a visual analogue scale

In addition to stress assessment with the stress meter, patients will be fitted with a Continious Glucose Monitoring


Locations(14)

Angers University Hospital

Angers, France

Avignon Hospital

Avignon, France

Bordeaux University Hospital

Bordeaux, France

Brest University Hospital

Brest, France

Dijon University Hospital

Dijon, France

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

Évry, France

Grenoble University Hospital

Grenoble, France

St Louis Hospital

La Rochelle, France

Lille University Hospital

Lille, France

DiabeCare diabetes centre

Lyon, France

European Hospital

Marseille, France

Private practice in endocrinology and metabolic diseases

Mérignac, France

Rennes University Hospital

Rennes, France

Strasbourg University Hospital

Strasbourg, France

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NCT06896045


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