Evaluating the link between depression and blood sugar control in type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational pilot study aims to explore the relationship between glycemic control and depression in individuals with type 1 diabetes. Participants will attend a single visit where they will provide informed consent and complete various questionnaires assessing their mental health and treatment satisfaction. The study will gather data on diabetes history, medications, and continuous glucose monitoring metrics to evaluate the potential association between depression scores and time spent in the optimal glycemic range.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Informed consent before any activity foreseen by the protocol
2. Age \> 18 years
3. Subjects with type 1 diabetes mellitus, both on multiple daily injection and with insulin pump, using glucose monitoring systems, both flash glucose monitoring and continuous glucose monitoring

Exclusion criteria:

1. Type 2 diabetes mellitus or other forms of diabetes, such as steroid-induced or secondary to pancreatectomy, pancreatitis, or secondary to endocrinological disorders
2. Previous diagnosis of major depression, bipolar disorder, psychotic disorder, eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder)
3. Chronic treatment with corticosteroids
4. BMI \<19kg/m2
5. Known history of substance or alcohol abuse
6. Patients who have recently been admitted to the psychiatry ward or are being treated with psycho-drugs
7. Conditions that do not allow participation in the activities envisaged by the protocol

Where it's running

• Università Cattolica del Sacro Cuore
  Roma, Italy Recruiting

Study contacts

• Principal investigator: Dario Pitocco — Fondazione Policlinico Universitario A. Gemelli, IRCCS
• Study coordinator: Dario Pitocco
• Email: dario.pitocco@policlinicogemelli.it
• Phone: +390630154071

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.