Evaluating the link between depression and blood sugar control in type 1 diabetes
Evaluation of the Association Between Depression and Glycemic Control in People With Type 1 Diabetes
This study is trying to see if there's a connection between blood sugar control and depression in people with type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT05950477 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with type 1 diabetes who use glucose monitoring systems.
Not a fit: Patients with type 2 diabetes or other forms of diabetes, as well as those with a history of major depression or other specified psychiatric disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how depression affects glycemic control, potentially leading to improved management strategies for patients with type 1 diabetes.
How similar studies have performed: While the association between mental health and diabetes management has been explored in other studies, this specific approach focusing on glycemic control in type 1 diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Roma
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.