Type 1 DiabetesNCT05950477
Evaluation of the Association Between Depression and Glycemic Control in People With Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Single-center prospective observational pilot study The aim of the study is to evaluate the potential association between the percentage of time spent in the optimal glycemia range and the score obtained in the questionnaires used to screen for depression. The study involves only one visit for each participant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Depression Questionnaires
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 diabetic patients at risk of developing a mood disorders and who meet the inclusion criteria will be enrolled. It is estimated that it is necessary to enroll 100 subjects in order to identify an expected correlation coefficient equal to 0.30, with a power of 85% and a probability value α (two-tailed) of 0.05.
Who may be able to join
- Informed consent before any activity foreseen by the protocol
- Age > 18 years
- 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
Who cannot join
- Type 2 diabetes mellitus or other forms of diabetes, such as steroid-induced or secondary to pancreatectomy, pancreatitis, or secondary to endocrinological disorders
- Previous diagnosis of major depression, bipolar disorder, psychotic disorder, eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder)
- Chronic treatment with corticosteroids
- BMI <19kg/m2
- Known history of substance or alcohol abuse
- Patients who have recently been admitted to the psychiatry ward or are being treated with psycho-drugs
- Conditions that do not allow participation in the activities envisaged by the protocol
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Università Cattolica del Sacro Cuore
Roma, 00168
Dario Pitocco, +390630154071, dario.pitocco@policlinicogemelli.it
About this study
Single-center prospective observational pilot study
The aim of the study is to evaluate the potential association between the percentage of time spent in the optimal glycemia range and the score obtained in the questionnaires used to screen for depression.
Read more
The study involves only one visit for each participant. Each participant will be asked to sign the informed consent to the study and, during the visit, the following information will be acquired: parameters, history of diabetes, concomitant diseases and medications, and CGM metrics.
The participant will be administered the following questionnaires for the evaluation of depression, patient-reported outcome measure (PROMs) and treatment satisfaction:
- Patient Health Questionnaire (PHQ-9)
- Center of Epidemiological Studies-Depression Scale (CES-D)
- Diabetes Treatment Satisfaction Questionnaire (DTSQ)
- Well-Being Index (WHO-5)
- Problem Areas In Diabetes (PAID-5)
- European Quality of Life, Five Dimension, Five Level (EQ5D5L)
- Conditions
- Type 1 Diabetes
- Being tested
- Depression Questionnaires
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depression QuestionnairesDiagnostic test
Center of Epidemiological Studies-Depression Scale (CES-D) Patient Health Questionnaire (PHQ-9) Diabetes Treatment Satisfaction Questionnaire (DTSQ) Well-Being Index (WHO-5)
What is being measured
The primary outcome is the main question the study is designed to answer.
In 100 subjects with type 1 diabetes it will be evaluated the relationship between time in range, assessed though continuous glucose monitoring, and the score of the depression questionnaire CES-D
Evaluation of the relationship between time in optimal glycemic range (70-180 mg/dl) and scores at depression questionnaire
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start12 Jun 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dario Pitocco, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950477
- Sponsor's protocol ID
- 5733
- Status last verified
- Jun 2023
- First submitted
- 10 Jul 2023
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between Depression and Glycemic Control in People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05950477
- Acronym / sponsor ID
- 5733
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-center prospective observational pilot study
The aim of the study is to evaluate the potential association between the percentage of time spent in the optimal glycemia range and the score obtained in the questionnaires used to screen for depression.
The study involves only one visit for each participant. Each participant will be asked to sign the informed consent to the study and, during the visit, the following information will be acquired: parameters, history of diabetes, concomitant diseases and medications, and CGM metrics.
The participant will be administered the following questionnaires for the evaluation of depression, patient-reported outcome measure (PROMs) and treatment satisfaction:
- Patient Health Questionnaire (PHQ-9)
- Center of Epidemiological Studies-Depression Scale (CES-D)
- Diabetes Treatment Satisfaction Questionnaire (DTSQ)
- Well-Being Index (WHO-5)
- Problem Areas In Diabetes (PAID-5)
- European Quality of Life, Five Dimension, Five Level (EQ5D5L)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 diabetic patients at risk of developing a mood disorders and who meet the inclusion criteria will be enrolled. It is estimated that it is necessary to enroll 100 subjects in order to identify an expected correlation coefficient equal to 0.30, with a power of 85% and a probability value α (two-tailed) of 0.05.
Key inclusion criteria (3 listed)
- Informed consent before any activity foreseen by the protocol
- Age > 18 years
- 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
Key exclusion criteria (7 listed)
- Type 2 diabetes mellitus or other forms of diabetes, such as steroid-induced or secondary to pancreatectomy, pancreatitis, or secondary to endocrinological disorders
- Previous diagnosis of major depression, bipolar disorder, psychotic disorder, eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder)
- Chronic treatment with corticosteroids
- BMI <19kg/m2
- Known history of substance or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depression QuestionnairesCenter of Epidemiological Studies-Depression Scale (CES-D) Patient Health Questionnaire (PHQ-9) Diabetes Treatment Satisfaction Questionnaire (DTSQ) Well-Being Index (WHO-5) | Diagnostic test | – |
Primary outcome
In 100 subjects with type 1 diabetes it will be evaluated the relationship between time in range, assessed though continuous glucose monitoring, and the score of the depression questionnaire CES-D
Time frame: 14 days
Evaluation of the relationship between time in optimal glycemic range (70-180 mg/dl) and scores at depression questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dario Pitocco principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dario Pitocco (+390630154071, dario.pitocco@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In 100 subjects with type 1 diabetes it will be evaluated the relationship between time in range, assessed though continuous glucose monitoring, and the score of the depression questionnaire CES-D (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.