DiabetesDDSNCT05831384
Does Diabetes Related Distress Impact on Balance Glycemic ?
An observational study of Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective is to assess the overall diabetes distress score in adult patients with diabetes during their hospitalization in a diabetes ward, using the Diabetes Distress Scale (DDS-17). The correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin will then be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2023to 30 May 2023
- 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: All adult hospitalized patients for diabetes at IE3M.
Who may be able to join
- Patients living with type 1 or type 2 diabetes.
- Patients hospitalised in the diabetes department of the IE3M.
- Patients aged ⩾ 18 years.
- Patients agreeing to participate in this study after information.
- Beneficiary of the health insurance.
Who cannot join
- Refusal to participate.
- Inability to communicate in French.
- Inability to read or write French.
- Communication disorders.
- History of psychiatric disorders, dementia.
- Patient under guardianship or curatorship.
- Patient not affiliated to social security.
- Patient affiliated to the Aide Médicale d'Etat (AME).
Trial locations and contacts
1 site in 1 country.
France1 site
Diabetology department - Hospital of Pitié Salpêtrière - APHP
Paris, 75013
About this study
The main objective is to assess the overall diabetes distress score in adult patients with diabetes during their hospitalization in a diabetes ward, using the Diabetes Distress Scale (DDS-17).
The correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin will then be assessed.
Read the detailed description
The health consequences of emotional problems are associated with poor self-care behaviour, poor metabolic outcomes (HbA1c) and reduced quality of life. If quarterly glycated haemoglobin (HbA1c) testing is the gold standard for monitoring the risk of diabetes complications, should it not be systematically combined with the assessment of distress related to living with diabetes? To our knowledge, there are few studies in France that have correlated glycaemic control with a scale assessing the emotional stress factors associated with diabetes.
The main objective is to evaluate diabetes-related distress in adult patients with diabetes during their hospitalization in a diabetes ward, using a self-assessment instrument: the Diabetes Distress Scale (DDS-17).
The secondary objective is to assess the correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin.
- Conditions
- Diabetes
- Keywords
- Diabetes, Distress
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall diabetes distress score
The primary endpoint is the overall diabetes distress score obtained by the DDS-17 psychometric tool. Each item is rated on a 6-point scale ranging from (1) "not a problem" to (6) "a very significant problem".
Each of the 17 criteria of the DDS17 is rated on a 6-point scale ranging from (1) "not a problem" to (6) "a very important problem".
The scale gives an overall distress score based on the average responses on the 1-6 scale for the 17 items.
Interpretation of the DDS 17 total scores:
- Mean score < 2.0 = reflects little or no distress
- Mean score between 2.0 and 2.9 = reflects moderate distress
- Mean score > 3.0 = reflects high distress.
Measured: at baseline
Secondary outcomes (1)
The The patient's glycated haemoglobin (Hba1c) result, expressed as a %, taken during the standard check-up on the day of admission to hospital result (Hba1c)
The patient's glycated haemoglobin (Hba1c) result, expressed as a %, taken during the standard check-up on the day of admission to hospital.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start11 May 2023
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evelyne Alvitre, Nursing degree, Principal investigator, Diabetology department - Hospital of Pitié Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831384
- Sponsor's protocol ID
- APHP230419
- Other IDs
- 2023-A00342-43
- Acronym
- DDS
- Status last verified
- Aug 2023
- First submitted
- 14 Apr 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Diabetes Related Distress Impact on Balance Glycemic ?
- ClinicalTrials.gov ID
- NCT05831384
- Acronym / sponsor ID
- DDS / APHP230419
- Conditions
- Diabetes
- Keywords
- Diabetes, Distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 26 Apr 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.
The main objective is to assess the overall diabetes distress score in adult patients with diabetes during their hospitalization in a diabetes ward, using the Diabetes Distress Scale (DDS-17).
The correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin will then be assessed.
Detailed description
The health consequences of emotional problems are associated with poor self-care behaviour, poor metabolic outcomes (HbA1c) and reduced quality of life. If quarterly glycated haemoglobin (HbA1c) testing is the gold standard for monitoring the risk of diabetes complications, should it not be systematically combined with the assessment of distress related to living with diabetes? To our knowledge, there are few studies in France that have correlated glycaemic control with a scale assessing the emotional stress factors associated with diabetes.
The main objective is to evaluate diabetes-related distress in adult patients with diabetes during their hospitalization in a diabetes ward, using a self-assessment instrument: the Diabetes Distress Scale (DDS-17).
The secondary objective is to assess the correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult hospitalized patients for diabetes at IE3M.
Key inclusion criteria (5 listed)
- Patients living with type 1 or type 2 diabetes.
- Patients hospitalised in the diabetes department of the IE3M.
- Patients aged ⩾ 18 years.
- Patients agreeing to participate in this study after information.
- Beneficiary of the health insurance.
Key exclusion criteria (8 listed)
- Refusal to participate.
- Inability to communicate in French.
- Inability to read or write French.
- Communication disorders.
- History of psychiatric disorders, dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall diabetes distress score
Time frame: at baseline
The primary endpoint is the overall diabetes distress score obtained by the DDS-17 psychometric tool. Each item is rated on a 6-point scale ranging from (1) "not a problem" to (6) "a very significant problem". Each of the 17 criteria of the DDS17 is rated on a 6-point scale ranging from (1) "not a problem" to (6) "a very important problem". The scale gives an overall distress score based on the average responses on the 1-6 scale for the 17 items. Interpretation of the DDS 17 total scores: * Mean score < 2.0 = reflects little or no distress * Mean score between 2.0 and 2.9 = reflects moderate distress * Mean score > 3.0 = reflects high distress.
1 secondary outcome
The The patient's glycated haemoglobin (Hba1c) result, expressed as a %, taken during the standard check-up on the day of admission to hospital result (Hba1c)
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Evelyne Alvitre, Nursing degree principal investigator
Diabetology department - Hospital of Pitié Salpêtrière
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 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 28 Aug 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall diabetes distress score (time frame: at baseline). 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 28 Aug 2023.