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Does Diabetes Related Distress Impact on Balance Glycemic ?

Does Diabetes Related Distress Impact on Balance Glycemic ?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05831384
Acronym
DDS
Enrollment
66
Registered
2023-04-26
Start date
2023-05-11
Completion date
2023-05-30
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, Distress

Brief 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.

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Overall diabetes distress scoreat baselineThe 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.

Secondary

MeasureTime frameDescription
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)at baselineThe patient's glycated haemoglobin (Hba1c) result, expressed as a %, taken during the standard check-up on the day of admission to hospital.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026