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CompletedNCT05831384DDSUpdated Aug 28, 2023

Does Diabetes Related Distress Impact on Balance Glycemic ?

An observational study in Diabetes, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-28.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
66
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diabetes

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Keywords

  • Diabetes
  • Distress
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 66 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All adult hospitalized patients for diabetes at IE3M.

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

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).
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: at baseline

07

Study locations

1 site
  • Diabetology department - Hospital of Pitié Salpêtrière - APHP
    Paris, 75013, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05831384
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Apr 26, 2023
Start date
May 11, 2023
Primary completion
May 30, 2023
Completion
May 30, 2023
Last update
Aug 28, 2023

Study contacts

Evelyne Alvitre, Nursing degree
principal investigator · Diabetology department - Hospital of Pitié Salpêtrière

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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