NCT05164562

Brief Summary

Osteopenia and osteoporosis, particularly related to insulinopenia, are common in type 1 diabetes and increase the risk of fractures. Musculoskeletal disorders of the upper limb are a common complication of type 1 diabetes. However, there is no official recommendation for screening for musculoskeletal disorders in France.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

January 7, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

December 7, 2021

Last Update Submit

March 29, 2022

Conditions

Keywords

musculoskeletal disordersprevalence

Outcome Measures

Primary Outcomes (1)

  • musculoskeletal disorders of upper limb

    musculoskeletal disorders of upper limb evaluated using Quick Dash (Quick Disabilities of Arm, Shoulder and Hand). Quick Dash is a 11 items questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level. The score ranges from 0 (no disability) to 100 (most severe disability), a higher score indicates a greater level of disability and severity, whereas, lower score indicates a lower level of disability.

    Day 0

Study Arms (1)

type 1 diabetes

"type 1 diabetes" group: patients with type 1 diabetes

Other: Data collection

Interventions

Description: musculoskeletal disorders of upper limb evaluation

type 1 diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with type 1 diabetes

You may qualify if:

  • male or female
  • aged of 18 and more
  • with type 1 diabetes
  • agreeing to participate in the study

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Reims

Reims, Grand Est, 51100, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Musculoskeletal Diseases

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Brigitte DELEMER, MD

CONTACT

Coralie BARBE, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2021

First Posted

December 20, 2021

Study Start

January 7, 2022

Primary Completion

July 1, 2022

Study Completion

January 1, 2023

Last Updated

April 7, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations