Prevalence of Musculoskeletal Disorders of Upper Limb in Type 1 Diabetes Patients (TMS-DT1)

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Data collection

Detailed Description

The aim of the study is to describe prevalence of musculoskeletal disorders of upper limb in type 1 diabetes patients.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Brigitte DELEMER, MD; Phone Number: +33 0326788101; Email: bdelemer@chu-reims.fr

Study Locations

• France
  • Grand-Est
    • Reims, Grand-Est, France, 51100
      • Recruiting
      • Centre Hospitalier Universitaire de Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with type 1 diabetes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
type 1 diabetes; "type 1 diabetes" group: patients with type 1 diabetes	Other: Data collection; Description: musculoskeletal disorders of upper limb evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Université de Reims Champagne-Ardenne

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: prevalence; musculoskeletal disorders
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Musculoskeletal Diseases
• Other Study ID Numbers: 2021-013-TMS-DT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No