NCT05048264

Brief Summary

The purpose of this study is to measure the effect of various corticosteroids administered to the shoulder, knee and hip joints in diabetic patients on resultant blood glucose readings.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
terminated

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

September 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 4, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2024

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

September 8, 2021

Last Update Submit

March 21, 2025

Conditions

Diabetes MellitusSteroid DiabetesShoulder OsteoarthritisKnee OsteoarthritisAdhesive CapsulitisHip Osteoarthritis

Keywords

DiabetesCorticosteroidsInjectionShoulderPainOsteoarthritisKneeHip

Outcome Measures

Primary Outcomes (1)

  • Change in blood glucose measures

    Reported daily glucose measures from baseline to two week after injection

    Baseline & 2 weeks

Study Arms (1)

Diabetic patients receiving a corticosteroid injection of their shoulder, knee or hip joints.

There are no study-related interventions for this study.

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who has been clinically diagnosed with diabetes and receiving a corticosteroid injection in their shoulder, knee or hip joints.

You may qualify if:

  • Known diabetic patients ages 40-75 undergoing clinically indicated standard of care corticosteroid shoulder, knee and hip joint injection
  • Ability to perform daily blood glucose testing
  • Can receive and send text messages

You may not qualify if:

  • Previous joint arthroplasty
  • Corticosteroid injection at other sites in the body within the past month
  • Systemic corticosteroid within the last month other than asthma inhaler
  • Anyone who are unable to read and/or understand English
  • Pregnant women (self-report)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Sports Science Institute

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Diabetes MellitusOsteoarthritis, KneeBursitisOsteoarthritis, HipPainOsteoarthritis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anthony Ceraulo, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 17, 2021

Study Start

May 4, 2023

Primary Completion

September 12, 2024

Study Completion

September 16, 2024

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)