Diabetes MellitusCSINCT05048264
Effect of Corticosteroid Injections on Blood Glucose
An observational study of Diabetes Mellitus and Steroid Diabetes, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Steroid Diabetes, Shoulder Osteoarthritis
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to 16 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who has been clinically diagnosed with diabetes and receiving a corticosteroid injection in their shoulder, knee or hip joints.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Sports Science Institute
Durham, North Carolina, 27705
About this study
Official title: Corticosteroid Injections Administered Under Ultrasound Guidance to Diabetic Patients and the Effect on Blood Glucose
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.
Read the detailed description
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.
Corticosteroid injections (CSI) are frequently used in orthopedic settings in order to treat a wide array of orthopedic issues, including osteoarthritis, bursitis, tendinitis, and many others. The effect of diabetes on the musculoskeletal system and its role in orthopedic disease has been well-documented. Current evidence demonstrates that corticosteroids, even when administered through a local musculoskeletal injection, can lead to temporary increases in blood glucose. Ultrasound guidance was not explicitly used in any of the studies examining the impact of steroids on blood glucose. The utilization of ultrasound guidance has been shown to increase accuracy when performing injections into the subacromial space as well as the glenohumeral joint when compared to palpation/landmark-guided injections.
- Conditions
- Diabetes Mellitus, Steroid Diabetes, Shoulder Osteoarthritis, Knee Osteoarthritis, Adhesive Capsulitis, Hip Osteoarthritis
- Keywords
- Diabetes, Corticosteroids, Injection, Shoulder, Pain, Osteoarthritis, Knee, Hip
- Medical subject headings
- Diabetes Mellitus, Osteoarthritis, Knee, Bursitis, Osteoarthritis, Hip, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients receiving a corticosteroid injection of their shoulder, knee or hip joints. | There are no study-related interventions for this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose measures
Reported daily glucose measures from baseline to two week after injection
Measured: Baseline & 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start4 May 2023
- Primary completion12 Sep 2024
- Study completion16 Sep 2024
Why it stopped: Study terminated due to needed protocol restructuring for study aim expansion and changes to data collection methodology and software model use.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Ceraulo, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048264
- Sponsor's protocol ID
- Pro00108093
- Acronym
- CSI
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2021
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Injections Administered Under Ultrasound Guidance to Diabetic Patients and the Effect on Blood Glucose
- ClinicalTrials.gov ID
- NCT05048264
- Acronym / sponsor ID
- CSI / Pro00108093
- Conditions
- Diabetes Mellitus, Steroid Diabetes, Shoulder Osteoarthritis, Knee Osteoarthritis, Adhesive Capsulitis, Hip Osteoarthritis
- Keywords
- Diabetes, Corticosteroids, Injection, Shoulder, Pain, Osteoarthritis, Knee, Hip
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated due to needed protocol restructuring for study aim expansion and changes to data collection methodology and software model use.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Corticosteroid injections (CSI) are frequently used in orthopedic settings in order to treat a wide array of orthopedic issues, including osteoarthritis, bursitis, tendinitis, and many others. The effect of diabetes on the musculoskeletal system and its role in orthopedic disease has been well-documented. Current evidence demonstrates that corticosteroids, even when administered through a local musculoskeletal injection, can lead to temporary increases in blood glucose. Ultrasound guidance was not explicitly used in any of the studies examining the impact of steroids on blood glucose. The utilization of ultrasound guidance has been shown to increase accuracy when performing injections into the subacromial space as well as the glenohumeral joint when compared to palpation/landmark-guided injections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients receiving a corticosteroid injection of their shoulder, knee or hip joints. | – | –There are no study-related interventions for this study. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who has been clinically diagnosed with diabetes and receiving a corticosteroid injection in their shoulder, knee or hip joints.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in blood glucose measures
Time frame: Baseline & 2 weeks
Reported daily glucose measures from baseline to two week after injection
Results and safety
The study was stopped early (reason given: Study terminated due to needed protocol restructuring for study aim expansion and changes to data collection methodology and software model use.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Ceraulo, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Steroid Diabetes, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to needed protocol restructuring for study aim expansion and changes to data collection methodology and software model use.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood glucose measures (time frame: Baseline & 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.