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Personalized Diabetes Medication Adjustment for Type 2 Diabetes (CHANGE Trial)
CHANGE Trial Summary
This trial is aimed to show that adjusting the drugs to keep glucose levels normal, can help to preserve β-cell function compared to usual diabetes care, possibly reduce the tendency to develop the eye and kidney complications of diabetes, and might also be more cost-effective than usual care.
CHANGE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCHANGE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CHANGE Trial Design
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Who is running the clinical trial?
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- I have pancreatitis.I have a family or personal history of MEN2A.I am currently taking steroid medications.Your blood sugar level after drinking a sugary drink is higher than 155 mg/dl.Your ALT level is more than 3 times the normal range.I am between 40 and 74 years old.I have been diagnosed with dementia.I have had weight loss surgery.I had a cardiovascular event in the last year.You have been diagnosed with diabetes through an oral glucose tolerance test (OGTT).My kidney function is reduced with an eGFR of 50 ml/min or less.Your HbA1c levels are between 6.0% and 7.4%.You have a body mass index (BMI) higher than 40.You are not expected to live for at least 5 more years.I experience severe chest pain frequently.My heart condition is in an advanced stage.
- Group 1: USE OF DIABETES Rx GUIDED LARGELY BY HbA1c LEVELS
- Group 2: USE OF DIABETES Rx GUIDED BY SELF-MONITORED BLOOD GLUCOSE (SMBG)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there still availability for enrolment in this clinical research?
"This clinical trial is actively enrolling participants, as reported on the website of clinicialtrials.gov. The first posting was on September 1st 2021 and it has been updated most recently on February 14th 2022."
Can persons over the age of 45 partake in this investigation?
"This medical research is currently welcoming participants aged between 40 and 74 years."
What is the maximum capacity of participants for this clinical trial?
"Affirmative. According to the data featured on clinicaltrials.gov, this trial is actively enlisting participants; it was initially posted in September 2021 and recently updated in February 2022. 126 individuals are sought at 1 centre for participation."
Is it possible for me to take part in this research endeavor?
"This trial seeks to recruit 126 participants between the ages of 40 and 74 that have been diagnosed with Type 2 diabetes Mellitus."
What are the expected results from this research?
"The overarching purpose of this multi-year medical trial (which involves a 3 month washout period) is to evaluate β-cell function as the primary outcome. Secondary objectives encompass point of care glucose analysis through continuous glucose monitoring, an examination of the need for medications based on ROC areas and Youden indices, prediction of initial vs. later medication requirement independent from disease prevalence, nephropathy evaluation via urine microalbumin/creatinine ratio tests every 6 months up until 2.5 years, and cost effectivity should supplementary funding be allocated."
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