Subject: Evaluation of Glycosylated Hemoglobin in Indian diabetics on combination Therapy – A multicenter, retrospective, cross-sectional study (TIGHT-IV Study)
Diabetes affects more than 537 million individuals across the globe and is one of the leading causes of death worldwide. India, the largest country in the region, is also the largest contributor to the NCD burden. Several studies conducted over the last two decades have revealed the high total burden of diabetes, hypertension, and dyslipidemia in India. International Diabetes Federation (IDF 2021) has estimated that India currently has around 74 million people with type 2 diabetes mellitus (T2DM) and the numbers are poised to increase to 125 million in the next 20 years. 2022 American Association of Clinical Endocrinologists (AACE) clinical practice guidelines, the current glycemic algorithm is a patient-centered, step-up approach with individualized medical nutrition therapy and individualized DM therapy based on the level of glycemia and present comorbidities. While metformin remains a commonly prescribed initial therapy, it is no longer considered the only acceptable first-line agent. If the patient has established or high cardiovascular risk, heart failure, or chronic kidney disease, then GLP-1RAs or SGLT-2is are recommended. If HbA1c levels remain >7.5%, then a dual-therapy combination is recommended, and if no improvement is seen in 3 months, then a triple-therapy combination is recommended. Injectable therapy should be considered if the initial HbA1c levels are >9.0%, starting with a GLP-1RA followed by insulin treatment. Drug combination therapy has emerged as a comprehensive treatment approach for diabetes. An increasing number of studies have shown that, compared with monotherapy, combination therapy can bring significant clinical benefits while controlling blood glucose, weight, and blood pressure, as well as mitigating damage from certain complications and delaying their progression in diabetes.
This retrospective, cross-sectional multicenter study is planned to evaluate the glycemic control in type 2 diabetes patients on combination therapy and current management practices of T2DM patients in India.
We invite you to participate in this study. On acceptance, you will need to capture the relevant data as mentioned in the standard Data Collection Form (DCF) provided, from the patient’s medical records (case papers and investigational reports – hereafter referred as source documents).
We would recommend you to capture data fulfilling the criteria as outlined in the protocol and whose relevant laboratory investigations are available for the preceding 3 months.
We wish to inform you that the DCF will capture all data in de-identified form and any identifiable parameters which may potentially disclose the identity of the patient such as name or address will strictly not be captured so as to ensure we maintain patient confidentiality. We would encourage you to carefully fill all available information to the fullest as recommended in the DCF.
In alignment with good clinical research practices, an independent CRO will monitor this study and do the source data verification of the data captured in the DCF with copies of the patients’ source medical records (case papers and investigational reports) to ensure that the data entered in the DCFs are accurate and in alignment with the patients’ medical records.
If you agree to participate in the said study, we would request you to sign and return the enclosed reply along with your visiting card for accuracy of records.
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