Changing the Natural History of Type 2 Diabetes ("CHANGE" Study)

What this study is testing ClinicalTrials.gov NCT05040087 ↗

Description as written by the study sponsor.

Diabetes is a disorder of high blood glucose, that tends to get worse; over time, patients need more and more drugs. This pattern is caused by overwork of the body's insulin-producing β-cells, because patients' glucose levels are typically above normal; if the investigators kept glucose levels normal - reducing β-cell work - the investigators might be able to keep the disease from getting worse. 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.

Treatments tested

• Intensification of diabetes medication based largely on HbA1c levels Other

  Use of diabetes Rx in controls will be guided largely by HbA1c levels.

• Intensification of diabetes medication based on glucose levels Other

  Use of diabetes Rx in the intensive Rx groups will be guided by participants' self-monitored blood glucose levels (SMBG), with management aimed to keep glucose levels within the normal range.