Remission Through Early Monitored Insulin Therapy - Duration Month

Remission Through Early Monitored Insulin Therapy - Duration Month

REMIT-DM is a feasibility pilot study where participants will be recruited soon after their diagnosis of type 2 diabetes to be placed immediately on insulin therapy for maximum of four weeks with titrations of insulin guided by glucose levels and trends provided by a continuous glucose monitor (CGM), with the purpose of achieving diabetes remission.

REMIT-DM is a feasibility pilot study that aims to show that previously published diabetes remission through early use and titration of short-term insulin therapy is possible and safe in the ambulatory diverse American population of patients with T2D, with continuous glucose level and trend information provided by CGM. We developed the algorithm based on published diabetes remission studies and include within the algorithm the CGM trend arrows to further refine insulin doses for both safety and efficacy purposes. Data captured by the CGM transmits automatically to the cloud and is accessible at any time of day by the multidisciplinary diabetes team, which includes the certified diabetes educator (CDE) and Endocrinologist. The CGM-guided insulin titration algorithm is designed to achieve euglycemia (defined as fasting CBG < 100 mg/dL, and 2 hour post-prandial CBG < 120 mg/dL) within 2 weeks of initiating insulin therapy, then to help maintain euglycemia for 2 weeks before discontinuing insulin entirely. Ten participants will undergo a maximum of 4 weeks of insulin therapy and will be assessed for remission afterwards to confirm enough recovery of beta cell function. (Complete remission is defined as fasting glycemia <100 mg/dL without use of pharmacological therapy.) Afterwards, we will implement American Diabetes Association (ADA) guidelines for standard glycemic management, as necessary. We will use the data collected during this feasibility study to sharpen the CGM-guided insulin titration algorithm for creation of a T2DM remission mobile application that could then be tested and studied in a larger sample size.

The feasibility study will also take into account clinically meaningful data points e.g. the number of phone calls between the patient and the diabetes team, the patient experience, and patient satisfaction.

Inclusion Criteria:

1. Age ≥18
2. A1C criteria - >7.0
3. Newly diagnosed with T2D within 4 years
4. Lifestyle controlled
5. Subject may be on up to 2 medications for diabetes.
6. Smart phone or home computer compatible with DEXCOM CLARITY software
7. English speaking
8. Assessed by endocrinologist and diabetes educator to be able to perform skills necessary for CGM use and insulin delivery

Exclusion Criteria:

1. Autoimmune Type 1 DM, defined as positive GAD65 or islet cell antibodies
2. Pregnant
3. Chronic Kidney Disease (CKD) Stage IV or greater
4. Mental and/or cognitive disorder (based on documented disorder and/or assessment of physician or educator)
5. No access to computer for downloading CGM
6. BMI <18.0