Remission Through Early Monitored Insulin Therapy - Duration Month

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine and Insulin Lispro.

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.

It had 1 arm (groups): Insulin and CGM Intervention (experimental).

10 individuals with newly diagnosed type 2 diabetes will be started on basal (glargine) bolus (lispro) insulin therapy for up to 4 weeks with titrations guided by continuous glucose monitor (Dexcom G6) to achieve euglycemia and then insulin stopped after 4 weeks with hopes of diabetes remission.

The registry classes the interventions as device and drug.

More on the Plan

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.

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.

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.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: A1C criteria - \>7.0. Newly diagnosed with T2D within 4 years. Subject may be on up to 2 medications for diabetes. Smart phone or home computer compatible with DEXCOM CLARITY software. Assessed by endocrinologist and diabetes educator to be able to perform skills necessary for CGM use and insulin delivery.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: autoimmune type 1 dm, defined as positive gad65 or islet cell antibodies; chronic kidney disease (ckd) stage iv or greater; mental and/or cognitive disorder (based on documented disorder and/or assessment of physician or educator).

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Insulin Glargine study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-03-26 with completion listed for 2020-07-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months (time frame: Every 3 months up to 1 year).

It also tracked 5 secondary outcomes, for example See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale, Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention and Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine and Insulin Lispro in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page and the Insulin Lispro compound page, all human trials.