Remission Through Early Monitored Insulin Therapy - Duration Month
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sandra Sobel

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Study Protocol  
 
 
 
 
 
 
Official Title: Remission through Early Monitored Insulin Therapy 
- Duration Month (REMIT-DM) 
  
 
 
ClinicalTrials.gov ID (NCT number): NCT03670641 
 
 
 
Protocol Date: 06 July 2021 
 
 
 
 

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Scientific Background 
 
REMIT-DM is a feasibility 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 subjects 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. 
Study Objectives 
 
 
 

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Study Design & Methods 
 
Participants will be assessed by the endocrinologist and diabetes 
educator to be able to perform skills necessary for CGM use and insulin 
delivery. If the CDE determines that the patient is unable or unwilling to 
perform the necessary care tasks, this will be communicated to the 
endocrinologist for potential exclusion from the study. 
 
The Research Activities: 
 
-Study Visit 1: The PAID-5 survey will be administered to assess 
diabetes distress by the RN CDE prior to the diabetes education session. 
Subject will undergo standard of care diabetes self-management 
education by the study team members, including the initiation of the 
CGM. OGTT lab blood draw will be done. 
 
-Study Visit 2: Subject will undergo standard of care education for 
insulin start. Research activity: study team will provide the insulins and 
instruct the subject in the insulin titration protocol and how CGM 
readings will be used to manage insulin doses. Subject will adjust their 
meal-time insulin doses by the before meal blood sugar and the CGM 
predictive arrows and their daily basal insulin based on how close 
fasting glucose was to glucose target. Study team will confirm that 
subject understands how the study works using the teach-back method. 
Ample time for question and answer will be allotted. 
 
-Study Visit 3: The PAID-5 will be administered at this visit as well as 
the satisfaction survey. These will both be administered by the RN CDE 
prior to the education session. If remission is achieved, patient will turn 
in their CGM and go off their insulin. A repeat OGTT lab blood draw 
will be done at this time as well. If remission is not achieved, the 
standard ADA algorithm would apply and patient would be placed back 
on their medication(s). However, there may be some patients that would 
prefer to stay on insulin or for which remaining on insulin therapy is 

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appropriate. The patient will be started on appropriate therapy as guided 
by clinical decision making. 
 
-Study Visits 4-6: post 4 weeks-1 year patient will have standard of care 
endocrinology visits driven by clinical decision making. 
 
-Study Visit 7: At 12 months, the PAID-5 and satisfaction survey will 
again be administered by the RN CDE. 
 
Algorithm Development/Data Analysis Period: 
 
-Post 12 month intervention period: Algorithm and Protocol 
development 
 
All program data, e.g. number of calls, length of calls, information 
reviewed/requested on call, documentation of extraneous calls, e.g. after 
hours/outside of schedule. Clinical outcomes, e.g. rates of 
hypoglycemia, laboratory results will be analyzed and reviewed. Based 
on the findings a full protocol that includes the finalized insulin titration 
algorithm and program processes will be prepared. 
 
Eligibility Criteria 
 
Inclusion criteria: 
• Age ≥18 
• A1C criteria - >7.0 
• Diagnosed with T2D within 4 years 
• Lifestyle controlled 
• Subject may be on up to 2 medications for diabetes. 
• Smart phone or home computer compatible with DEXCOM 
CLARITY software 
• English speaking 
• Assessed by endocrinologist and diabetes educator to be able to 
perform skills necessary for CGM use and insulin delivery 

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Exclusion criteria: 
• Autoimmune Type 1 DM, defined as positive GAD65 or islet cell 
antibodies 
• Pregnant 
• Chronic Kidney Disease (CKD) Stage IV or greater 
• Mental and/or cognitive disorder (based on documented disorder 
and/or assessment of physician or educator) 
• No access to computer for downloading CGM 
• BMI <18.0 
 
Statistical Considerations 
 
This is a feasibility study that does not require power calculation. 
 
Baseline characteristics will be described using measures of central 
tendencies (means, median, standard deviations). To examine time to 
glucose target range, hypo/and hyperglycemia, logistic regression will 
be used. Covariates in the models will include demographic factors, 
glucose dosing information, insulin protocol used.