Clinical trial NCT03670641: Remission Through Early Monitored Insulin Therapy - Duration Month
Official title: Remission Through Early Monitored Insulin Therapy - Duration Month
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Insulin therapy
Continuous glucose monitor
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 10 participants will be recruited soon after diagnosis of type 2 diabetes and started on short term insulin therapy to achieve euglycemia with insulin doses guided by continuous glucose monitor algorithm
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months
timeFrame: Every 3 months up to 1 year
Secondary outcomes:
measure: Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention
timeFrame: A1C measures every 3 months up to 1 year
measure: Number of Patients With Glucose Values <55 mg/dL During 4 Week of Insulin and CGM Intervention
timeFrame: 4 weeks
measure: See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale
timeFrame: 1 year
measure: Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention
timeFrame: 4 weeks
measure: Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Falk Diabetes Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sandra I Sobel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: David A Rometo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Linda Siminerio, RN PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Shari Reynolds
role: STUDY_CHAIR
References: