Remission Through Early Monitored Insulin Therapy - Duration Month

NCT03670641 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: PRO17110070
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Insulin therapy; Continuous glucose monitor

Outcome Measures

Primary Outcomes (1)

• Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months

  Blood test drawn at baseline and after insulin and CGM-guided titration intervention at 3 month intervals to see if improvement in aggregate A1C value is achieved.

  Every 3 months up to 1 year

Secondary Outcomes (5)

• Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention

  A1C measures every 3 months up to 1 year

• Number of Patients With Glucose Values <55 mg/dL During 4 Week of Insulin and CGM Intervention

  4 weeks

• See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale

  1 year

• Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention

  4 weeks

• Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period

  4 weeks

Study Arms (1)

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.

Drug: Glargine; Drug: Lispro; Device: Dexcom G6

Interventions

Glargine DRUG

Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.

Also known as: Lantus

Insulin and CGM Intervention

Lispro DRUG

Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.

Also known as: Humalog

Insulin and CGM Intervention

Dexcom G6 DEVICE

Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.

Also known as: CGM

Insulin and CGM Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• A1C criteria - \>7.0
• Newly 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sandra Sobel: lead

Study Sites (1)

UPMC Falk Diabetes Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Limitations and Caveats

Statistical analyses beyond those reported here were not conducted due to low number of participants enrolled

Results Point of Contact

• Title: David Rometo, MD
• Organization: University of Pittsburgh Medical Center (UPMC)

rometoda@upmc.edu

412-586-9700

Study Officials

• Sandra I Sobel, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• David A Rometo, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Linda Siminerio, RN PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Shari Reynolds

  University of Pittsburgh

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 13, 2018
• Study Start: March 26, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-09

Locations

US (1)