Phase 4 N=10 Treatment

Remission Through Early Monitored Insulin Therapy - Duration Month

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT03670641 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months — 9.00; 6.81; 7.13; 7.26 percentage of glycosylated hemoglobin

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Glargine (Drug); Lispro (Drug); Dexcom G6 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sandra Sobel
Primary completion: Jul 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Baseline A1C and A1C Measured at 3 Month Intervals up to 12 Months	9.00; 6.81; 7.13; 7.26; 6.88	—
SECONDARY Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention	1; 2; 2; 4	—
SECONDARY Number of Patients With Glucose Values <55 mg/dL During 4 Week of Insulin and CGM Intervention	4	—
SECONDARY See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale	8.90; 7.62	—
SECONDARY Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention	46.3; 80.67	—
SECONDARY Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period	6; 8	—

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.

Eligibility Criteria

Inclusion Criteria

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03670641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.