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Clinical Trial Details

Trial ID: L4331
Source ID: NCT03670641
Associated Drug: Glargine
Title: Remission Through Early Monitored Insulin Therapy - Duration Month
Acronym: REMIT-DM
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03670641/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Glargine|DRUG: Lispro|DEVICE: Dexcom G6
Outcome Measures: Primary: 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: Number of Participants With A1C of <6.5% After CGM-guided Insulin Therapy Intervention, See if A1C achieves threshold \<6.5% with intensive daily titration of basal bolus insulin therapy, guided by the individual's continuous glucose monitoring value and trend arrow - all guided by our algorithm., 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, We wanted to ensure that during the course of the intensive CGM-guided insulin therapy, our algorithm would be able to avoid severe hypoglycemia, defined as a glucose reading of \<55mg/dL in the study participants, 4 weeks|See if Diabetes Distress is Affected With Intervention Via Problem Areas In Diabetes (PAID) - 5 Questionnaire Scale, Administer the PAID-5 scale, which is a measure of diabetes distress. The scale ranges from a minimum of 0 (not a problem) to a maximum score of 4 (serious problem). The sum of the five questions provides the participant's score with a score range of minimum score of 0 to a maximum score of 20. A total score of greater than or equal to 8 indicates possible diabetes related emotional distress, with a higher score indicating more significant distress. This will be given to participants to see if/how distress levels change via the intervention, 1 year|Percent Time Glucose Values Remain in Range While Wearing CGM During Insulin Intervention, Use CGM-captured glucose values to determine how often a participant's glucose levels were in range (percent time in range), 4 weeks|Number of Participants Achieving Euglycemic Glucose Targets Within a 4 Week Period, The design of the algorithm was to attempt to achieve glucose values in the normal glycemic range, as defined as fasting BG target 80-95 mg/dL, and 2 hour post prandial BG target 100-120 mg/dL, within 2 weeks of starting insulin and maintaining values until end of 4 week intervention. We wanted to see if our CGM-guided insulin algorithm could help participants achieve pre-defined euglycemic glucose targets in four week period, 4 weeks
Sponsor/Collaborators: Sponsor: Sandra Sobel
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-03-26
Completion Date: 2020-07-31
Results First Posted: 2021-10-12
Last Update Posted: 2021-10-12
Locations: UPMC Falk Diabetes Clinic, Pittsburgh, Pennsylvania, 15213, United States
URL: https://clinicaltrials.gov/show/NCT03670641