Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Diabetes Mellitus
  • Diabetes Mellitus - Type 1
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is an open-label, randomized, controlled, two-way parallel study to compare glucose control between sensor-augmented MDI therapy and our basal-bolus optimizing algorithm over 3 months. Adults with type 1 diabetes who are enrolled in the study will randomly undergo one of the two interventions for the entire study duration.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The changes in eligibility criteria indicated below are from a previously approved amendment but were inadvertently omitted in the previous PRS update made in November of 2020. Therefore, this note serves to clarify the order of updates. Inclusion: HbA1c ? 7.5% in the last 2 months (modification) Ex...

The changes in eligibility criteria indicated below are from a previously approved amendment but were inadvertently omitted in the previous PRS update made in November of 2020. Therefore, this note serves to clarify the order of updates. Inclusion: HbA1c ? 7.5% in the last 2 months (modification) Exclusion: More than 1 slow-acting injection and unwilling to switch to once a day for the study (addition) Severe hypoglycemic episode within one month of admission (addition) In the subsequent amendment, we modified the timeframe for the HbA1c inclusion criterion to obtain a more accurate representation of their current glucose control at the time of enrollment.

Tracking Information

NCT #
NCT04123054
Collaborators
Not Provided
Investigators
Principal Investigator: Michael Tsoukas, MD RI-MUHC
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