This randomized controlled, two arms, investigator initiated, intervention study is aimed to examine an investigational approach in contrast to the clinical standard of 1:1 dose basal insulin conversion in an attempt to lower the incidence and/or duration of hyperglycemia after transition from insulin pump to multiple daily injections in adults with type 1 diabetes.
Second generation long acting insulin, insulin degludec, has been shown to improve glycemic control and reduce hypoglycemia in patients with type 1 diabetes and insulin treated type 2 diabetes. However, it takes about 48 hours before glycemic benefits are noticeable. Therefore, transition from insulin pump to multiple daily injection using insulin degludec is associated with hyperglycemia during first 48 hours of transition. Considering this, this study proposes to evaluate an investigational strategy to improve glycemic control during transition from insulin pump to multiple daily injections using insulin degludec and insulin aspart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Barbara Davis Center for Diabetes
Aurora, Colorado, United States
Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups
The primary outcome will be time spent in CGM glucose \>180 mg/dL (hyperglycemia) during 7days of randomization period between two groups.
Time frame: 7 days from the randomization
Time Spent in CGM-measured "Time-in-range"(Glucose Levels ≥70 mg /dl and ≤180 mg/dl) Between Two Groups
CGM TIR between two groups
Time frame: 7 days from the randomization
Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups
CGM time below 70 between two groups
Time frame: 7 days from the randomization
Number of Participants With Severe Hypoglycemia as Defined by the ADA (Severe Cognitive Impairment Requiring External Assistance for Recovery) and Severe Hyperglycemia (BG≥250 Needing Hospitalization) Between Two Groups
Frequency of SH and DKA between two groups
Time frame: 7 days from the randomization
Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization
no of correction boluses between two groups
Time frame: 72 hours from the randomization
Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups
PRO between two groups. The Insulin delivery satisfaction survey (IDSS) measures diabetes patients' satisfaction with their insulin delivery system. Possible scores range from 1-5, with higher scores indicating higher satisfaction and a better outcome.
Time frame: 7 days from the randomization
Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups
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PRO between two groups
Time frame: 7 days from the randomization