Insulin Pump to Multiple Daily Injection Transition Clinical Trial
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Multiple daily ijnection using Insulin Degludec and Insulin Aspart
Intervention description: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Intervention MeSH terms: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥18 years and ≤ 65 years

          2. Patients with T1D diagnosed for at least 12 months

          3. Point-of-care HbA1c levels between ≥6.5% and ≤ 8.5%

          4. Patients on CSII (any insulin pump) for at least past 6 months

          5. Willing and able to wear a blinded CGM during the time of study period

          6. Willing to perform self-monitoring of blood glucose (SMBG) at least 4 times a day

          7. Ability to provide informed consent before any trial-related activities

          8. Not willing to or plan any travel out of Colorado during the 3 weeks of study period

          9. Willing to use insulin degludec in the morning once a day

        Exclusion Criteria:

          1. Age <18 years and > 65years

          2. HbA1c >8.5 % at screening

          3. Less than 12 months of insulin treatment

          4. Patients on 670G or Tandem Control IQ (Medtronic and Tandem Hybrid Closed-loop
             systems) and not willing use manual mode during the study period

          5. Patients with T1D using any glucose lowering medications other than insulin

          6. Pregnancy, breast feeding, and positive pregnancy test during screening

          7. Women of childbearing age wanting to become pregnant or not using adequate
             contraceptive measures

          8. Current or recent (< 2 weeks prior to visit 1) use of any steroidal medication, or
             anticipated steroidal treatment, during the study period

          9. eGFR below 45 ml/min/1.73 m^2 using MDRD formula

         10. History of severe hypoglycemia in the previous 3 months

         11. History of diabetic ketoacidosis (DKA) requiring hospitalization in the past 3 months

         12. History of allergy to any form of insulin or its excipients

         13. History of allergy to adhesives

         14. Unwilling to use blinded CGM during the study period

         15. Unwilling to perform SMPG at least 4 times a day

         16. Known history of alcohol abuse or illicit drug use within 6 months prior to screening

         17. Use of investigational drugs within 5 half-lives prior to screening

         18. Participation to other study trials during the study period

         19. Elevated liver enzymes (AST and ALT) 3 times the upper limit of normal

         20. Hypoglycemia unawareness defined as GOLD score ≥4 [20]

         21. Any comorbidities or medical conditions that make a person unfit for the study at the
             discretion of the investigators

         22. Anticipated travel across different time zones (difference greater than 4 hours) or
             anticipated change in physical activities or diet at the discretion of the
             investigators.