Insulin Pump to Multiple Daily Injection Transition Clinical Trial (TRANSITION)
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years and ≤ 65 years
- Patients with T1D diagnosed for at least 12 months
- Point-of-care HbA1c levels between ≥6.5% and ≤ 8.5%
- Patients on CSII (any insulin pump) for at least past 6 months
- Willing and able to wear a blinded CGM during the time of study period
- Willing to perform self-monitoring of blood glucose (SMBG) at least 4 times a day
- Ability to provide informed consent before any trial-related activities
- Not willing to or plan any travel out of Colorado during the 3 weeks of study period
- Willing to use insulin degludec in the morning once a day
Exclusion Criteria:
- Age <18 years and > 65years
- HbA1c >8.5 % at screening
- Less than 12 months of insulin treatment
- Patients on 670G or Tandem Control IQ (Medtronic and Tandem Hybrid Closed-loop systems) and not willing use manual mode during the study period
- Patients with T1D using any glucose lowering medications other than insulin
- Pregnancy, breast feeding, and positive pregnancy test during screening
- Women of childbearing age wanting to become pregnant or not using adequate contraceptive measures
- Current or recent (< 2 weeks prior to visit 1) use of any steroidal medication, or anticipated steroidal treatment, during the study period
- eGFR below 45 ml/min/1.73 m^2 using MDRD formula
- History of severe hypoglycemia in the previous 3 months
- History of diabetic ketoacidosis (DKA) requiring hospitalization in the past 3 months
- History of allergy to any form of insulin or its excipients
- History of allergy to adhesives
- Unwilling to use blinded CGM during the study period
- Unwilling to perform SMPG at least 4 times a day
- Known history of alcohol abuse or illicit drug use within 6 months prior to screening
- Use of investigational drugs within 5 half-lives prior to screening
- Participation to other study trials during the study period
- Elevated liver enzymes (AST and ALT) 3 times the upper limit of normal
- Hypoglycemia unawareness defined as GOLD score ≥4 [20]
- Any comorbidities or medical conditions that make a person unfit for the study at the discretion of the investigators
- 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.
Sites / Locations
- Barbara Davis Center for Diabetes
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard of Care Transition
Inverstigational Transition
Stopping of insulin pump on the day of randomization and starting insulin degludec in 1:1 ratio (same units as total basal insulin on pump) and insulin Aspart for meals and corrections
Administration of insulin degludec in 1:1 ratio (same units as total basal insulin on pump) on the day of randomization AND concomitant use of the insulin pump for 48 hours from transition, where insulin pump basal rate will be reduced by 50% during the first 24 hours from transition and by 75% during 24 to 48 hours from transition. Insulin pump will be disconnected after 48 hours from transition