Clinical trial NCT03987191: Insulin Pump to Multiple Daily Injection Transition Clinical Trial
Official title: Successful Transition From Insulin Pump to Multiple Daily Injections Using Insulin Degludec in Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups
timeFrame: 7 days from the randomization
Secondary outcomes:
measure: Time Spent in CGM-measured "Time-in-range"(Glucose Levels ≥70 mg /dl and ≤180 mg/dl) Between Two Groups
timeFrame: 7 days from the randomization
measure: Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups
timeFrame: 7 days from the randomization
measure: 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
timeFrame: 7 days from the randomization
measure: Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization
timeFrame: 72 hours from the randomization
measure: Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups
timeFrame: 7 days from the randomization
measure: Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups
timeFrame: 7 days from the randomization
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center for Diabetes
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Viral Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: