Insulin Pump to Multiple Daily Injection Transition Clinical Trial

NCT ID: NCT03987191

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-10
• Study Completion Date: 2020-10-08

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care 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

Group Type: ACTIVE_COMPARATOR

Multiple daily ijnection using Insulin Degludec and Insulin Aspart

Intervention Type: DRUG

Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Inverstigational Transition

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

Group Type: EXPERIMENTAL

Multiple daily ijnection using Insulin Degludec and Insulin Aspart

Intervention Type: DRUG

Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Interventions

Multiple daily ijnection using Insulin Degludec and Insulin Aspart

Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Viral Shah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Barbara Davis Center for Diabetes

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-0924

Identifier Type: -

Identifier Source: org_study_id