Insulin Pump to Multiple Daily Injection Transition Clinical Trial

Type 1 Diabetes Clinical Trial

— TRANSITION  

Official title:

Successful Transition From Insulin Pump to Multiple Daily Injections Using Insulin Degludec in Adults With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987191
• Other study ID #: 19-0924
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2020
• Est. completion date: October 8, 2020

Study information

• Verified date: September 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 8, 2020
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Multiple daily ijnection using Insulin Degludec and Insulin Aspart
Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Locations

Country	Name	City	State
United States	Barbara Davis Center for Diabetes	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days from the randomization
Secondary	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	7 days from the randomization
Secondary	Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups	CGM time below 70 between two groups	7 days from the randomization
Secondary	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	7 days from the randomization
Secondary	Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization	no of correction boluses between two groups	72 hours from the randomization
Secondary	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.	7 days from the randomization
Secondary	Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups	PRO between two groups	7 days from the randomization