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Insulin Pump to Multiple Daily Injection Transition Clinical Trial (TRANSITION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03987191
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 11, 2020
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Multiple daily ijnection using Insulin Degludec and Insulin Aspart Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Successful Transition From Insulin Pump to Multiple Daily Injections Using Insulin Degludec in Adults With Type 1 Diabetes
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Standard of Care Transition
Stopping of insulin pump on day 1 and starting long acting basal insulin degludec in 1:1 ratio ( exactly same units as basal insulin on pump) on day 1 plus insulin Nolovog for meals and corrections
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

Experimental: Inverstigational Transition
Overlap between insulin pump basal rate and insulin degludec administration for first 48 hours. However, insulin pump basal rate would be reduced over time per protocol.
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

Primary Outcome Measures :
  1. Time spent with CGM glucose levels >180mg/dl [ Time Frame: 7 days from the randomization ]
    The primary outcome will be time spent in CGM glucose >180 mg/dL (hyperglycemia) during 7days of randomization period between two groups. The differences in CGM metrics will be examined using student t-test and Linear regression analysis will be used to examine outcomes by treatment group while adjusting for potential residual confounders if any. The analysis will be conducted as an intention-to-treat analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 (Medtronic Hybrid Closed-loop system) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03987191

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Contact: Viral Shah 3037248186

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United States, Colorado
Barbara Davis Center for Diabetes Recruiting
Aurora, Colorado, United States, 80045
Contact: Alaina Dougherty    303-724-6896    ALAINA.DOUGHERTY@CUANSCHUTZ.EDU   
Contact: Viral Shah, MD    303-724-8186   
Sponsors and Collaborators
University of Colorado, Denver
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Principal Investigator: Viral Shah, MD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver Identifier: NCT03987191    
Other Study ID Numbers: 19-0924
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs