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

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Multiple daily ijnection using Insulin Degludec and Insulin Aspart

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care Transition

Inverstigational Transition

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups

CGM time below 70 between two groups

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

Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization

no of correction boluses between two groups

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.

Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups

PRO between two groups

Full Information

NCT ID

NCT03987191

First Posted

June 5, 2019

Last Updated

September 9, 2021

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT03987191

Brief Title

Insulin Pump to Multiple Daily Injection Transition Clinical Trial

Acronym

TRANSITION

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

January 10, 2020 (Actual)

Primary Completion Date

October 8, 2020 (Actual)

Study Completion Date

October 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care Transition

Arm Type

Active Comparator

Arm Description

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

Arm Title

Inverstigational Transition

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Multiple daily ijnection using Insulin Degludec and Insulin Aspart

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups

Description

The primary outcome will be time spent in CGM glucose >180 mg/dL (hyperglycemia) during 7days of randomization period between two groups.

Time Frame

7 days from the randomization

Secondary Outcome Measure Information:

Title

Time Spent in CGM-measured "Time-in-range"(Glucose Levels ≥70 mg /dl and ≤180 mg/dl) Between Two Groups

Description

CGM TIR between two groups

Time Frame

7 days from the randomization

Title

Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups

Description

CGM time below 70 between two groups

Time Frame

7 days from the randomization

Title

Description

Frequency of SH and DKA between two groups

Time Frame

7 days from the randomization

Title

Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization

Description

no of correction boluses between two groups

Time Frame

72 hours from the randomization

Title

Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups

Description

Time Frame

7 days from the randomization

Title

Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups

Description

PRO between two groups

Time Frame

7 days from the randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Viral Shah, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barbara Davis Center for Diabetes

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified academic researchers may request access to de-identified participant level data related to the study. The request letter with details such as reasons for data request, plan for data analysis, publication and so on should be emailed/mailed to the PI of the study (viral.shah@cuanschutz.edu).

IPD Sharing Time Frame

The data will be available after the publication. The data sharing details will be provided in the manuscript.

IPD Sharing Access Criteria

The committee (PI, statistician and Sponsor) will decide on appropriate request for data sharing.

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Insulin Pump to Multiple Daily Injection Transition Clinical Trial

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