Trial Outcomes & Findings for Insulin Pump to Multiple Daily Injection Transition Clinical Trial (NCT NCT03987191)

NCT ID: NCT03987191

Last Updated: 2021-09-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 38 participants
• Primary outcome timeframe: 7 days from the randomization
• Results posted on: 2021-09-13

Participant Flow

3 screen failed, 1 participant was lost to follow-up prior to screening, and 2 withdrew from study prior to randomization.

Participant milestones

Measure	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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Investigational 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Overall Study STARTED	17	15
Overall Study Data Collected	17	13
Overall Study COMPLETED	17	13
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Investigational 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Overall Study COVID-19 related research disruption	0	2

Baseline Characteristics

Insulin Pump to Multiple Daily Injection Transition Clinical Trial

Baseline characteristics by cohort

Measure	Standard of Care Transition n=17 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Investigational Transition n=13 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Total n=30 Participants Total of all reporting groups
Age, Continuous	35.7 Years STANDARD_DEVIATION 9.1 • n=5 Participants	38.2 Years STANDARD_DEVIATION 9.5 • n=7 Participants	36.8 Years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized White	15 Number of participants n=5 Participants	13 Number of participants n=7 Participants	28 Number of participants n=5 Participants
Race/Ethnicity, Customized Other	2 Number of participants n=5 Participants	0 Number of participants n=7 Participants	2 Number of participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	13 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Standard of Care Transition n=17 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Investigational Transition n=13 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Time Spent With CGM Glucose Levels >180mg/dl Between Two Groups	46.3 percentage of time spent >180 mg/dL Interval 43.5 to 49.1	38.5 percentage of time spent >180 mg/dL Interval 30.7 to 47.1

SECONDARY outcome

Timeframe: 7 days from the randomization

CGM TIR between two groups

Outcome measures

Measure	Standard of Care Transition n=17 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Investigational Transition n=13 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Time Spent in CGM-measured "Time-in-range"(Glucose Levels ≥70 mg /dl and ≤180 mg/dl) Between Two Groups	47.8 percentage of time spent in range Interval 44.1 to 52.1	56.5 percentage of time spent in range Interval 51.0 to 63.9

SECONDARY outcome

Timeframe: 7 days from the randomization

CGM time below 70 between two groups

Outcome measures

Measure	Standard of Care Transition n=17 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Investigational Transition n=13 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Time Spent in CGM-measured Hypoglycemia < 70 mg/dl Between Two Groups	3.9 percentage of time below range Interval 2.4 to 7.2	2.1 percentage of time below range Interval 1.0 to 5.4

SECONDARY outcome

Timeframe: 7 days from the randomization

Frequency of SH and DKA between two groups

Outcome measures

Measure	Standard of Care Transition n=17 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Investigational Transition n=13 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
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 Participants with Severe Hypoglycemia	0 Participants	0 Participants
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 Participants with Diabetic Ketoacidosis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 72 hours from the randomization

no of correction boluses between two groups

Outcome measures

Measure	Standard of Care Transition n=17 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Investigational Transition n=13 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Number of Boluses (Correction Boluses) Between Groups During First 72 Hours of Randomization	6.5 Boluses per day Interval 4.5 to 8.7	4.0 Boluses per day Interval 3.0 to 6.5

SECONDARY outcome

Timeframe: 7 days from the randomization

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.

Outcome measures

Measure	Standard of Care Transition n=17 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Investigational Transition n=13 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Insulin Delivery Satisfaction (IDSS Survey) Between Two Groups	3.9 score on a scale Interval 3.9 to 4.3	3.9 score on a scale Interval 3.8 to 4.1

SECONDARY outcome

Timeframe: 7 days from the randomization

PRO between two groups

Outcome measures

Measure	Standard of Care Transition n=17 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Investigational Transition n=13 Participants 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups Percent work time missed due to problem	0.0 Percent Interval 0.0 to 0.0	0.0 Percent Interval 0.0 to 0.0
Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups Percent impairment while working	0.2 Percent Interval 0.1 to 0.3	0.2 Percent Interval 0.1 to 0.3
Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups Percent overall work impairment	1.0 Percent Interval 1.0 to 1.0	1.0 Percent Interval 1.0 to 1.0
Work Productivity and Activity Impairment (WPAI:SHP Version 2 Questionnaire) Between Two Groups Percent activity impairment due to problem	0.1 Percent Interval 0.1 to 0.2	0.2 Percent Interval 0.2 to 0.4

Adverse Events

Standard of Care Transition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Investigational Transition

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard of Care Transition n=17 participants at risk 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	Investigational Transition n=13 participants at risk 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 Multiple daily ijnection using Insulin Degludec and Insulin Aspart: Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Respiratory, thoracic and mediastinal disorders AE unrelated to the study	0.00% 0/17 • 7 Days	15.4% 2/13 • Number of events 2 • 7 Days

Additional Information

Dr. Viral Shah, Principal Investigator

University of Colorado Anschutz Medical Campus

Phone: 303-724-8186

Email: viral.shah@cuanschutz.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place