Trial Outcomes & Findings for Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion (NCT NCT04267770)

Results Overview

Absolute change in insulin basal rate over 24 hours after 3 rounds of basal rate testing (calculated by the sum of absolute changes for each 1 hour block compared with baseline)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

over 24 hours after 3 rounds of basal rate testing

Results posted on

2020-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	Circadian Insulin Infusion Rates Initial variable basal rates aim to replicate circadian changes in insulin requirements and are derived from total basal insulin in adults over 24 years old, and from weight in adults aged 18 to 24 years. Insulin (circadian): Participant's own insulin adjusted to circadian infusion rates	Flat Rates flat basal rate Insulin (flat rate): Participant's own insulin set to flat basal rates
Overall Study STARTED	9	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Circadian Insulin Infusion Rates n=9 Participants Initial variable basal rates aim to replicate circadian changes in insulin requirements and are derived from total basal insulin in adults over 24 years old, and from weight in adults aged 18 to 24 years. Insulin (circadian): Participant's own insulin adjusted to circadian infusion rates	Flat Rates n=8 Participants flat basal rate Insulin (flat rate): Participant's own insulin set to flat basal rates	Total n=17 Participants Total of all reporting groups
Age, Continuous	33.3 years STANDARD_DEVIATION 8.6 • n=9 Participants	33.3 years STANDARD_DEVIATION 8.6 • n=8 Participants	33.3 years STANDARD_DEVIATION 8.6 • n=17 Participants
Sex: Female, Male Female	8 Participants n=9 Participants	3 Participants n=8 Participants	11 Participants n=17 Participants
Sex: Female, Male Male	1 Participants n=9 Participants	5 Participants n=8 Participants	6 Participants n=17 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: over 24 hours after 3 rounds of basal rate testing

Absolute change in insulin basal rate over 24 hours after 3 rounds of basal rate testing (calculated by the sum of absolute changes for each 1 hour block compared with baseline)

Outcome measures

Outcome measures
Measure	Circadian Insulin Infusion Rates n=9 Participants Initial variable basal rates aim to replicate circadian changes in insulin requirements and are derived from total basal insulin in adults over 24 years old, and from weight in adults aged 18 to 24 years. Insulin (circadian): Participant's own insulin adjusted to circadian infusion rates	Flat Rates n=8 Participants flat basal rate Insulin (flat rate): Participant's own insulin set to flat basal rates
Change in Basal Insulin Rate	1.8 Units of insulin Interval 0.63 to 2.99	1.49 Units of insulin Interval 0.83 to 1.94

Adverse Events

Circadian Insulin Infusion Rates

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Flat Rates

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nick Oliver

Imperial College London

Phone: +44 20 7594 1796

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place