Trial Outcomes & Findings for Advanced Bolus Calculator for Type 1 Diabetes (ABC4D) (NCT NCT02053051)

NCT ID: NCT02053051

Last Updated: 2024-08-16

Results Overview

Change in HbA1c

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2024-08-16

Participant Flow

From diabetes clinics

Participant milestones

Measure	Phase 4 Intervention (ABC4D) & RT - CGM Intervention (ABC4D) \& Real-time continuous glucose monitoring over 6 months	Phase 4 Control: Standard Bolus Calculator & RT-CGM Control: standard bolus calculator \& Real-time continuous glucose monitoring over 6 months
Overall Study STARTED	13	12
Overall Study COMPLETED	13	12
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

Measure	Phase 4: Intervention (ABC4D) & RT - CGM n=13 Participants Intervention (ABC4D) \& Real-time continuous glucose monitoring over 6 months	Phase 4 Control: Standard Bolus Calculator & RT-CGM n=12 Participants Control: standard bolus calculator \& Real-time continuous glucose monitoring over 6 months	Total n=25 Participants Total of all reporting groups
Age, Continuous	39.6 years STANDARD_DEVIATION 9.7 • n=13 Participants	36.3 years STANDARD_DEVIATION 14.1 • n=12 Participants	38 years STANDARD_DEVIATION 12 • n=25 Participants
Sex: Female, Male Female	6 Participants n=13 Participants	9 Participants n=12 Participants	15 Participants n=25 Participants
Sex: Female, Male Male	7 Participants n=13 Participants	3 Participants n=12 Participants	10 Participants n=25 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	13 participants n=13 Participants	12 participants n=12 Participants	25 participants n=25 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Change in HbA1c

Outcome measures

Measure	Intervention (ABC4D) & RT - CGM n=13 Participants Intervention (ABC4D) \& Real-time continuous glucose monitoring	Control: Standard Bolus Calculator & RT-CGM n=12 Participants Control: standard bolus calculator \& Real-time continuous glucose monitoring
HbA1c	-5.0 mmol/mol Interval -11.5 to -4.0	-3.0 mmol/mol Interval -10.3 to -0.8

SECONDARY outcome

Timeframe: Baseline and 6 months

Difference between baseline and 6-month endpoint.

Outcome measures

Measure	Intervention (ABC4D) & RT - CGM n=13 Participants Intervention (ABC4D) \& Real-time continuous glucose monitoring	Control: Standard Bolus Calculator & RT-CGM n=12 Participants Control: standard bolus calculator \& Real-time continuous glucose monitoring
Percentage Time in Target Range	0.9 Percentage Interval -1.4 to 3.6	0.0 Percentage Interval -3.6 to 3.8

SECONDARY outcome

Timeframe: Baseline and 6 months

Difference from baseline to 6-month endpoint.

Outcome measures

Measure	Intervention (ABC4D) & RT - CGM n=13 Participants Intervention (ABC4D) \& Real-time continuous glucose monitoring	Control: Standard Bolus Calculator & RT-CGM n=12 Participants Control: standard bolus calculator \& Real-time continuous glucose monitoring
Percentage Time in Hypoglycaemia	0.5 percentage Interval 0.1 to 2.4	-0.2 percentage Interval -1.6 to 4.6

Adverse Events

Phase 4 Intervention & Control

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

Prof Nick Oliver

Imperial College London

Phone: 02075941862

Email: nick.oliver@imerial.ac.uk

Results disclosure agreements

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