Trial Outcomes & Findings for Flash-glucose Monitoring in Sub-optimally Controlled Type 1 Diabetes (FLASH-UK) (NCT NCT03815006)

Results Overview

The primary outcome is difference in HbA1c between the two groups at 24 weeks.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

156 participants

Primary outcome timeframe

24 weeks

Results posted on

2023-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Free Style Libre 2 Device At the start, a blood sample will be taken for the measurement of HbA1c. Training and education on the use of FSL2 will be provided by the research team. Participants will be advised to use flash glucose monitoring continuously for the next 24 weeks. Free Style Libre 2: FreeStyle Libre 2 (FSL2) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes (T1D).	Self-monitoring of Blood Glucose At the start, a blood sample will be taken for the measurement of HbA1c. Masked FSL will be applied for two weeks, during the last two weeks of control period. Education will focus on using fingerstick measurement for treatment optimisation.
Overall Study STARTED	78	78
Overall Study COMPLETED	78	78
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Flash-glucose Monitoring in Sub-optimally Controlled Type 1 Diabetes (FLASH-UK)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Free Style Libre 2 Device n=78 Participants At the start, a blood sample will be taken for the measurement of HbA1c. Training and education on the use of FSL2 will be provided by the research team. Participants will be advised to use flash glucose monitoring continuously for the next 24 weeks. Free Style Libre 2: FreeStyle Libre 2 (FSL2) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes (T1D).	Self-monitoring of Blood Glucose n=78 Participants At the start, a blood sample will be taken for the measurement of HbA1c. Masked FSL will be applied for two weeks, during the last two weeks of control period. Education will focus on using fingerstick measurement for treatment optimisation.	Total n=156 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 14 • n=39 Participants	44 years STANDARD_DEVIATION 15 • n=41 Participants	44 years STANDARD_DEVIATION 15 • n=35 Participants
Sex: Female, Male Female	33 Participants n=39 Participants	36 Participants n=41 Participants	69 Participants n=35 Participants
Sex: Female, Male Male	45 Participants n=39 Participants	42 Participants n=41 Participants	87 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	3 Participants n=41 Participants	3 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) White	77 Participants n=39 Participants	75 Participants n=41 Participants	152 Participants n=35 Participants
Race (NIH/OMB) More than one race	1 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment United Kingdom	78 participants n=39 Participants	78 participants n=41 Participants	156 participants n=35 Participants
Glycated Haemoglobin levels	71.6 mmol/mol STANDARD_DEVIATION 9.5 • n=39 Participants	69.9 mmol/mol STANDARD_DEVIATION 8.5 • n=41 Participants	70.8 mmol/mol STANDARD_DEVIATION 9.0 • n=35 Participants

PRIMARY outcome

Timeframe: 24 weeks

The primary outcome is difference in HbA1c between the two groups at 24 weeks.

Outcome measures

Outcome measures
Measure	Free Style Libre 2 Device n=72 Participants At the start, a blood sample will be taken for the measurement of HbA1c. Training and education on the use of FSL2 will be provided by the research team. Participants will be advised to use flash glucose monitoring continuously for the next 24 weeks. Free Style Libre 2: FreeStyle Libre 2 (FSL2) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes (T1D).	Self-monitoring of Blood Glucose n=69 Participants At the start, a blood sample will be taken for the measurement of HbA1c. Masked FSL will be applied for two weeks, during the last two weeks of control period. Education will focus on using fingerstick measurement for treatment optimisation.
HbA1c Level at 24 Weeks	62.8 mmol/mol Standard Deviation 8.5	67.7 mmol/mol Standard Deviation 9.8

SECONDARY outcome

Timeframe: 12 weeks

This is the difference in HbA1c between the two groups at 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

This is the comparison between arms of percentage with HbA1c ≤ 53 mmol/mol (7.0%) at 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

This is the comparison between arms of percentage with HbA1c ≤ 53 mmol/mol (7.0%) at 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Time spent in the target glucose range between 3.9 to 10.0 mmol/l (70 to 180mg/dl).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Time spent below target glucose (\<3.9mmol/l) (\<70mg/dl)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Time spent above target glucose (10.0 mmol/l) (180 mg/dl)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Average glucose levels

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Standard deviation glucose levels

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Coefficient of variation glucose levels

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

The time with sensor glucose levels \< 3.5 mmol/l (63 mg/dl)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

The time with sensor glucose levels \< 3.0 (54mg/dl)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

The time with sensor glucose levels \< 2.8 mmol/l (50 mg/dl)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

The time with sensor glucose levels in the significant hyperglycaemia (glucose levels \> 16.7 mmol/l) (300mg/dl)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

AUC of glucose below 3.0mmol/l (54mg/dl)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Comparison between arms of Total daily average insulin dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Comparison between arms of Daily average basal insulin dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Comparison between arms of Daily average bolus dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Average number of boluses of rapid acting insulin per day

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Number of Freestyle Libre scans per day in the intervention arm only

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Frequency of severe hypoglycaemic episodes as defined by American Diabetes Association

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Frequency of significant ketosis events (plasma ketones \>3mmol/l)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Nature and severity of other adverse events.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Type 1 Diabetes Distress Scale score compared between arms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

EQ-5D-5L Quality of Life questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Patient Health Questionnaire: score of 5-9 would be minimal symptoms. any score large than 20 would be categorised as severe major depression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Diabetes fear of injecting and self-testing questionnaire: 15 questions, 6 for Fear of Self injecting, 9 for fear of self testing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

The revised Diabetes Eating Problem Survey

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Average number of days of usage per week

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Diabetes Treatment Satisfaction Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Glucose Monitoring Satisfaction Survey: 15 questions ranging from 1-5.

Outcome measures

Outcome data not reported

Adverse Events

Free Style Libre 2 Device

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Self-monitoring of Blood Glucose

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Free Style Libre 2 Device n=78 participants at risk At the start, a blood sample will be taken for the measurement of HbA1c. Training and education on the use of FSL2 will be provided by the research team. Participants will be advised to use flash glucose monitoring continuously for the next 24 weeks. Free Style Libre 2: FreeStyle Libre 2 (FSL2) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes (T1D).	Self-monitoring of Blood Glucose n=78 participants at risk At the start, a blood sample will be taken for the measurement of HbA1c. Masked FSL will be applied for two weeks, during the last two weeks of control period. Education will focus on using fingerstick measurement for treatment optimisation.
Endocrine disorders Hospital admission	2.6% 2/78 • Number of events 2 • 6 months	2.6% 2/78 • Number of events 2 • 6 months

Other adverse events

Other adverse events
Measure	Free Style Libre 2 Device n=78 participants at risk At the start, a blood sample will be taken for the measurement of HbA1c. Training and education on the use of FSL2 will be provided by the research team. Participants will be advised to use flash glucose monitoring continuously for the next 24 weeks. Free Style Libre 2: FreeStyle Libre 2 (FSL2) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes (T1D).	Self-monitoring of Blood Glucose n=78 participants at risk At the start, a blood sample will be taken for the measurement of HbA1c. Masked FSL will be applied for two weeks, during the last two weeks of control period. Education will focus on using fingerstick measurement for treatment optimisation.
Product Issues skin reaction due to sensor	1.3% 1/78 • Number of events 1 • 6 months	0.00% 0/78 • 6 months

Additional Information

Dr Lala Leelarathna

Manchester University NHS Foundation Trust

Phone: 01612766706

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place