A Study on the effectiveness of alarms for low glucose in insulin-treated diabetic patients driving daily

JRCT ID: jRCTs042200089

Registered date:28/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diabetes
• Date of first enrollment: 06/07/2021
• Target sample size: 30
• Study type: Interventional

Intervention(s)

crossover trial:
alarms for low glucose by FreeStyle Libre 2

Outcome(s)

• Primary Outcome: Duration of hypoglycemia (<70mg/dl)

Secondary Outcome

Frequency and duration of hypoglycemia (<70mg/dl, <54mg/dl, <45mg/dl)
Hypoglycemia during driving
Unconscious hypoglycemia
Hypoglycemia during daytime and bedtime
Frequency of hypoglycemia between disease types
Mean glucose, glucose variability measures, HbA1c
Risk factors for hypoglycemia
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Response / impression when alert for low glucose
Severe hypoglycemia, traffic accident

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Diabetes patients using insulin
Patients who drive a car at least 3 times a week
Patients who are 20 years old and over
Patients who understand the research content and agree

Exclude criteria

Patients who are undesirable to drive a car due to complications
Patients who doctor judged that car operation is not desirable
Patients who are pregnant
Patients who are on dialysis
Patients who use other implanted medical devices, such as pacemakers

Related Information

• Primary Sponsor: Arima Hiroshi
• Source(s) of Monetary Support: Abbott Diabetes Care