Which is the best ultra-rapid acting insulin to improve postprandial glycemic variability? Comparison of insulin glulisine vs. insulin lispro vs. insulin aspart using FreeStyle Libre Pro: randomised triple crossover study

UMIN ID: UMIN000027368

Registered date:17/05/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 2017/05/17
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

FreeStyle Libre Pro is worn after admission. insulin glulisine are evaluated on day 3 and day 4. Then, insulin lispro are evaluated on day 8 and day 9. Then, insulin aspart are evaluated on day 13 and day 14.
FreeStyle Libre Pro is worn after admission. insulin aspart are evaluated on day 3 and day 4. Then, insulin glulisine are evaluated on day 8 and day 9. Then, insulin lispro are evaluated on day 13 and day 14.
FreeStyle Libre Pro is worn after admission. insulin lispro are evaluated on day 3 and day 4. Then, insulin aspart are evaluated on day 8 and day 9. Then, insulin glulisine are evaluated on day 13 and day 14.

Outcome(s)

• Primary Outcome: 08:00 to 24:00 percentage of time in target range (70~140 mg/dL)
• Secondary Outcome: 08:00 to 24:00 mean absolute glucose (MAG) 08:00 to 24:00 glycemic variability percentage (GVP) 08:00 to 24:00 mean glucose level 08:00 to 24:00 standard deviation (SD) 08:00 to 24:00 coefficient of variation (CV) Highest postprandial glucose level within 3 hours after each meal Differences between preprandial and highest postprandial glucose level for each meal Post-breakfast glucose gradient AOC (<70 mg/dL) for glycemic variability (0:00~8:00, 8:00~12:00, 12:00~18:00, 18:00~24:00) M-value (8:00~24:00,24h) MAGE ADRR Time from start of meal to the highest postprandial glucose level MODD 08:00 to 24:00 low blood glucose index (LBGI)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: Patients with severe renal dysfunction (serum creatinine level more than 2.0 mg/dL) Patients who were aware that they were hypoglycemic and took glucose tablets Patients considered not suitable for participation due to medical reasons

Related Information

• Primary Sponsor: General Inuyamachuo Hospital
• Source(s) of Monetary Support: Self funding