Clinical trials factsheet

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IMPACT:

Type 1 Hypoglycaemia Study

Title – Randomised Controlled Study (RTC) to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes

  • Objective: the primary objective of this study is to demonstrate the impact on time in hypoglycaemia (number of hours per day of hypoglycaemic excursions < 70 mg/dL) using Abbott’s Flash Glucose Monitoring System compared to SMBG testing at 6 months.

  • The study is assigned to assess the clinical outcomes and safety of Abbott’s Flash Glucose Monitoring System in the home use setting.

  • The primary study objective is to evaluate the effectiveness of Abbott’s Flash Glucose Monitoring System in showing
    a reduction in hypoglycemia in Type 1 diabetes as compared to Self-Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design.

  • Total of twenty-six (26) sites (across Netherlands, Germany, Spain, Austria, Sweden)

  • >225 Subjects with T1 DM (MDI or CSII)

  • Subjects with HbA1c <7.5%

  • Study results are expected in Q2 2015

REPLACE:

Type 2 HbA1c

Title – Randomised Controlled Study (RCT) to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes

• Total of twenty six (26) sites (across Germany, France, UK)

• Primary endpoint (Change in HbA1c) at 6 months compared to Control Group

• + 6 month extension for device intervention group

• >210 Subjects with T2 DM (MDI)

• Subjects with HbA1c >7.5%

• Study detail Clinicaltrials.gov (NCT02082184)

• Enrolment began in March 2014 and is not yet completed

• Preliminary endpoint report is due May 2015

Fonte Abbott