Posted by on Dec 20, 2019 in Diabetes mellitus | 0 comments

In a nutshell

This study is looking for patients with diabetes taking insulin to test a mobile app that helps patients understand how blood glucose levels change. The main outcome that will be measured is the average blood glucose level at the beginning versus the end of the study. This study is recruiting in Boston, MA, the US.

The details

Patients with diabetes have high blood glucose levels. This can cause other health complications. Blood glucose levels naturally rise after a meal and fall during periods when a person is not eating, such as sleep. Insulin is a treatment that helps to lower blood glucose levels. However, it can be difficult to control the amount of insulin after a meal or around bedtime. If blood glucose levels drop too low (hypoglycemia), other health complications can arise such as fatigue. Patients’ awareness and understanding of the problem can help them balance insulin levels. 

This trial aims to use a mobile app that compares patients’ estimates of their blood glucose levels with actual readings to help patients control insulin doses more effectively. The main outcome that will be measured is the average blood glucose level at the beginning versus the end of the study.

Who are they looking for?

This trial is recruiting 70 patients with either type 1 or type 2 diabetes. Patients must be taking multiple daily insulin injections or have an insulin pump. Patients must be aged 18 or older. Patients’ HbA1c values (a measure of blood glucose for the previous 3 months) must be between 7 and 10.5% or they must have experienced hypoglycemia 3 or more times a week. Patients must own an Android or iOS smartphone with regular internet access.

Patients receiving insulin in a closed-loop pump, such as the Medtronic 670G or OpenAPS, cannot participate.

How will it work

All patients will interact with the Control:Diabetes mobile app. Patients will be asked each morning to predict their blood glucose levels. Patients will then enter their actual blood glucose level and, if there is a significant difference between estimated and actual, will be asked to explain why they think there was a difference. 

The average change in blood glucose and the number of hypoglycemia events between the start and the end of the study will be measured.

Clinical trial locations

Locations near 20147, United States (Change):
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Study ID:NCT04158921
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