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Posted by on Jun 27, 2015 in Diabetes mellitus | 0 comments

In a nutshell

This trial aimed to determine the safety and effectiveness of an artificial pancreas in type 1 diabetics living at home.

Some background

An insulin pump allows patients with type 1 diabetes (T1D) to enter in the carbohydrate content of a meal and the pump releases insulin based on this. A continuous glucose monitor (CGM) is a device which allows patients to view their blood glucose (sugar) levels every few minutes. This device receives information about the blood glucose levels though a sensor placed underneath the skin.

The combination of both the insulin pump and CGM is called the sensor-augmented insulin pump (SAP). A closed loop delivery system (artificial pancreas) differs from SAP in that the CGM measures blood glucose levels and sends information to the insulin pump wirelessly. This allows the insulin pump to release insulin in a glucose-dependent manner. The artificial pancreas is currently being investigated in clinical trials.

The MD-logic system is an artificial pancreas which has been designed to enhance safety and reduce faults. Its safety and effectiveness for overnight at-home use in T1D patients has only been assessed for a period of 3 weeks.

Methods & findings

This trial aimed to determine the safety and effectiveness of the MD-logic system at night in T1D patients living at home.

This trial involved 24 T1D patients. Participants used SAP for 6 weeks and used the MD-logic system for another 6 weeks. The CGM recorded the blood glucose levels in patients at night.

The number of times in which blood glucose levels were in the target range of 3.9-7.8 mmol/L increased by 21.8% when MD-logic was used. Time spent in hypoglycemia (blood glucose less than 3.9 mmol/L) was reduced by 40.2% with MD-logic compared to SAP. Patients experienced high blood glucose levels (more than 10 mmol/L) on 52.2% fewer nights when MD-logic was used in comparison to SAP.

The total insulin dose required at night and during the day was lower when patients used MD-logic. Severe side effects did not occur during use of the MD-logic system.

The bottom line

This trial concluded that the MD-logic system is safe and effective for long-term at home use in T1D patients. 

The fine print

A small sample size of 24 patients was involved. Extending the study beyond a total of 12 weeks would also be ideal. 

What’s next?

Consult with your physician regarding the availability of insulin pumps and continuous glucose monitors to improve blood glucose levels.

Published By :

Diabetes Care

Date :

Jul 30, 2014

Original Title :

MD-Logic Overnight Control for 6 Weeks of Home Use in Patients With Type 1 Diabetes: Randomized Crossover Trial.

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