Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes

Completed

• Conditions: Type 1 Diabetes Mellitus Maturity Onset

• Registration Number: NCT03047486
• Lead Sponsor: University Hospital, Caen

Brief Summary

The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which allows the continuous measure of interstitial glucose rate. The results are available in real time to the user, who can so use them to optimize the adjustment of its treatment by insulin pump. Since a few years, several research programs aim for finalizing an automated system using the data of real time interstitial glucose to adjust automatically, via an algorithm, the release of insulin by the pump. This type of closed-loop system is for the moment only experimental, not still widely available in routine. On the other hand, rudimentary regulation systems partially automated already exist and can be used in common clinical practice. One of these systems, Smartguard ®, allows this type of regulation to decrease the hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo minimizer which interrupts the basal output when the algorithm embarked on the pump determines thanks to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The efficiency of this system to reduce hypoglycemias was proved by several studies in pediatric and adult populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes Sci Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published data concerning the method of use of this system (sensor et pump initial configuration; patient education), nor the evolution of the sensor and pump parameters during the use.

The aim of this observationnelle study is to collect the data of efficiency, safety and use of the system Smartguard ® in common clinical practice in an adult population of subjects DT1.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study Start: 2017-02-01
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Type 1 diabetes ≥ 1 year
• CSII ≥ 6 months
• Previous education to flexible insulin therapy
• Patient willing to use sensors and smartguard option for 1 year
• A1c ≥ 7.5% and/or severe hypoglycemia ≥ 2 episodes during the last 6 month and/or recurrent hypoglycemia and/or hypoglycemia unawareness and/or brittle diabetes

Exclusion Criteria

• No access to a computer and/or to the web making it impossible to follow patients through telemedicine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glucose TIR (time in range) from CGM recording	change between baseline and after 12 month	TIR will be calculated from the CGM recording, thanks to the medtronic carelink software
Glucose Time below range (hypoglycemia < 70 mg/dl) from CGM recording	change between baseline and after 12 month	Time below range will be calculated from the CGM recording, thanks to the medtronic carelink software

Secondary Outcome Measures

Name	Time	Method
HbA1c	month 0, 3, 6, 9, 12

Trial Locations

Locations (1)

Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen; 🇫🇷 Caen, France