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

Type 1 Diabetes Mellitus Maturity Onset Clinical Trial

— Smartguard  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047486
• Other study ID #: 16-106
• Status: Completed
• Phase: N/A
• First received: February 7, 2017
• Last updated: January 24, 2018
• Start date: February 1, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: February 2017
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes Mellitus Maturity Onset

Locations

Country	Name	City	State
France	Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	daily insulin total dose		month 0, 3, 6, 9, 12
Other	basal / bolus ratio		month 0, 3, 6, 9, 12
Other	daily bolus number		month 0, 3, 6, 9, 12
Other	Mean daily hypoglycemic predictive-stop time		month 0, 3, 6, 9, 12
Other	Mean daily hypoglycemic-stop time		month 0, 3, 6, 9, 12
Other	Time Percentage with CGM Sensor Use Time		month 0, 3, 6, 9, 12
Other	Medical time at each consultation		month 0, 3, 6, 9, 12
Primary	Glucose TIR (time in range) from CGM recording	TIR will be calculated from the CGM recording, thanks to the medtronic carelink software	change between baseline and after 12 month
Primary	Glucose Time below range (hypoglycemia < 70 mg/dl) from CGM recording	Time below range will be calculated from the CGM recording, thanks to the medtronic carelink software	change between baseline and after 12 month
Secondary	HbA1c		month 0, 3, 6, 9, 12