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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus Maturity Onset

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This prospective trial involved adult patients with Type 1 Diabetes for at least 1 year, and a treatement by insulin pump (CSII) for at least 6 months, to study and describe the efficacy and safety of the predictive low glucose suspend (PLGS) system in real life, in difficult diabetes (severe hypoglycemia, unawared hypoglycemia, brittle diabetes).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
HbA1c	month 0, 3, 6, 9, 12

Other Outcome Measures

Outcome Measure	Time Frame
daily insulin total dose	month 0, 3, 6, 9, 12
basal / bolus ratio	month 0, 3, 6, 9, 12
daily bolus number	month 0, 3, 6, 9, 12
Mean daily hypoglycemic predictive-stop time	month 0, 3, 6, 9, 12
Mean daily hypoglycemic-stop time	month 0, 3, 6, 9, 12
Time Percentage with CGM Sensor Use Time	month 0, 3, 6, 9, 12
Medical time at each consultation	month 0, 3, 6, 9, 12

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Michael JOUBERT, MD, University Hospital, Caen

Publications and helpful links

General Publications

• Joubert M, Briant AR, Kessler L, Fall-Mostaine F, Dubois S, Guerci B, Schoumacker-Ley L, Reznik Y, Parienti JJ. Sensor-Augmented Insulin Pump with Predictive Low-Glucose Suspend (PLGS): Determining Optimal Settings of Pump and Sensor in a Multicenter Cohort of Patients with Type 1 Diabetes. Diabetes Ther. 2022 Sep;13(9):1645-1657. doi: 10.1007/s13300-022-01302-3. Epub 2022 Aug 1.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimated): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: insulin pump; predictive low glucose suspend; continuous glucose monitoring sensor
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 16-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO