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Completed

NCT Number: NCT03047486

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Caen, 14000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Glucose TIR (time in range) from CGM recording

    Time frame: change between baseline and after 12 month

    TIR will be calculated from the CGM recording, thanks to the medtronic carelink software

  2. Glucose Time below range (hypoglycemia < 70 mg/dl) from CGM recording

    Time frame: change between baseline and after 12 month

    Time below range will be calculated from the CGM recording, thanks to the medtronic carelink software

Secondary outcomes

  1. HbA1c

    Time frame: month 0, 3, 6, 9, 12

Other outcomes

  1. daily insulin total dose

    Time frame: month 0, 3, 6, 9, 12

  2. basal / bolus ratio

    Time frame: month 0, 3, 6, 9, 12

  3. daily bolus number

    Time frame: month 0, 3, 6, 9, 12

  4. Mean daily hypoglycemic predictive-stop time

    Time frame: month 0, 3, 6, 9, 12

  5. Mean daily hypoglycemic-stop time

    Time frame: month 0, 3, 6, 9, 12

  6. Time Percentage with CGM Sensor Use Time

    Time frame: month 0, 3, 6, 9, 12

  7. Medical time at each consultation

    Time frame: month 0, 3, 6, 9, 12

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: Smartguard

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2017
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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