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

NCT ID: NCT03047486

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-01-01

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.

Conditions

Type 1 Diabetes Mellitus Maturity Onset

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael JOUBERT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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

Caen, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35913656 (View on PubMed)

Other Identifiers

16-106

Identifier Type: -

Identifier Source: org_study_id