Clinical trial NCT03047486: Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes
Official title: Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus Maturity Onset
Keywords: insulin pump
continuous glucose monitoring sensor
predictive low glucose suspend
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


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

Primary outcomes:
measure: Glucose TIR (time in range) from CGM recording
timeFrame: change between baseline and after 12 month
measure: Glucose Time below range (hypoglycemia < 70 mg/dl) from CGM recording
timeFrame: change between baseline and after 12 month
Secondary outcomes:
measure: HbA1c
timeFrame: month 0, 3, 6, 9, 12
Other outcomes:
measure: daily insulin total dose
timeFrame: month 0, 3, 6, 9, 12
measure: basal / bolus ratio
timeFrame: month 0, 3, 6, 9, 12
measure: daily bolus number
timeFrame: month 0, 3, 6, 9, 12
measure: Mean daily hypoglycemic predictive-stop time
timeFrame: month 0, 3, 6, 9, 12
measure: Mean daily hypoglycemic-stop time
timeFrame: month 0, 3, 6, 9, 12
measure: Time Percentage with CGM Sensor Use Time
timeFrame: month 0, 3, 6, 9, 12
measure: Medical time at each consultation
timeFrame: month 0, 3, 6, 9, 12
Locations:
city: Caen
country: France
facility: Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
Study officials:
affiliation: University Hospital, Caen
name: Michael JOUBERT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.