Clinical trial NCT02733991: Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes
Official title: Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2016-04-12
Enrollment: 153
Sex: ALL
Minimum age (years): 24
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A premarket, international multicenter, prospective, open label, adaptive, randomized controlled study.

The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia. The primary objective is to demonstrate a reduction in the mean number of hypoglycemic events when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will aim at evaluating the difference in glycemic parameters and HbA1c.


Eligibility criteria: Inclusion Criteria:

* Age 24-75 years old at time of screening.
* Diagnosed with Type 1 diabetes ≥10 years prior to screening.
* On pump therapy for ≥ 6 months prior to screening.
* Not on Real Time continuous glucose monitoring for ≥ 3 months prior to screening.
* HbA1c value ≥5.8% and ≤10.0% as assessed by local lab ≤ 15 days prior to screening or performed at screening.
* A documented Severe Hypoglycemia event ≤ 12 months prior to screening, OR Clarke score ≥4 assessed at time of screening, OR
* Gold score ≥4 assessed at time of screening.
* Subject is willing to sign and date informed consent, comply with all study procedures and wear all study devices as required during the study.

Exclusion Criteria:

* Untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
* Subject is using Pramlintide (Symlin) SGLT2 inhibitor, GLP agonist at time of screening.
* Renal failure defined by creatinine clearance \<30 ml/min, as assessed by local lab test ≤ 3 months before screening or performed at screening at local lab.
* Hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.
* Current pregnancy or intention to conceive.
* Any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection).
* Alcohol or drug abuse, other than nicotine, per investigator judgment.
* Any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
* Legally incompetent, illiterate or vulnerable person.

Randomization Criteria:

* If subjects meet the above criteria, as well as all of the following criteria assessed at the end of the run-in period, they may continue to participate in the treatment period of the study:

  * Subject has worn two weeks the sensor with transmitter during the run-in period.
  * Subject has shown acceptable tolerance of sensor wear, per investigator judgment.
  * Subject performed ≥ 4 finger stick blood glucose measurements daily, as determined by CareLink™ Clinical data upload as the mean number of SMBG/day over the past 14 days (SMBG number / day ≥ 3.5 rounds up to 4).
  * Subject showed ability to comprehend the pump training and study procedures, per investigator judgment.

Primary outcomes:
measure: Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.
timeFrame: 6 months
Secondary outcomes:
measure: Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.
timeFrame: 6 months
measure: Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.
timeFrame: 6 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Grenoble
country: France
facility: CHU Grenoble
city: Marseille
country: France
facility: APHM - La Conception
city: Montpellier
country: France
facility: CHU Montpellier - Hôpital Lapeyronie
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII
city: Milan
country: Italy
facility: Ospedale S. Raffaele
city: Olbia
country: Italy
facility: Ospedale S. Gionanni di Dio
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Zwolle
country: Netherlands
facility: Isala
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
state: N. Yorkshire
city: London
country: United Kingdom
facility: King's College London
city: Manchester
country: United Kingdom
facility: Manchester Diabetes Center
Study officials:
References:
citation: Habteab A, Castaneda J, de Valk H, Choudhary P, Bosi E, Lablanche S, de Portu S, Da Silva J, Vorrink-de Groot L, Shin J, Cohen O. Predicting Factors Associated with Hypoglycemia Reduction with Automated Predictive Insulin Suspension in Patients at High Risk of Severe Hypoglycemia: An Analysis from the SMILE Randomized Trial. Diabetes Technol Ther. 2020 Sep;22(9):681-685. doi: 10.1089/dia.2019.0495.
citation: Bosi E, Choudhary P, de Valk HW, Lablanche S, Castaneda J, de Portu S, Da Silva J, Re R, Vorrink-de Groot L, Shin J, Kaufman FR, Cohen O; SMILE Study Group. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Jun;7(6):462-472. doi: 10.1016/S2213-8587(19)30150-0. Epub 2019 Apr 29.