Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes

NCT ID: NCT02733991

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-10-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on.

Group Type: EXPERIMENTAL

MiniMed™640G and Suspend before low

Intervention Type: DEVICE

All enrolled subjects will start a run in phase, receive training and start pump therapy with the MiniMed™640G insulin pump and usage of blinded Continuous Glucose Monitoring. Eligible subjects that meet the randomization criteria assessed after the running phase will be randomized into the treatment or control arm. Treatment Arm: training and start of Sensor Augmented Pump therapy with Suspend before Low feature of SmartGuard turned ON.

Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks during the treatment phase.

Control

MiniMed™640G alone

Group Type: ACTIVE_COMPARATOR

MiniMed™640G

Intervention Type: DEVICE

Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks.

Interventions

MiniMed™640G and Suspend before low

All enrolled subjects will start a run in phase, receive training and start pump therapy with the MiniMed™640G insulin pump and usage of blinded Continuous Glucose Monitoring. Eligible subjects that meet the randomization criteria assessed after the running phase will be randomized into the treatment or control arm. Treatment Arm: training and start of Sensor Augmented Pump therapy with Suspend before Low feature of SmartGuard turned ON.

Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks during the treatment phase.

Intervention Type: DEVICE

MiniMed™640G

Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks.

Intervention Type: DEVICE

Other Intervention Names

MiniMed™640G and SmartGuard™; MiniMed™640G and Predictive Low Glucose Management

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.

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Besançon

Besançon, , France

CHU Grenoble

Grenoble, , France

APHM - La Conception

Marseille, , France

CHU Montpellier - Hôpital Lapeyronie

Montpellier, , France

Ospedale Papa Giovanni XXIII

Bergamo, , Italy

Ospedale S. Raffaele

Milan, , Italy

Ospedale S. Gionanni di Dio

Olbia, , Italy

Groene Hart Ziekenhuis

Gouda, , Netherlands

Maasstad Ziekenhuis

Rotterdam, , Netherlands

UMC Utrecht

Utrecht, , Netherlands

Isala

Zwolle, , Netherlands

Harrogate District Hospital

Harrogate, N. Yorkshire, United Kingdom

King's College London

London, , United Kingdom

Manchester Diabetes Center

Manchester, , United Kingdom

Countries

France; Italy; Netherlands; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32412858 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31047902 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CEP311

Identifier Type: -

Identifier Source: org_study_id