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

NCT02733991 | Completed Results DMC FDA Device

• 1 other identifier: CEP311
• Study Type: interventional
• Target: 153
• Locations: 4 countries
• Sites: 14

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

Outcome Measures

Primary Outcomes (1)

• Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.

  6 months

Secondary Outcomes (2)

• Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.

  6 months

• Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.

  6 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Device: MiniMed™640G and Suspend before low

Control

ACTIVE COMPARATOR

MiniMed™640G alone

Device: MiniMed™640G

Interventions

MiniMed™640G and Suspend before low 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.

Also known as: MiniMed™640G and SmartGuard™, MiniMed™640G and Predictive Low Glucose Management

Treatment

MiniMed™640G DEVICE

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

Control

Eligibility Criteria

• Age: 24 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (14)

CHU de Besançon

Besançon, France

Location

CHU Grenoble

Grenoble, France

Location

APHM - La Conception

Marseille, France

Location

CHU Montpellier - Hôpital Lapeyronie

Montpellier, France

Location

Ospedale Papa Giovanni XXIII

Bergamo, Italy

Location

Ospedale S. Raffaele

Milan, Italy

Location

Ospedale S. Gionanni di Dio

Olbia, Italy

Location

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Isala

Zwolle, Netherlands

Location

Harrogate District Hospital

Harrogate, N. Yorkshire, HG2 7SX, United Kingdom

Location

King's College London

London, SE5 9NU, United Kingdom

Location

Manchester Diabetes Center

Manchester, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 32412858 DERIVED

• 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.

  PMID: 31047902 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Ohad Cohen M.D., Medical Affairs Director
• Organization: Medtronic Diabetes EMEA

ohad.cohen@medtronic.com

+972 54 321 1108

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 12, 2016
• Study Start: December 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 21, 2020
• Results First Posted: November 6, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); FR (4); GB (3); NL (4)