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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MiniMed™640G and Suspend before low
MiniMed™640G
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

24 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Besançon
  • CHU Grenoble
  • APHM - La Conception
  • CHU Montpellier - Hôpital Lapeyronie
  • Ospedale Papa Giovanni XXIII
  • Ospedale S. Raffaele
  • Ospedale S. Gionanni di Dio
  • Groene Hart Ziekenhuis
  • Maasstad Ziekenhuis
  • UMC Utrecht
  • Isala
  • Harrogate District Hospital
  • King's College London
  • Manchester Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Control

Arm Description

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

MiniMed™640G alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.
Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.

Full Information

First Posted
March 29, 2016
Last Updated
January 10, 2020
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT02733991
Brief Title
Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes
Acronym
SMILE
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
MiniMed™640G alone
Intervention Type
Device
Intervention Name(s)
MiniMed™640G and Suspend before low
Other Intervention Name(s)
MiniMed™640G and SmartGuard™, MiniMed™640G and Predictive Low Glucose Management
Intervention Description
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
Intervention Name(s)
MiniMed™640G
Intervention Description
Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks.
Primary Outcome Measure Information:
Title
Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.
Time Frame
6 months
Title
Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
Country
France
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Name
APHM - La Conception
City
Marseille
Country
France
Facility Name
CHU Montpellier - Hôpital Lapeyronie
City
Montpellier
Country
France
Facility Name
Ospedale Papa Giovanni XXIII
City
Bergamo
Country
Italy
Facility Name
Ospedale S. Raffaele
City
Milan
Country
Italy
Facility Name
Ospedale S. Gionanni di Dio
City
Olbia
Country
Italy
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Isala
City
Zwolle
Country
Netherlands
Facility Name
Harrogate District Hospital
City
Harrogate
State/Province
N. Yorkshire
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 9NU
Country
United Kingdom
Facility Name
Manchester Diabetes Center
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32412858
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.
Results Reference
derived
PubMed Identifier
31047902
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.
Results Reference
derived

Learn more about this trial

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

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