Type 1 DiabetesSMILENCT02733991

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

A study testing MiniMed™640G and Suspend before low and MiniMed™640G in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 14 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 24 to 75 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: MiniMed™640G and Suspend before low and MiniMed™640G
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 14 sitesin 4 countries
Study dates: Dec 2016to Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 24 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Show all 15Show fewer

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.

Trial locations and contacts

14 sites in 4 countries.

Country

City, postcode or hospital

14 sites in 4 countries

France4 sites

CHU de Besançon
Besançon
CHU Grenoble
Grenoble
APHM - La Conception
Marseille
CHU Montpellier - Hôpital Lapeyronie
Montpellier

Other trials in France

Netherlands4 sites

Groene Hart Ziekenhuis
Gouda
Maasstad Ziekenhuis
Rotterdam
UMC Utrecht
Utrecht
Isala
Zwolle

Other trials in Netherlands

Italy3 sites

Ospedale Papa Giovanni XXIII
Bergamo
Ospedale S. Raffaele
Milan
Ospedale S. Gionanni di Dio
Olbia

Other trials in Italy

United Kingdom3 sites

Harrogate District Hospital
Harrogate, N. Yorkshire, HG2 7SX
King's College London
London, SE5 9NU
Manchester Diabetes Center
Manchester

Other trials in United Kingdom

About this study

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
Being tested: MiniMed™640G and Suspend before low, MiniMed™640G
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MiniMed™640G and Suspend before lowDevice
Also called MiniMed™640G and SmartGuard™, MiniMed™640G and Predictive Low Glucose Management
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.
MiniMed™640GDevice
Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks.

Study groups in NCT02733991
Study group	Role	What they receive
Treatment	Experimental	MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on. Receives: Device: MiniMed™640G and Suspend before low
Control	Active comparator	MiniMed™640G alone Receives: Device: MiniMed™640G

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.
Measured: 6 months

Secondary outcomes (2)

Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.
Measured: 6 months
Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2016Oct 2018

First posted12 Apr 2016 (estimated)
Study startDec 2016
Primary completionOct 2018
Study completionOct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02733991
Sponsor's protocol ID: CEP311
Acronym: SMILE
Status last verified: Jan 2020
First submitted: 29 Mar 2016
Last updated: 21 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 32412858
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.
PubMed 31047902

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes
ClinicalTrials.gov ID: NCT02733991
Acronym / sponsor ID: SMILE / CEP311
Conditions: Type 1 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2016 (actual)
Primary completion: Oct 2018 (actual)
Study completion: Oct 2018 (actual)
First posted: 12 Apr 2016 (estimated)
Results: Posted 6 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Device: MiniMed™640G and Suspend before lowMiniMed™640G and Suspend before Low feature of SmartGuard™ turned on.
Control	Active comparator	Device: MiniMed™640GMiniMed™640G alone

Who may qualify

Ages: 24 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MiniMed™640G and Suspend before lowAlso: MiniMed™640G and SmartGuard™, MiniMed™640G and Predictive Low Glucose ManagementAll 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.	Device	Treatment
MiniMed™640GControl Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks.	Device	Control

Primary outcome

Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.
Time frame: 6 months

2 secondary outcomes

Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.
Time frame: 6 months
Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.
Time frame: 6 months

Results and safety

Results posted to the registry on 6 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	76	75
Control	77	72

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

Time frame: 6 months. Mean (Standard Deviation). Unit: hypoglycaemic events per week

Measure	Treatment n = 76	Control n = 75
Value	1.12 (1.229)	4.13 (3.361)

Treatment vs Control: Mean Difference (Final Values): -2.88 (95% CI -3.51 to -2.25), p <0.0001, Mixed Models Analysis

Population analysed: 2 participants in the control arm did not have data.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	6 of 76 (7.9%)	36 of 76 (47.4%)	0 of 76
Control	1 of 77 (1.3%)	37 of 77 (48.1%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32412858Habteab 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.
Derived from this study: PubMed 31047902Bosi 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.
Individual participant dataSharing planned: No

Related trials for Type 1 Diabetes

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MiniMed™640G and Suspend before low and MiniMed™640G in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 14 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France, Netherlands, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02733991, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.