Type 1 DiabetesPLGMNCT02130284
In Clinic Evaluation of the PLGM Feature
A study testing Predictive Low Glucose Management Feature in Insulin pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 8 sites in United States.
Trial summary
This study is a multi-center, single arm and in-clinic study to evaluate the safety of the PLGM System and its algorithm with the Enlite 3 Sensor. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Predictive Low Glucose Management Feature in Insulin pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2014to Sep 2015
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is 14-75 years of age at time of screening
- Subject has a clinical diagnosis of type 1 diabetes, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Inclusion Criteria that are Based on Demands of In-Clinic Study Procedures
- On pump therapy at the time of screening with insulin sensitivity and insulin carbohydrate ratio
- Adequate venous access as assessed by investigator or appropriate staff
Who cannot join
- Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- Subject has a positive urine or serum pregnancy screening test
- Subject is female, sexually active without use of contraception and plans to become pregnant during the course of the study
Show all 16Show fewer
- Subject has had a hypoglycemic induced seizure within the past 6 months prior to screening visit
- Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
- Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
- Subject has a history of a seizure disorder
- Subject has central nervous system or cardiac disorder resulting in syncope
- Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- Subjects with hematocrit (Hct) lower than the normal reference range for age per local lab testing
- Subjects with a history or findings on screening electrocardiogram (EKG) of any cardiac arrhythmia, including atrial arrhythmias
- Subjects with a history of adrenal insufficiency
- Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
University of Virgina
Charlottesville, Virginia, 22903
Barbara Davis Center of Childhood Diabetes
Denver, Colorado, 80045
AMCR Institute, Inc.
Escondido, California, 92026
Yale University Diabetes Research Program
New Haven, Connecticut, 06519
Rainier Clinical Research
Renton, Washington, 98057
Stanford University Department of Pediatric Endocrinology
Stanford, California, 94305
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: In-Clinic Evaluation of the Predictive Low Glucose Management (PLGM) System in Adult and Pediatric Insulin Requiring Patients With Diabetes Using the Enlite 3 Sensor
This study is a multi-center, single arm and in-clinic study to evaluate the safety of the PLGM System and its algorithm with the Enlite 3 Sensor.
Read the detailed description
A total of up to 95 subjects with type 1 diabetes (age 14-75 years old) will be enrolled at up to 8 investigational centers in order to reach a minimum of 60 subjects who will complete the study (N=minimum 40 adult subjects, 22-75 years old) and N=minimum 15 pediatric subjects (14-21 years old). Subjects will be evaluated in an in-clinic setting with induction of hypoglycemia by increasing their basal rate using a standardized titration tool referred to in protocol as rate of change basal increase algorithm (Buckingham, Diabetes Care 5, 2010). Total duration of frequent sample testing (FST) using Yellow Springs Instrument (YSI) may be up to 19 hours.
Subjects will undergo in-clinic testing on Sensor Day 1.
All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.
The In-Clinic part of the study consists of hypoglycemic induction and an observation period.
Hypoglycemic induction ends when one of the following 3 criteria is met, whichever comes first:
- PLGM is activated
- YSI glucose is less than or equal to 65 mg/dL, followed by the next YSI sample less than or equal to 65 mg/dL (2 contiguous YSI samples).
- Neither condition for #1 or #2 has been met in 12 hours
Observation with YSI ends when:
- If PLGM is activated, observation with YSI frequent sample testing will include the Suspend period (30 minutes minimum to 2 hours maximum) and insulin resumption period (approximately 4 hours from the time insulin delivery resumes). This may include insulin re-suspension during this period. Maximum observation with YSI frequent sample testing should be no longer than 19 hours.
- YSI glucose less than or equal to 65 mg/dL is followed by the next YSI sample less than or equal to 65 mg/dL (2 contiguous YSI samples). The subject will be rescued and YSI observation will end
- Twelve hours have passed since the start of hypoglycemic induction without PLGM activation
- See In-Clinic Stopping rules
Enrollment for this study will proceed in phases.
Phase 1 only allows enrollment of adult subjects (22-75 years). Subjects will wear pump system, as shown below:
- One Study Pump
- One GST-3C Transmitter
- One Enlite 3 Sensor
Progression to Phase 2 may occur after 10 adult subjects have completed Phase 1 and a Data Safety Monitoring Board (DSMB) has approved that it is safe to continue on to Phase 2.
Phase 2 enrollment involves a minimum of 15 pediatric subjects (14-21). Subjects will wear the same pump system as shown for Phase 1.
A total of up to 95 subjects will be enrolled at up to 10 investigational centers in order to reach a minimum of 60 subjects (N=minimum 40 adult subjects and N=minimum 15 pediatric subjects) who will complete the study.
Considering around 15% screen failure rate and approximately 15% drop-out rate, a total of up to 95 subjects will be enrolled in order to have 60 subjects complete the study.
- The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American
- Subjects will be grouped into cohorts by Age
The study is anticipated to last no longer than 12 months from investigational center initiation to completion of all data entry and monitoring procedures including final report. Subjects can expect to participate for approximately 2-3 weeks.
- Conditions
- Type 1 Diabetes
- Being tested
- Predictive Low Glucose Management Feature in Insulin pump
- 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.
Predictive Low Glucose Management Feature in Insulin pumpDevice
Also called Medtronic MiniMed 640G Insulin Pump, MMT-1512
All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| Predictive Low Glucose Management (PLGM) | Experimental | To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Receives: Device: Predictive Low Glucose Management Feature in Insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events (SAE)
Evaluation of incidence of SAE during in-clinic procedures
Measured: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Unanticipated Device Effect (UADE)
Evaluation of incidence of UADE during in-clinic procedures
Measured: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Severe Hypoglycemia
Evaluation of incidence of severe hypoglycemia during in-clinic procedures
Measured: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Diabetic Ketoacidosis
Evaluation of DKA during in-clinic procedures
Measured: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Rescue Events During In-clinic Procedues
Measured: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionSep 2015
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 (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Lee, MD, Study director, Medtronic MiniMed, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130284
- Sponsor's protocol ID
- CEP 272 PLGM
- Acronym
- PLGM
- Status last verified
- Aug 2017
- First submitted
- 18 Apr 2014
- Last updated
- 28 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Buckingham BA, Bailey TS, Christiansen M, Garg S, Weinzimer S, Bode B, Anderson SM, Brazg R, Ly TT, Kaufman FR. Evaluation of a Predictive Low-Glucose Management System In-Clinic. Diabetes Technol Ther. 2017 May;19(5):288-292. doi: 10.1089/dia.2016.0319. Epub 2017 Feb 16.
PubMed 28221823
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Clinic Evaluation of the Predictive Low Glucose Management (PLGM) System in Adult and Pediatric Insulin Requiring Patients With Diabetes Using the Enlite 3 Sensor
- ClinicalTrials.gov ID
- NCT02130284
- Acronym / sponsor ID
- PLGM / CEP 272 PLGM
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 May 2014 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-center, single arm and in-clinic study to evaluate the safety of the PLGM System and its algorithm with the Enlite 3 Sensor.
Detailed description
A total of up to 95 subjects with type 1 diabetes (age 14-75 years old) will be enrolled at up to 8 investigational centers in order to reach a minimum of 60 subjects who will complete the study (N=minimum 40 adult subjects, 22-75 years old) and N=minimum 15 pediatric subjects (14-21 years old). Subjects will be evaluated in an in-clinic setting with induction of hypoglycemia by increasing their basal rate using a standardized titration tool referred to in protocol as rate of change basal increase algorithm (Buckingham, Diabetes Care 5, 2010). Total duration of frequent sample testing (FST) using Yellow Springs Instrument (YSI) may be up to 19 hours.
Subjects will undergo in-clinic testing on Sensor Day 1.
All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.
The In-Clinic part of the study consists of hypoglycemic induction and an observation period.
Hypoglycemic induction ends when one of the following 3 criteria is met, whichever comes first:
- PLGM is activated
- YSI glucose is less than or equal to 65 mg/dL, followed by the next YSI sample less than or equal to 65 mg/dL (2 contiguous YSI samples).
- Neither condition for #1 or #2 has been met in 12 hours
Observation with YSI ends when:
- If PLGM is activated, observation with YSI frequent sample testing will include the Suspend period (30 minutes minimum to 2 hours maximum) and insulin resumption period (approximately 4 hours from the time insulin delivery resumes). This may include insulin re-suspension during this period. Maximum observation with YSI frequent sample testing should be no longer than 19 hours.
- YSI glucose less than or equal to 65 mg/dL is followed by the next YSI sample less than or equal to 65 mg/dL (2 contiguous YSI samples). The subject will be rescued and YSI observation will end
- Twelve hours have passed since the start of hypoglycemic induction without PLGM activation
- See In-Clinic Stopping rules
Enrollment for this study will proceed in phases.
Phase 1 only allows enrollment of adult subjects (22-75 years). Subjects will wear pump system, as shown below:
- One Study Pump
- One GST-3C Transmitter
- One Enlite 3 Sensor
Progression to Phase 2 may occur after 10 adult subjects have completed Phase 1 and a Data Safety Monitoring Board (DSMB) has approved that it is safe to continue on to Phase 2.
Phase 2 enrollment involves a minimum of 15 pediatric subjects (14-21). Subjects will wear the same pump system as shown for Phase 1.
A total of up to 95 subjects will be enrolled at up to 10 investigational centers in order to reach a minimum of 60 subjects (N=minimum 40 adult subjects and N=minimum 15 pediatric subjects) who will complete the study.
Considering around 15% screen failure rate and approximately 15% drop-out rate, a total of up to 95 subjects will be enrolled in order to have 60 subjects complete the study.
- The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American
- Subjects will be grouped into cohorts by Age
The study is anticipated to last no longer than 12 months from investigational center initiation to completion of all data entry and monitoring procedures including final report. Subjects can expect to participate for approximately 2-3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Predictive Low Glucose Management (PLGM) | Experimental | Device: Predictive Low Glucose Management Feature in Insulin pumpTo evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is 14-75 years of age at time of screening
- Subject has a clinical diagnosis of type 1 diabetes, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- Inclusion Criteria that are Based on Demands of In-Clinic Study Procedures
- On pump therapy at the time of screening with insulin sensitivity and insulin carbohydrate ratio
- Adequate venous access as assessed by investigator or appropriate staff
Key exclusion criteria (16 listed)
- Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- Subject has a positive urine or serum pregnancy screening test
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 |
|---|---|---|
| Predictive Low Glucose Management Feature in Insulin pumpAlso: Medtronic MiniMed 640G Insulin Pump, MMT-1512All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL. | Device | Predictive Low Glucose Management (PLGM) |
Primary outcome
Serious Adverse Events (SAE)
Time frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Evaluation of incidence of SAE during in-clinic procedures
Unanticipated Device Effect (UADE)
Time frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Evaluation of incidence of UADE during in-clinic procedures
Severe Hypoglycemia
Time frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Evaluation of incidence of severe hypoglycemia during in-clinic procedures
Diabetic Ketoacidosis
Time frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Evaluation of DKA during in-clinic procedures
Rescue Events During In-clinic Procedues
Time frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28221823Buckingham BA, Bailey TS, Christiansen M, Garg S, Weinzimer S, Bode B, Anderson SM, Brazg R, Ly TT, Kaufman FR. Evaluation of a Predictive Low-Glucose Management System In-Clinic. Diabetes Technol Ther. 2017 May;19(5):288-292. doi: 10.1089/dia.2016.0319. Epub 2017 Feb 16.
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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.
Scott Lee, MD study director
Medtronic MiniMed, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predictive Low Glucose Management Feature in Insulin pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 8 sites in United States.
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 5 inclusion and 16 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 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 4 Apr 2017). 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?
Serious Adverse Events (SAE) (time frame: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures). The study lists 5 primary outcomes in all. 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 NCT02130284, which also lists 1 linked publication.
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 28 Sep 2017.