Diabetes Mellitus, Type 1NCT03195140
Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial
A study testing Predictive Low Glucose Suspend in people with Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 4 sites in United States.
Trial summary
A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth > 6 years old with type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Predictive Low Glucose Suspend
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Aug 2017to 6 Feb 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Clinical diagnosis, based on investigator assessment, of T1D treated with insulin via an insulin pump or injections for at least 1 year, with no major change in the intensity of insulin therapy in the past 3 months (e.g. switching from injections to pump)
- 2. Age ≥6.0 years old
- 3. For participants <18 years old, living with one or more parents or guardians committed to participating in training and able to contact the participant in case of an emergency
- 4. For females, not currently known to be pregnant
- - If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- 5. Investigator has confidence that the participant can successfully use all study devices and is capable of adhering to the protocol
Who cannot join
- 1. Anticipated need to use acetaminophen during study participation
- 2. Participation in another pharmaceutical or device trial at the time of enrollment or plan to participate in another study during the time period of participation in this study
- 3. Employed by, or having immediate family members employed by Tandem; or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
- 4. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk including any contraindication to the use of any of the study devices per FDA labelling
- - Individuals should not be enrolled with uncontrolled thyroid disease, renal failure (e.g., dialysis or estimated glomerular filtration (eGFR) <30), hemophilia or another major bleeding disorder, or unstable cardiovascular disease.
- - Laboratory testing and other work up needed to determine that an individual is a suitable candidate for the study should be performed as part of usual care.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Barbara Davis Center
Aurora, Colorado, 80045
Yale University
New Haven, Connecticut, 06520
Stanford University
Palo Alto, California, 94304
William Sansum Diabetes Center
Santa Barbara, California, 93105
About this study
Official title: Tandem PLGS Pivotal Trial: A Randomized Clinical Trial to Assess the Efficacy of Predictive Low Glucose Suspend Versus Sensor-augmented Pump Therapy in the Management of Type 1 Diabetes
A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth > 6 years old with type 1 diabetes (T1D).
Read the detailed description
- Screening and Enrollment
- Informed consent will be signed and eligibility will be assessed
- History and physical examination
- HbA1c measurement
- Urine or serum pregnancy test (if applicable)
- Evaluation of Continuous Glucose Monitoring (CGM) and pump experience
- CGM and (Sensor Augmented Pump) SAP Training Period at Home All eligible participants will be assessed based on their CGM and pump experience to determine if the CGM Training Period, the SAP Training Period, or both are required.
- CGM Training Period (10-14 days): Participants currently using a CGM may skip the CGM Training Period per investigator discretion, generally requiring that CGM has been used on at least 85% of days during the prior 4 weeks.
- SAP Training Period (14-28 days): Participants currently using a Tandem pump concomitantly with a Dexcom CGM may skip both the CGM Training and the SAP Training periods per investigator discretion.
- The Tandem SAP pump will be used during the SAP Training Period and pump training will be customized based on prior pump experience
- PLGS Pilot Phase Prior to the initiation of the crossover trial, 10 adult participants will use the Tandem PLGS pump and CGM system in a 10-day Pilot Period. Data will be evaluated for system usability and predetermined safety metrics before participants ≥12 years old can be randomized into the crossover trial.
- Randomized Crossover Trial The crossover trial will begin after the data from the Pilot Period have been reviewed. Enrollment of participants 6 to 11 years old will be deferred until data from 100 post-randomization PLGS participant-days have been evaluated from participants 12 to 17 years old and the same predetermined safety metrics used to evaluate the Pilot Period have been satisfied.
At the Crossover Trial initiation visit, the following will be done:
- The clinician will confirm the participant's willingness to participate in the crossover trial
- The participant's HbA1c level will be measured
- Random assignment to Group A or Group B Group A: intervention period first (PLGS), control period second (SAP) Group B: control period first (SAP), intervention period second (PLGS)
During each of the two 3-week periods, a phone, email, or text contact will occur at 2 and 14 days, and a clinic visit at 7 and 21 days. HbA1c will be measured at the end of each period.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Predictive Low Glucose Suspend
- Keywords
- Diabetes Mellitus, Diabetes, Sensor Augmented Pump, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predictive Low Glucose SuspendDevice
Application of Predictive Low Glucose Suspend
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. Receives: Device: Predictive Low Glucose Suspend |
| Control Arm | No intervention | The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia < 70 mg/dL
Percentage of time CGM <70 mg/dL
Measured: 3 weeks
Secondary outcomes (10)
Hypoglycemia <60 mg/dL
Percentage of time CGM <60 mg/dL
Measured: 3 weeks
Hypoglycemia <50 mg/dL
Percentage of time CGM <50 mg/dL
Measured: 3 weeks
Hypoglycemia AOC <70 mg/dL
Area Over Curve (AOC) <70 mg/dL
Measured: 3 weeks
Low Blood Glucose Index (LBGI)
Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 < LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 < LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI > 5.0 is associated with high risk of hypoglycemia.
Measured: 3 weeks
Hypoglycemic Events Per Week
A hypoglycemia event was defined as at least two sensor values <54 mg/dL that were ≥15 min apart with no intervening values >54 mg/dL. At least two sensor values >70 mg/dL that are ≥30 min apart with no intervening values <70 mg/dL are required to end a hypoglycemic event.
Measured: 3 weeks
Time in Range 70-180 mg/dL
Percentage of time CGM in range 70 to 180 mg/dL
Measured: 3 weeks
Hyperglycemia >250 mg/dL
Percentage of time CGM >250 mg/dL
Measured: 3 weeks
Hyperglycemia >180 mg/dL
Percentage of time CGM >180 mg/dL
Measured: 3 weeks
Area Under Curve >180 mg/dL
Hyperglycemia Area Under Curve of CGM >180 mg/dL
Measured: 3 weeks
High Blood Glucose Index (HBGI)
High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start11 Aug 2017
- Primary completion6 Feb 2018
- Study completion6 Feb 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 (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Crossover
- Model description
- Multi-center, randomized, crossover design, consisting of two 3-week periods, with the PLGS System used during one period and SAP therapy used during the other period. The crossover trial will be preceded by a run-in phase in which participants may receive training using the study devices. For 10 adult participants, a PLGS Pilot Period will proceed to the crossover trial to ensure safety and usability objectives are met prior to the start of the crossover trial.
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tandem Diabetes Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Sponsor
- Investigators
- Bruce Buckingham, MD, Principal investigator, Stanford UniversityVance Swanson, Study chair, Tandem Diabetes Care, Inc.John Lum, MS, Study director, JCHR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195140
- Sponsor's protocol ID
- G170105
- Status last verified
- Dec 2023
- First submitted
- 14 Jun 2017
- Last updated
- 8 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Forlenza GP, Li Z, Buckingham BA, Pinsker JE, Cengiz E, Wadwa RP, Ekhlaspour L, Church MM, Weinzimer SA, Jost E, Marcal T, Andre C, Carria L, Swanson V, Lum JW, Kollman C, Woodall W, Beck RW. Predictive Low-Glucose Suspend Reduces Hypoglycemia in Adults, Adolescents, and Children With Type 1 Diabetes in an At-Home Randomized Crossover Study: Results of the PROLOG Trial. Diabetes Care. 2018 Oct;41(10):2155-2161. doi: 10.2337/dc18-0771. Epub 2018 Aug 8.
PubMed 30089663
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tandem PLGS Pivotal Trial: A Randomized Clinical Trial to Assess the Efficacy of Predictive Low Glucose Suspend Versus Sensor-augmented Pump Therapy in the Management of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03195140
- Acronym / sponsor ID
- G170105
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Diabetes, Sensor Augmented Pump, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Tandem Diabetes Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Posted 8 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth > 6 years old with type 1 diabetes (T1D).
Detailed description
- Screening and Enrollment
- Informed consent will be signed and eligibility will be assessed
- History and physical examination
- HbA1c measurement
- Urine or serum pregnancy test (if applicable)
- Evaluation of Continuous Glucose Monitoring (CGM) and pump experience
- CGM and (Sensor Augmented Pump) SAP Training Period at Home All eligible participants will be assessed based on their CGM and pump experience to determine if the CGM Training Period, the SAP Training Period, or both are required.
- CGM Training Period (10-14 days): Participants currently using a CGM may skip the CGM Training Period per investigator discretion, generally requiring that CGM has been used on at least 85% of days during the prior 4 weeks.
- SAP Training Period (14-28 days): Participants currently using a Tandem pump concomitantly with a Dexcom CGM may skip both the CGM Training and the SAP Training periods per investigator discretion.
- The Tandem SAP pump will be used during the SAP Training Period and pump training will be customized based on prior pump experience
- PLGS Pilot Phase Prior to the initiation of the crossover trial, 10 adult participants will use the Tandem PLGS pump and CGM system in a 10-day Pilot Period. Data will be evaluated for system usability and predetermined safety metrics before participants ≥12 years old can be randomized into the crossover trial.
- Randomized Crossover Trial The crossover trial will begin after the data from the Pilot Period have been reviewed. Enrollment of participants 6 to 11 years old will be deferred until data from 100 post-randomization PLGS participant-days have been evaluated from participants 12 to 17 years old and the same predetermined safety metrics used to evaluate the Pilot Period have been satisfied.
At the Crossover Trial initiation visit, the following will be done:
- The clinician will confirm the participant's willingness to participate in the crossover trial
- The participant's HbA1c level will be measured
- Random assignment to Group A or Group B Group A: intervention period first (PLGS), control period second (SAP) Group B: control period first (SAP), intervention period second (PLGS)
During each of the two 3-week periods, a phone, email, or text contact will occur at 2 and 14 days, and a clinic visit at 7 and 21 days. HbA1c will be measured at the end of each period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center, randomized, crossover design, consisting of two 3-week periods, with the PLGS System used during one period and SAP therapy used during the other period. The crossover trial will be preceded by a run-in phase in which participants may receive training using the study devices. For 10 adult participants, a PLGS Pilot Period will proceed to the crossover trial to ensure safety and usability objectives are met prior to the start of the crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Predictive Low Glucose SuspendThe intervention arm (use of PLGS feature) will utilize Tandem Diabetes Care's ambulatory insulin infusion pump with integrated Dexcom G5 CGM and predictive low glucose suspend function. This pump is called the "t:slim X2 with Basal-IQ Technology" and is referred to in the protocol as the Tandem PLGS pump. |
| Control Arm | No intervention | –The control arm (SAP only) will utilize an identical pump in functionality as the Tandem PLGS pump except for the lack of the PLGS feature and the associated user interface. This pump is called the t:slim X2 Dexcom G5 Mobile CGM Enabled pump, and is referred to in the protocol as the Tandem SAP pump. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Clinical diagnosis, based on investigator assessment, of T1D treated with insulin via an insulin pump or injections for at least 1 year, with no major change in the intensity of insulin therapy in the past 3 months (e.g. switching from injections to pump)
- 2. Age ≥6.0 years old
- 3. For participants <18 years old, living with one or more parents or guardians committed to participating in training and able to contact the participant in case of an emergency
- 4. For females, not currently known to be pregnant
- - If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
Key exclusion criteria (6 listed)
- 1. Anticipated need to use acetaminophen during study participation
- 2. Participation in another pharmaceutical or device trial at the time of enrollment or plan to participate in another study during the time period of participation in this study
- 3. Employed by, or having immediate family members employed by Tandem; or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
- 4. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk including any contraindication to the use of any of the study devices per FDA labelling
- - Individuals should not be enrolled with uncontrolled thyroid disease, renal failure (e.g., dialysis or estimated glomerular filtration (eGFR) <30), hemophilia or another major bleeding disorder, or unstable cardiovascular disease.
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 SuspendApplication of Predictive Low Glucose Suspend | Device | Intervention Arm |
Primary outcome
Hypoglycemia < 70 mg/dL
Time frame: 3 weeks
Percentage of time CGM <70 mg/dL
10 secondary outcomes
Hypoglycemia <60 mg/dL
Time frame: 3 weeks
Hypoglycemia <50 mg/dL
Time frame: 3 weeks
Hypoglycemia AOC <70 mg/dL
Time frame: 3 weeks
Low Blood Glucose Index (LBGI)
Time frame: 3 weeks
Hypoglycemic Events Per Week
Time frame: 3 weeks
Time in Range 70-180 mg/dL
Time frame: 3 weeks
Hyperglycemia >250 mg/dL
Time frame: 3 weeks
Hyperglycemia >180 mg/dL
Time frame: 3 weeks
Area Under Curve >180 mg/dL
Time frame: 3 weeks
High Blood Glucose Index (HBGI)
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30089663Forlenza GP, Li Z, Buckingham BA, Pinsker JE, Cengiz E, Wadwa RP, Ekhlaspour L, Church MM, Weinzimer SA, Jost E, Marcal T, Andre C, Carria L, Swanson V, Lum JW, Kollman C, Woodall W, Beck RW. Predictive Low-Glucose Suspend Reduces Hypoglycemia in Adults, Adolescents, and Children With Type 1 Diabetes in an At-Home Randomized Crossover Study: Results of the PROLOG Trial. Diabetes Care. 2018 Oct;41(10):2155-2161. doi: 10.2337/dc18-0771. Epub 2018 Aug 8.
- Individual participant dataSharing planned: No
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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.
Bruce Buckingham, MD principal investigator
Stanford University
Vance Swanson study chair
Tandem Diabetes Care, Inc.
John Lum, MS study director
JCHR
4 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 Suspend in people with Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 4 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 6 inclusion and 6 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 8 Dec 2023). 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?
Hypoglycemia < 70 mg/dL (time frame: 3 weeks). 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 NCT03195140, 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 8 Dec 2023.