We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03195140
First Posted: June 22, 2017
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Jaeb Center for Health Research
Information provided by (Responsible Party):
Tandem Diabetes Care, Inc.
  Purpose
A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth > 6 years old with type 1 diabetes (T1D).

Condition Intervention
Diabetes Mellitus, Type 1 Device: Predictive Low Glucose Suspend

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tandem Diabetes Care, Inc.:

Primary Outcome Measures:
  • Sensor Glucose Values [ Time Frame: 3 weeks ]
    Percentage of sensor glucose values <70 mg/dL


Secondary Outcome Measures:
  • Hypoglycemia <60 mg/dL [ Time Frame: 3 weeks ]
    Percentage of values <60 mg/dL

  • Hypoglycemia <50 mg/dL [ Time Frame: 3 weeks ]
    Percentage of values <50 mg/dL

  • Hypoglycemia AUC <70 mg/dL [ Time Frame: 3 weeks ]
    Area Under Curve (AUC) <70 mg/dL

  • Hypoglycemia index [ Time Frame: 3 weeks ]
    Low blood glucose index

  • Hypoglycemic events [ Time Frame: 3 weeks ]
    Frequency of CGM-measured hypoglycemic events

  • Glucose Control [ Time Frame: 3 weeks ]
    Mean glucose; Percentage of values 70 to 180 mg/dL

  • Hyperglycemia >250 mg/dL [ Time Frame: 3 weeks ]
    Percentage of values >250 mg/dL

  • Hyperglycemia >180 mg/dL [ Time Frame: 3 weeks ]
    Percentage of values >180 mg/dL

  • Hyperglycemia AUC >180 mg/dL [ Time Frame: 3 weeks ]
    AUC glucose >180 mg/dL

  • Hyperglycemia index [ Time Frame: 3 weeks ]
    High blood glucose index


Enrollment: 107
Actual Study Start Date: August 11, 2017
Estimated Study Completion Date: January 15, 2018
Estimated Primary Completion Date: January 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Arm
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.
Device: Predictive Low Glucose Suspend
Application of Predictive Low Glucose Suspend
No Intervention: Control Arm
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.

Detailed Description:
  1. 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
  2. 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.

    1. 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.
    2. 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.

    i. The Tandem SAP pump will be used during the SAP Training Period and pump training will be customized based on prior pump experience

  3. 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.
  4. 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195140


Locations
United States, California
Stanford University
Palo Alto, California, United States, 94304
William Sansum Diabetes Center
Santa Barbara, California, United States, 93105
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Tandem Diabetes Care, Inc.
Jaeb Center for Health Research
Investigators
Principal Investigator: Bruce Buckingham, MD Stanford University
Study Chair: Vance Swanson Tandem Diabetes Care, Inc.
Study Director: John Lum, MS JCHR
  More Information

Responsible Party: Tandem Diabetes Care, Inc.
ClinicalTrials.gov Identifier: NCT03195140     History of Changes
Other Study ID Numbers: G170105
First Submitted: June 14, 2017
First Posted: June 22, 2017
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Tandem Diabetes Care, Inc.:
Diabetes Mellitus
Diabetes
Sensor Augmented Pump
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases