Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial
|ClinicalTrials.gov Identifier: NCT03195140|
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: Predictive Low Glucose Suspend||Not Applicable|
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.
i. 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|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)|
|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|
|Actual Study Start Date :||August 11, 2017|
|Actual Primary Completion Date :||February 6, 2018|
|Actual Study Completion Date :||February 6, 2018|
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.
- Sensor Glucose Values [ Time Frame: 3 weeks ]Percentage of sensor glucose values <70 mg/dL
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195140
|United States, California|
|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|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Bruce Buckingham, MD||Stanford University|
|Study Chair:||Vance Swanson||Tandem Diabetes Care, Inc.|
|Study Director:||John Lum, MS||JCHR|