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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).
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.
Age
6 - No limit years
Sex
ALL
Healthy Volunteers
No
Stanford University
Palo Alto, California, United States
William Sansum Diabetes Center
Santa Barbara, California, United States
Barbara Davis Center
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Start Date
August 11, 2017
Primary Completion Date
February 6, 2018
Completion Date
February 6, 2018
Last Updated
December 8, 2023
103
ACTUAL participants
Predictive Low Glucose Suspend
DEVICE
Lead Sponsor
Tandem Diabetes Care, Inc.
Collaborators
NCT04786262
NCT06748963
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06325202