NCT03195140

Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Tandem Diabetes Care, Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Predictive Low Glucose Suspend	Application of Predictive Low Glucose Suspend

Timeline

• Start date: 2017-08-11
• Primary completion: 2018-02-06
• Completion: 2018-02-06
• First posted: 2017-06-22
• Last updated: 2023-12-08
• Results posted: 2023-12-08

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study