CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 82 enrolled
Drug / intervention
Tandem t:slim X2 with HCL or PLGSdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04016662
NCT04016662Phase 4Completed
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A Randomized Cross-over Trial Evaluating Automated Insulin Delivery Technologies on Hypoglycemia and Quality of Life in Elderly Adults With Type 1 Diabetes

Jaeb Center for Health Research·interventional·Posted Jul 11, 2019·Updated Jan 15, 2025

In Brief

A Phase 4 clinical trial evaluating Tandem t:slim X2 with HCL or PLGS for Type 1 Diabetes Mellitus. Completed, enrolled 82 participants across 4 sites.

Detailed Summary

A multi-center, randomized, crossover trial consisting of three sequential 12-week periods, with the HCL feature used during one period, the PLGS feature used during one period and SAP therapy (control) during one period. The crossover trial will be preceded by a run-in phase in which participants will receive training using the study devices (Dexcom G6 and Tandem t:slim X2 pump). After the last crossover period, participants will be given the opportunity to use study devices for an additional 12 weeks to assess preference of system use (PLGS, HCL or SAP) and associated characteristics, durability and safety in a more real-world setting with less frequent study contact.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc., Tandem Diabetes Care, Inc., University of Minnesota - Advanced Research and Diagnostic Laboratory, Mayo Clinic, University of Pennsylvania, AdventHealth Diabetes Institute, Washington State University

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJul 11, 2019
Enrollment StartSep 28, 2020
Primary CompletionSep 14, 2023
Study CompletionJan 5, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.0 years ago

Interventions

Tandem t:slim X2 with HCL or PLGSdevice

The system components include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6. The modular control algorithm has a safety supervision module that limits insulin delivery to prevent hypoglycemia at all times. The algorithm gradually decreases hyperglycemia from bedtime to reach a target of 120 mg/dL by waking time. During awake hours, the control algorithm attempts to maintain glucose within a target range (112.5 to 160 mg/dL) with meal time insulin boluses delivered based on usual bolus procedures undertaken by patients on an insulin pump (Hybrid closed loop). The system components include the t:slim X2 with with Basal-IQ Technology and the Dexcom CGM G6. The PLGS System is able to stop and resume basal insulin delivery automatically in response to predicted or low sensor glucose values, thereby reducing the incidence and duration of hypoglycemic episodes. The pump includes the hypoglycemia minimization strategy that will issue insulin delivery commands.