Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

DEVICE

Tandem t:slim X2 with HCL or PLGS

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• DexCom, Inc.

  collaborator INDUSTRY

• Tandem Diabetes Care, Inc.

  collaborator INDUSTRY

• University of Minnesota - Advanced Research and Diagnostic Laboratory

  collaborator UNKNOWN

• Mayo Clinic

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• AdventHealth Diabetes Institute

  collaborator UNKNOWN

• Washington State University

  collaborator OTHER

• Jaeb Center for Health Research

  lead OTHER

Principal Investigators

• Robert Henderson, MS · Jaeb Center for Health Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-28

Primary Completion

2023-09-14

Completion

2024-01-05

FDA Device

Yes

Countries

• United States

Study Locations