SGLT2 Inhibitor Adjunctive Therapy to Closed Loop Control in Type 1 Diabetes Mellitus

Summary

The primary purpose of this study is to evaluate the safety and efficacy of combining SGLT2 inhibitors with closed loop control (CLC).

Conditions

• Type 1 Diabetes

Interventions

COMBINATION_PRODUCT

Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks

Participants with be provided with Empagliflozin to take daily for approximately 10 weeks. Along with the study medication, participants will initially use the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks.

COMBINATION_PRODUCT

Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks

Participants with be provided with Empagliflozin to take daily for approximately 10 weeks. Along with the study medication, participants will initially use the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks.

DEVICE

No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks

Participants will initially use the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks. Empaglizflozin will not be provided to this group.

DEVICE

No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks

Participants will initially use the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks. Empaglizflozin will not be provided to this group.

Sponsors & Collaborators

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

  collaborator NIH

• Tandem Diabetes Care, Inc.

  collaborator INDUSTRY

• DexCom, Inc.

  collaborator INDUSTRY

• Ananda Basu, MD

  lead OTHER

Principal Investigators

• Ananda Basu, MD · University of Virginia

• Ralf Nass, MD · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-24

Primary Completion

2021-09-07

Completion

2021-09-07

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations