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

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

February 24, 2020

Primary Completion Date

September 7, 2021

Study Completion Date

September 7, 2021

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.

Trial Locations (1)

22903

University of Virginia, Center for Diabetes Technology, Charlottesville

All Listed Sponsors
collaborator

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

NIH

collaborator

Tandem Diabetes Care, Inc.

INDUSTRY

collaborator

DexCom, Inc.

INDUSTRY

lead

Ananda Basu, MD

OTHER

NCT04201496 - SGLT2 Inhibitor Adjunctive Therapy to Closed Loop Control in Type 1 Diabetes Mellitus | Biotech Hunter | Biotech Hunter