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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Ananda Basu, MD
Study ID
NCT04201496
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks — COMBINATION_PRODUCT
    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.
  • Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks — COMBINATION_PRODUCT
    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.
  • No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks — DEVICE
    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.
  • No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks — DEVICE
    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.

Study Details

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

Key Dates

Start date
Feb 24, 2020
Status verified
Aug 2022
Primary completion
Sep 7, 2021
Completion
Sep 7, 2021

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks
    Control-IQ x 4 weeks (CiQ-EMPA) then Basal-IQ x 2 weeks (BiQ-EMPA)
  • Experimental: Empagliflozin + Basal-IQ x 2 wks then CiQ x 4 wks
    Basal-IQ x 2 weeks (BiQ-EMPA) then Control-IQ x 4 weeks (CiQ-EMPA)
  • Active Comparator: No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks
    Control-IQ x 4 weeks (CiQ-NO EMPA) then Basal-IQ x 2 weeks (BiQ-NO EMPA)
  • Active Comparator: No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks
    Basal-IQ x 2 weeks (BiQ-NO EMPA) then Control-IQ x 4 weeks (CiQ-NO EMPA)

Primary Outcome Measure

CGM-measured time in the target range 70-180mg/dl (TIR) during the day [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia, Center for Diabetes TechnologyCharlottesvilleVirginia22903-

Find similar trials in Charlottesville, VA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Virginia, Center for Diabetes Technology· Charlottesville, VA

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