SGLT2 Inhibitor Adjunctive Therapy to Closed Loop Control in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

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

Detailed description: 
      The first five participants will be enrolled in a Pilot Study to use the Basal-IQ with
      Empagliflozin 10 mg daily for approximately two weeks. These participants will participate in
      an estimated 36-48-hour hotel admission to initiate use of Closed Loop Control. The safety
      data from the Pilot Study will be presented to the Data Safety Monitoring Board (DSMB) for
      review.

      Upon DSMB approval, approximately 40 participants will be randomized 1:1 in a crossover
      design. Participants will use empagliflozin 5 mg daily. This main study is a randomized
      control trial where approximately 50 participants, aged 18 to less than 65 y.o. at time of
      consent, will be in the trial for up to 10 weeks.

      With empagliflozin:

        -  Control-IQ (CiQ) x 4 weeks (CiQ-EMPA) then Basal-IQ x 2 weeks (BiQ-EMPA)

        -  Basal-IQ x 2 weeks (BiQ-EMPA) then CiQ x 4 weeks (CiQ-EMPA)

      Without empagliflozin:

        -  CiQ x 4 weeks (CiQ-NO EMPA) then Basal-IQ x 2 weeks (BiQ-NO EMPA)

        -  Basal-IQ x 2 weeks (BiQ-NO EMPA) then CiQ x 4 weeks (CiQ-NO EMPA)
    

Intervention name(s): Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks; Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks; No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks; No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks
Intervention type(s): Combination Product; Combination Product; Device; Device
Intervention description(s): 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.; 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.; 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.; 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.
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be first randomized to taking empagliflozin or not taking this drug. Participants will then be randomized to using the Basal-IQ insulin pump first or the Control-IQ insulin pump first. Participants then transition to using the other pump.
With empagliflozin:
Control-IQ x 4 weeks (CiQ-EMPA) then Basal-IQ x 2 weeks (BiQ-EMPA)
Basal-IQ x 2 weeks (BiQ-EMPA) then Control-IQ x 4 weeks (CiQ-EMPA)
Without empagliflozin:
Control-IQ x 4 weeks (CiQ-NO EMPA) then Basal-IQ x 2 weeks (BiQ-NO EMPA)
Basal-IQ x 2 weeks (BiQ-NO EMPA) then Control-IQ x 4 weeks (CiQ-NO EMPA)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Pancreas (AP); Sodium-glucose co-transporter 2 (SGLT2) inhibitor; Insulin Pumps; Continuous Glucose Monitor (CGM); Closed Loop Control; Low blood glucose index (LBGI); High blood glucose index (HBGI)