The primary purpose of this study is to evaluate the safety and efficacy of combining SGLT2 inhibitors with closed loop control (CLC).
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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.
University of Virginia, Center for Diabetes Technology
Charlottesville, Virginia, United States
CGM-measured time in the target range 70-180mg/dl (TIR) during the day
CGM-measured time in the target range 70-180mg/dl (TIR) during the day
Time frame: 6 weeks
Time below 70 mg/dl
Time below 70 mg/dl
Time frame: 6 weeks
Time above 180 mg/dl
Time above 180 mg/dl
Time frame: 6 weeks
Time between 70-140 mg/dl 5 hours post prandial
Time between 70-140 mg/dl 5 hours post prandial
Time frame: 6 weeks
Glucose variability index HBGI
Glucose variability index HBGI
Time frame: 6 weeks
Glucose variability index LBGI
Glucose variability index LBGI
Time frame: 6 weeks
Glucose variability index ADRR
Glucose variability index ADRR
Time frame: 6 weeks
Safety evaluation of empagliflozin as adjuvant therapy added to a closed loop artificial pancreas system
Number of episodes of diabetic ketoacidosis (DKA)
Time frame: 6 weeks
Safety evaluation of empagliflozin as adjuvant therapy added to a closed loop artificial pancreas system
Number of episodes of severe hypoglycemia (glucose \<50 mg/dl)
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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.
Time frame: 6 weeks
Episodes of diabetes ketoacidosis (DKA)
The number of DKA events in the experimental group as compared to the control group
Time frame: 6 weeks
Episodes of severe hypoglycemia (glucose <50 mg/dL)
The number of hypoglycemic events in the experimental group as compared to the control group
Time frame: 6 weeks
Genital infections
Number of genital infections (balanitis, urethritis, vulvar infections, Fournier's gangrene) that occur in the experimental group versus the control group
Time frame: 6 weeks
Urinary Tract Infections
Number of urinary tract infections that occur in the experimental group versus the control group
Time frame: 6 weeks
Total amount of insulin used
The number of amount of insulin used in the experimental group as compared to the control group
Time frame: 6 weeks
Number of hyperglycemic episodes as defined by contiguous CGM above 300 mg/dL
Number of hyperglycemic episodes, defined as contiguous CGM values above 300 mg/dL, that occur in the experimental group versus the control group
Time frame: 6 weeks