SGLT2 Inhibitor Adjunctive Therapy to Closed Loop Control in Type 1 Diabetes Mellitus
CiQ-SGLT2
2 other identifiers
interventional
34
1 country
1
Brief Summary
The primary purpose of this study is to evaluate the safety and efficacy of combining SGLT2 inhibitors with closed loop control (CLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
December 17, 2019
CompletedStudy Start
First participant enrolled
February 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2021
CompletedAugust 11, 2022
August 1, 2022
1.5 years
November 4, 2019
August 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 weeks
Secondary Outcomes (14)
Time below 70 mg/dl
6 weeks
Time above 180 mg/dl
6 weeks
Time between 70-140 mg/dl 5 hours post prandial
6 weeks
Glucose variability index HBGI
6 weeks
Glucose variability index LBGI
6 weeks
- +9 more secondary outcomes
Study Arms (4)
Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks
EXPERIMENTALControl-IQ x 4 weeks (CiQ-EMPA) then Basal-IQ x 2 weeks (BiQ-EMPA)
Empagliflozin + Basal-IQ x 2 wks then CiQ x 4 wks
EXPERIMENTALBasal-IQ x 2 weeks (BiQ-EMPA) then Control-IQ x 4 weeks (CiQ-EMPA)
No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks
ACTIVE COMPARATORControl-IQ x 4 weeks (CiQ-NO EMPA) then Basal-IQ x 2 weeks (BiQ-NO EMPA)
No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks
ACTIVE COMPARATORBasal-IQ x 2 weeks (BiQ-NO EMPA) then Control-IQ x 4 weeks (CiQ-NO EMPA)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥18.0 and ≤65 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
- Currently using an insulin pump for at least six months
- Currently using insulin for at least six months
- Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
- Access to internet and willingness to upload data during the study as needed
- For females, not currently known to be pregnant or breastfeeding
- If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- Total daily insulin dose (TDD) at least 10 U/day
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- Willingness to eat at least 100 grams of carbohydrates per day
- An understanding and willingness to follow the protocol and signed informed consent
- Pilot Participants: Agree to hotel/research house admission with other Pilot participants on a date selected by the study team.
You may not qualify if:
- Hemoglobin A1c \>9%
- History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently breastfeeding or planning to breastfeed
- Currently being treated for a seizure disorder
- Planned surgery during study duration
- History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
- Clinically significant electrocardiogram (ECG) abnormality at time of Screening, as interpreted by the study medical physician
- Use of diuretics (e.g. Lasix, Thiazides)
- History of chronic or recurrent genital infections
- eGFR lab value below 60 mL/min/1.73 m2
- Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- Severe renal impairment, end-stage renal disease, or dialysis
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ananda Basu, MDlead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- Tandem Diabetes Care, Inc.collaborator
- DexCom, Inc.collaborator
Study Sites (1)
University of Virginia, Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
Related Publications (1)
Garcia-Tirado J, Farhy L, Nass R, Kollar L, Clancy-Oliveri M, Basu R, Kovatchev B, Basu A. Automated Insulin Delivery with SGLT2i Combination Therapy in Type 1 Diabetes. Diabetes Technol Ther. 2022 Jul;24(7):461-470. doi: 10.1089/dia.2021.0542. Epub 2022 Mar 14.
PMID: 35255229DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ananda Basu, MD
University of Virginia
- STUDY CHAIR
Ralf Nass, MD
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 4, 2019
First Posted
December 17, 2019
Study Start
February 24, 2020
Primary Completion
September 7, 2021
Study Completion
September 7, 2021
Last Updated
August 11, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After publication for one year
To be determined