Ketone Monitoring in T1D: Effect of SGLT2i During Usual Care and With Insulin Deficiency

• Status: Not yet recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This proposed study will test whether measurement of breath acetone (BrAce) can be used for the purpose of identifying ketosis (elevated ketones) in persons with type 1 diabetes (T1D). This is important for the potential use of sodium glucose co-transport inhibitors (SGLT2i) in persons with T1D.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Juvenile Diabetes Research Foundation
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• Type 1 diabetes for >1 year

• Age 18 - 75, any gender, race or ethnicity

• HbA1c <10%

• Stable insulin delivery method for the past 30 days

• Vision of 20/40 or better, including ability to read all device instructions and insulin pump settings

• Use of an insulin pump and ability to make adjustments to pump settings

• Insulin delivery by MDI with basal insulin (glargine U100) given in the morning

• Use of personal CGM, only Dexcom G6 will be permitted for data consistency

• Use of cellular phone (iOS7 and above or Android) with data capability with connectivity to Dexcom Clarity app and Biosense Ketone Monitoring app

• Willing to share CGM, capillary ketone results and BrACE data with the study group

• Able to understand the study requirements, risks and benefits and able to provide written informed consent

• Able to schedule the visits and perform study related tasks

Exclusion Criteria:

• History of DKA in the past 6 months, or more than 1 episode of DKA in the past 2 years

• Use of insulin degludec, insulin glargine U300 or insulin detemir as basal insulin

• Use of an SGLT2i in the past 30 days or intolerance to SGLT2i use in the past for any reason

• Unstable heart disease, including hospitalization for any cardiac or vascular event in the past 6 months.

• eGFR <30 ml/min/1.73m2 or hemoglobin <11.0 g/dL measured in the past year

• Cancer that has been under treatment in the past 6 months, or treatment is likely in the 3 months after signing the consent, not including skin cancer or cancers under long-term hormonal reduction treatment (breast or prostate, no other active treatment)

• Psychiatric condition that interferes with daily activities or diabetes self-care, including substance abuse

• Any illness or condition that may interfere with study measurements, or contraindications for use of SGLT2i, based on investigator discretion (hemoglobinopathy, orthostatic hypotension)

• Unwilling to avoid alcohol during the active study periods, specifically to avoid alcohol for 4 hours prior to any breath ketone measurement

• Currently following or planning to adopt a diet that is low in carbohydrates (defined as <90 grams of carbohydrate per day) or is expected to be ketogenic

• Use of oral or injected corticosteroids within the past 30 days or planned during the study period

• Taking disulfiram (due to interference with breath ketone measurements)

• History of vomiting episodes for any reason in the past 30 days, or hospitalization for cyclic vomiting in the past year

• History of urinary tract infection in the past 3 months

• Pregnancy, breast-feeding or intention of becoming pregnant during the study time period and up to 30 days after study completion

• Pre-menopausal women not using acceptable birth control defined as abstinence, surgical sterilization, hysterectomy, hormonal contraception, IUD or proven effective barrier methods