Ketone Monitoring for Type 1 Diabetes

(KARMA Trial)

JT
Overseen ByJaWanda Thacker
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: AdventHealth Translational Research Institute
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to see how well a special education plan using continuous ketone monitoring (DGK) works to lower the risk of a condition called diabetic ketoacidosis (DKA) in people with type 1 diabetes (T1D) taking SGLT2 inhibitors (a type of medication commonly used to treat type 2 diabetes). This special education plan is compared to a general education plan and considers the higher risk of DKA when using medicines like SGLT2 inhibitors.

Who Is on the Research Team?

RP

Richard Pratley, MD

Principal Investigator

AdventHealth

Are You a Good Fit for This Trial?

Inclusion Criteria

3. HbA1c \< 9 %
I use multiple daily insulin injections or an insulin pump.
5. Has provided written informed consent to participate in the study.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Monitoring

Participants receive a special education plan using continuous ketone monitoring to mitigate DKA risk

6 months

Follow-up

Participants are monitored for safety and effectiveness after the education and monitoring phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sotagliflozin

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: People with Type 1 DiabetesExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AdventHealth Translational Research Institute

Lead Sponsor

Trials
51
Recruited
5,900+