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SGLT2 inhibitor
SGLT2 Inhibitor Monitoring for Type 1 Diabetes
Phase 4
Recruiting
Led By Janet B McGill, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Use of an insulin pump and ability to make adjustments to pump settings
Age 18 - 75, any gender, race or ethnicity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial will test whether a person's breath acetone can be used to identify ketosis in people with type 1 diabetes. This is important for the potential use of a certain type of diabetes medication.
Who is the study for?
Adults aged 18-75 with Type 1 Diabetes for over a year, HbA1c below 10%, using an insulin pump and Dexcom G6 CGM. Participants need good vision, ability to adjust their pump, and use specific apps on a smartphone. Exclusions include recent UTI or vomiting episodes, certain medication usage like corticosteroids or SGLT2i, unstable heart disease or cancer treatment within the past six months, history of severe ketosis-related conditions (DKA), low kidney function or hemoglobin levels.Check my eligibility
What is being tested?
The study is testing if breath acetone measurements can detect ketosis in Type 1 Diabetes patients when taking SGLT2 inhibitors. It involves using the Biosense Breath Ketone Analyzer alongside usual diabetes care to monitor safety and effectiveness of this drug class.See study design
What are the potential side effects?
Potential side effects may include dehydration due to increased urination caused by SGLT2 inhibitors and risk of diabetic ketoacidosis (a serious condition where high levels of acids build up in your blood).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I use an insulin pump and can adjust its settings.
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I am between 18 and 75 years old.
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I have had Type 1 diabetes for over a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ketone levels measured in blood and breath in persons with T1D in persons with T1D
Secondary outcome measures
Ketone levels in persons with T1D during usual care versus usual care plus SGLT2i treatment
Other outcome measures
Ketone levels in persons with T1D undergoing insulin withdrawal
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group B: Usual care plus dapagliflozin followed by usual careExperimental Treatment2 Interventions
10 persons with T1D will check capillary beta hydroxybutyrate (BOHB) and concomitant breath acetone (BrAce) 2 - 3 times daily for 2 weeks during usual care plus treatment with the SGLT2i dapagliflozin, 10 mg taken orally daily, then undergo an insulin withdrawal visit. Subsequently, the Group B patients will repeat the paired measurements of BOHB and BrAce, 2 - 3 times daily during usual care alone followed by an insulin withdrawal visit.
Group II: Group A: Usual care followed by usual care plus dapagliflozinExperimental Treatment2 Interventions
10 persons with T1D will check capillary beta hydroxybutyrate (BOHB) and concomitant breath acetone (BrAce) 2 - 3 times daily for 2 weeks during usual care, then undergo an insulin withdrawal visit. Subsequently, the Group A patients will repeat the paired measurements of BOHB and BrAce, 2 - 3 times daily for 2 weeks during usual care plus treatment with the SGLT2i dapagliflozin, 10 mg taken orally daily, followed by an insulin withdrawal visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SGLT2 inhibitor
2019
Completed Phase 3
~17850
Find a Location
Who is running the clinical trial?
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,764 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,675 Total Patients Enrolled
Janet B McGill, MDPrincipal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had diabetic ketoacidosis once in the last 6 months or more than once in the last 2 years.I have not been hospitalized for heart issues in the last 6 months.You can see well enough to read all the instructions and settings on a device, like an insulin pump.I am not taking disulfiram.I can attend all required visits and do tasks related to the study.I am a pre-menopausal woman using effective birth control.I have been on a consistent insulin regimen for the last 30 days.I use an insulin pump and can adjust its settings.My kidney function is low or I have low blood hemoglobin levels.I've been treated for cancer (excluding skin cancer) in the last 6 months or expect treatment soon.I take my insulin injections in the morning or am willing to switch to morning injections.I don't have any health issues that could affect the study or prevent me from taking SGLT2 inhibitors.I have had episodes of vomiting in the last 30 days or was hospitalized for cyclic vomiting in the past year.Your HbA1c level is less than 10%.I have used an SGLT2 inhibitor in the last 30 days or cannot tolerate it.I am between 18 and 75 years old.You have a mental health condition or substance abuse that affects your daily life or ability to manage diabetes.I use a specific type of long-acting insulin and can't switch to another type for 2 days before certain visits.You are currently on a low-carb or ketogenic diet, or you plan to start one.I have had a urinary tract infection in the last 3 months.I have had Type 1 diabetes for over a year.I have not used corticosteroids in the last 30 days and do not plan to during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: Usual care followed by usual care plus dapagliflozin
- Group 2: Group B: Usual care plus dapagliflozin followed by usual care
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research allow individuals aged 35 and over to participate?
"This clinical trial requires that all participants are in the 18 to 75 age range. It is noted, however, there exists 146 trials for minors and 169 studies exclusively catered towards elderly patients."
Answered by AI
Is this scientific research currently seeking participants?
"Clinicaltrials.gov states that this medical research is presently open for recruitment, with the initial posting occurring on October 14th 2022 and the latest update being made five days later."
Answered by AI
Has this remedy been approved by the Food and Drug Administration?
"Previous clinical research has indicated that this treatment is safe, thus it earned a rating of 3. This Phase 4 trial confirms the approval for use of this medication."
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How many participants are being enrolled in this research program?
"Correct. According to clinicaltrials.gov, the trial which was originally published on October 14th 2022 is actively recruiting participants from 1 facility and has a total target enrollment of 20 persons."
Answered by AI
What criteria is being used to select participants for this medical experiment?
"This clinical trial requires prospective participants to have diabetes, an autoimmune disorder, and be aged between 18-75. Approximately 20 people are being accepted into the study."
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