Trial Outcomes & Findings for Ketone Monitoring in T1D: Effect of SGLT2i During Usual Care and With Insulin Deficiency (NCT NCT05541484)
NCT ID: NCT05541484
Last Updated: 2025-02-21
Results Overview
Differences between usual care v dapagliflozin of capillary beta hydroxybutyrate (BOHB) measurements during outpatient care.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Measurements were taken 2-3 times daily for 2 weeks
Results posted on
2025-02-21
Participant Flow
Participant milestones
| Measure |
Group A: Usual Care Followed by Usual Care Plus Dapagliflozin
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.
SGLT2 inhibitor: See above.
Biosense Breath Ketone Analyzer: The hand-held device tests ketones in exhaled breath
|
Group B: Usual Care Plus Dapagliflozin Followed by Usual Care
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.
SGLT2 inhibitor: See above.
Biosense Breath Ketone Analyzer: The hand-held device tests ketones in exhaled breath
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group A: Usual Care Followed by Usual Care Plus Dapagliflozin
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.
SGLT2 inhibitor: See above.
Biosense Breath Ketone Analyzer: The hand-held device tests ketones in exhaled breath
|
Group B: Usual Care Plus Dapagliflozin Followed by Usual Care
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.
SGLT2 inhibitor: See above.
Biosense Breath Ketone Analyzer: The hand-held device tests ketones in exhaled breath
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Ketone Monitoring in T1D: Effect of SGLT2i During Usual Care and With Insulin Deficiency
Baseline characteristics by cohort
| Measure |
Usual Care (UC) or Dapagliflozin (DAPA)
n=20 Participants
20 persons with T1D
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 18.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Measurements were taken 2-3 times daily for 2 weeksDifferences between usual care v dapagliflozin of capillary beta hydroxybutyrate (BOHB) measurements during outpatient care.
Outcome measures
| Measure |
Usual Care
n=718 measurements
Two weeks of outpatient care measurements
|
Dapagliflozin
n=707 measurements
Two weeks of outpatient care measurements while taking dapagliflozin
|
|---|---|---|
|
Capillary Blood Beta-hydroxybutyrate (BOHB) During Outpatient Care
|
0.1 mmol/L
Interval 0.1 to 0.2
|
0.2 mmol/L
Interval 0.1 to 0.3
|
PRIMARY outcome
Timeframe: Measurements were taken 2-3 times daily for 2 weeksDifferences of breath acetone (BrACE) measurements between usual care v dapagliflozin during outpatient care.
Outcome measures
| Measure |
Usual Care
n=20 Participants
Two weeks of outpatient care measurements
|
Dapagliflozin
n=20 Participants
Two weeks of outpatient care measurements while taking dapagliflozin
|
|---|---|---|
|
Breath Acetone (BrACE) During Outpatient Care
|
1 AU (ppm)
Interval 1.0 to 3.0
|
2 AU (ppm)
Interval 1.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 daysComparison of ketone levels (BOHB and BrAce) during insulin withdrawal after usual care and during insulin withdrawal after usual care plus treatment with an SGLT2i.
Outcome measures
Outcome data not reported
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Care Plus Dapagliflozin (Dapagliflozin)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Usual Care
n=20 participants at risk
20 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.
Biosense Breath Ketone Analyzer: The hand-held device tests ketones in exhaled breath
|
Usual Care Plus Dapagliflozin (Dapagliflozin)
n=20 participants at risk
20 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.
Biosense Breath Ketone Analyzer: The hand-held device tests ketones in exhaled breath
|
|---|---|---|
|
Endocrine disorders
nausea
|
0.00%
0/20 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
20.0%
4/20 • Number of events 4 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
|
Endocrine disorders
hypoglycemia
|
0.00%
0/20 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
20.0%
4/20 • Number of events 4 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
|
Cardiac disorders
palpitations
|
0.00%
0/20 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
5.0%
1/20 • Number of events 1 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
|
Gastrointestinal disorders
gastroenteritis
|
0.00%
0/20 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
5.0%
1/20 • Number of events 1 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
|
Endocrine disorders
hyperglycemia
|
5.0%
1/20 • Number of events 1 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
0.00%
0/20 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
|
Endocrine disorders
fatigue
|
0.00%
0/20 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
5.0%
1/20 • Number of events 1 • two weeks of outpatient care
Adverse event and/or serious adverse event uses the same definition as clinicaltrials.gov
|
Additional Information
Janet McGill, Professor Medicine
Washington University School of Medicine
Phone: 314-273-3929
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place