Trial Outcomes & Findings for Mechanisms for Restoration of Hypoglycemia Awareness (NCT NCT03738852)
NCT ID: NCT03738852
Last Updated: 2025-02-12
Results Overview
Regional quantification of brain glucose levels with MRS (CMRgl) will be used to measure group differences.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
55 participants
Primary outcome timeframe
3 months
Results posted on
2025-02-12
Participant Flow
15 participants withdrew and 7 had IV issues
Participant milestones
| Measure |
Healthy Controls
Healthy controls Insulin: standard insulin regimen
|
Type 1 (T1) Diabetics
T1 aware, and T1 unawares
Insulin: standard insulin regimen
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
21
|
|
Overall Study
COMPLETED
|
12
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanisms for Restoration of Hypoglycemia Awareness
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=23 Participants
Healthy controls Insulin: standard insulin regimen
|
Type 1 (T1) Diabetics
n=32 Participants
T1 aware, and T1 unawares
Insulin: standard insulin regimen
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
32.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
32 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Systolic Blood Pressure
|
115.8 mmHg
STANDARD_DEVIATION 13.7 • n=5 Participants
|
120.5 mmHg
STANDARD_DEVIATION 12.5 • n=7 Participants
|
117.1 mmHg
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Diastolic Blood Pressure
|
73.3 mmHg
STANDARD_DEVIATION 11.7 • n=5 Participants
|
75.5 mmHg
STANDARD_DEVIATION 8.8 • n=7 Participants
|
74.5 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsRegional quantification of brain glucose levels with MRS (CMRgl) will be used to measure group differences.
Outcome measures
| Measure |
Healthy Controls
n=12 Participants
Healthy controls Insulin: standard insulin regimen
|
Type 1 (T1) Diabetics
n=21 Participants
T1 aware, and T1 unawares
Insulin: standard insulin regimen
|
|---|---|---|
|
Brain Glucose Levels
|
2.45 Mmol/L
Standard Deviation 0.6
|
2.16 Mmol/L
Standard Deviation 05
|
Adverse Events
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Type 1 (T1) Diabetics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Renata Belfort De Aguiar, MD, PhD
Yale School of Medicine
Phone: (203) 785-5331
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place