Trial Outcomes & Findings for diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED) (NCT NCT02980978)
NCT ID: NCT02980978
Last Updated: 2019-07-29
Results Overview
The count of participants represents the number of individuals meeting A1c less than 8% at follow up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
1 year
Results posted on
2019-07-29
Participant Flow
Participant milestones
| Measure |
Intervention
Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals
Coaching: Focus on nutrition, activity and appropriate medication use and adherence
|
Standard of Care
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
58
|
|
Overall Study
COMPLETED
|
54
|
50
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)
Baseline characteristics by cohort
| Measure |
Intervention
n=60 Participants
Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals
Coaching: Focus on nutrition, activity and appropriate medication use and adherence
|
Standard of Care
n=58 Participants
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
59.8 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
60.0 Years
STANDARD_DEVIATION 8.66 • n=7 Participants
|
59.9 Years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
58 participants
n=7 Participants
|
118 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe count of participants represents the number of individuals meeting A1c less than 8% at follow up
Outcome measures
| Measure |
Intervention
n=54 Participants
Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals
Coaching: Focus on nutrition, activity and appropriate medication use and adherence
|
Standard of Care
n=50 Participants
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
|
|---|---|---|
|
A1c (Laboratory Assessment)
|
35 Participants
|
35 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearThe count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up
Outcome measures
| Measure |
Intervention
n=54 Participants
Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals
Coaching: Focus on nutrition, activity and appropriate medication use and adherence
|
Standard of Care
n=50 Participants
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
|
|---|---|---|
|
Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)
|
24 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearThe count of participants represents those not using tobacco at follow up
Outcome measures
| Measure |
Intervention
n=54 Participants
Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals
Coaching: Focus on nutrition, activity and appropriate medication use and adherence
|
Standard of Care
n=50 Participants
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
|
|---|---|---|
|
Tobacco Use (Self-reported Questionnaire)
|
44 Participants
|
40 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearThe count of participants represents those taking a statin as indicated at follow up
Outcome measures
| Measure |
Intervention
n=54 Participants
Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals
Coaching: Focus on nutrition, activity and appropriate medication use and adherence
|
Standard of Care
n=50 Participants
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
|
|---|---|---|
|
Statin Use (as Noted in EMR)
|
50 Participants
|
32 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearThe count of participants represents taking aspirin as indicated at follow up
Outcome measures
| Measure |
Intervention
n=54 Participants
Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals
Coaching: Focus on nutrition, activity and appropriate medication use and adherence
|
Standard of Care
n=50 Participants
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
|
|---|---|---|
|
Aspirin Use (as Noted in EMR)
|
45 Participants
|
34 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
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
Population Health Program Manager
Minneapolis Heart Institute Foundation
Phone: 612-863-4222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place