Diabetes Mellitus, Type 2
Conditions
Brief summary
This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED randomized control trial. The study is being conducted by the Minneapolis Heart Institute Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND). The study will examine the impact of a registered dietitian-led, primary care integrated, telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual care. The D5 goals include: blood pressure \<140/90 mmHg, taking a statin as appropriate, A1c \<8%, not using tobacco and taking an aspirin as appropriate.
Detailed description
Individuals will be invited to attend a baseline visit where they will have lab work done, anthropometrics (height, weight, waist circumference) and complete a lifestyle assessment. They will formally consent to participation by signing a study consent form. The same measures will be collected after completion of the one year study. Study participants will receive two sessions of free lab work, a diabetes education book, and brief coaching with a registered dietitian/certified diabetes educator. In addition, those randomized to the phone coaching will have access to a registered dietitian/certified diabetes educator on a monthly basis for one year of personalized health coaching for free. The intent of this coaching is to help individuals achieve diabetes optimal care or meeting all 5 Diabetes Care measures (blood glucose, blood pressure, tobacco use, statin and aspirin use). This program is designed to complement usual clinic-based primary care, with coaches documenting lab, biometrics and medication adjustments in the EHR, along with documenting phone encounters and communicating directly with patients' PCPs as needed. Documentation in the EHR uses an order created specifically for the study indicating the patient's research status. Lab work required as part of this research study at baseline and 12 months is covered by the study. Any lab work and/or medication co-pays or fees outside of the baseline and 12 month study visits are the responsibility of the patient and/or their insurance
Interventions
BEHAVIORALCoaching
Focus on nutrition, activity and appropriate medication use and adherence
Sponsors
Academy of Nutrition and Dietetics
Minneapolis Heart Institute Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Diagnosis of Type 2 Diabetes 2. Individuals who are not meeting 3 or more D5 goals, 3. Have had a visit with a provider within the last 2 years
Exclusion criteria
1. Type 1 Diabetes 2. Chronic kidney disease (GFR \<30) 3. HIV 4. Institutional residence 5. Major cognitive or language barrier (as determined by program enrollment staff) 6. Other active end-stage disease (e.g., late stage cancer or pulmonary disease) 7. Actively receiving cancer treatment 8. Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A1c (Laboratory Assessment) | 1 year | The count of participants represents the number of individuals meeting A1c less than 8% at follow up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings) | 1 year | The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up |
| Tobacco Use (Self-reported Questionnaire) | 1 year | The count of participants represents those not using tobacco at follow up |
| Statin Use (as Noted in EMR) | 1 year | The count of participants represents those taking a statin as indicated at follow up |
| Aspirin Use (as Noted in EMR) | 1 year | The count of participants represents taking aspirin as indicated at follow up |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 60 |
| Standard of Care Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need | 58 |
| Total | 118 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 20 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 98 Participants | 48 Participants |
| Age, Continuous | 60.0 Years STANDARD_DEVIATION 8.66 | 59.9 Years STANDARD_DEVIATION 9.43 | 59.8 Years STANDARD_DEVIATION 10.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 52 Participants | 108 Participants | 56 Participants |
| Region of Enrollment United States | 58 participants | 118 participants | 60 participants |
| Sex: Female, Male Female | 25 Participants | 53 Participants | 28 Participants |
| Sex: Female, Male Male | 33 Participants | 65 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 58 |
| other Total, other adverse events | 0 / 60 | 0 / 58 |
| serious Total, serious adverse events | 0 / 60 | 0 / 58 |
Outcome results
Primary
A1c (Laboratory Assessment)
The count of participants represents the number of individuals meeting A1c less than 8% at follow up
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | A1c (Laboratory Assessment) | 35 Participants |
| Standard of Care | A1c (Laboratory Assessment) | 35 Participants |
Other Pre-specified
Aspirin Use (as Noted in EMR)
The count of participants represents taking aspirin as indicated at follow up
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Aspirin Use (as Noted in EMR) | 45 Participants |
| Standard of Care | Aspirin Use (as Noted in EMR) | 34 Participants |
Other Pre-specified
Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)
The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings) | 24 Participants |
| Standard of Care | Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings) | 20 Participants |
Other Pre-specified
Statin Use (as Noted in EMR)
The count of participants represents those taking a statin as indicated at follow up
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Statin Use (as Noted in EMR) | 50 Participants |
| Standard of Care | Statin Use (as Noted in EMR) | 32 Participants |
Other Pre-specified
Tobacco Use (Self-reported Questionnaire)
The count of participants represents those not using tobacco at follow up
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Tobacco Use (Self-reported Questionnaire) | 44 Participants |
| Standard of Care | Tobacco Use (Self-reported Questionnaire) | 40 Participants |