Trial Outcomes & Findings for A Patient-Centered PaTH to Addressing Diabetes (NCT NCT02788903)
NCT ID: NCT02788903
Last Updated: 2024-07-03
Results Overview
Number of patients who utilized IBT services was assessed in both the diabetes and pre-diabetes cohorts using code G0447.
Recruitment status
COMPLETED
Target enrollment
2622164 participants
Primary outcome timeframe
11 years
Results posted on
2024-07-03
Participant Flow
Participants' data was analyzed as part of a secondary data analysis analyzing de-identified EHR and Claims data. Participants did not consent to participate in this study.
Participants were not randomized for this study.
Participant milestones
| Measure |
Diabetes
During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes
|
Pre-Diabetes
The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
|
|---|---|---|
|
Overall Study
STARTED
|
567908
|
2054256
|
|
Overall Study
COMPLETED
|
567908
|
2054256
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Patient-Centered PaTH to Addressing Diabetes
Baseline characteristics by cohort
| Measure |
Diabetes
n=567 Participants
During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes
|
Pre-Diabetes
n=2 Participants
The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
|
Total
n=2622164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 18-24 years
|
10,371 Participants
n=93 Participants
|
259,691 Participants
n=4 Participants
|
270062 Participants
n=27 Participants
|
|
Age, Customized
Age · 25-34 years
|
23,169 Participants
n=93 Participants
|
355,885 Participants
n=4 Participants
|
379054 Participants
n=27 Participants
|
|
Age, Customized
Age · 35-44 years
|
51,885 Participants
n=93 Participants
|
340,065 Participants
n=4 Participants
|
391950 Participants
n=27 Participants
|
|
Age, Customized
Age · 45-54 years
|
105,646 Participants
n=93 Participants
|
374,446 Participants
n=4 Participants
|
480092 Participants
n=27 Participants
|
|
Age, Customized
Age · 55-64 years
|
151,061 Participants
n=93 Participants
|
346,075 Participants
n=4 Participants
|
497136 Participants
n=27 Participants
|
|
Age, Customized
Age · 65-74 years
|
131,104 Participants
n=93 Participants
|
224,386 Participants
n=4 Participants
|
355490 Participants
n=27 Participants
|
|
Age, Customized
Age · >75 years
|
94,672 Participants
n=93 Participants
|
153,708 Participants
n=4 Participants
|
248380 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
287,725 Participants
n=93 Participants
|
1,167,327 Participants
n=4 Participants
|
1455052 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
280,170 Participants
n=93 Participants
|
886,884 Participants
n=4 Participants
|
1167054 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Sex · Other/Missing
|
13 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29,211 Participants
n=93 Participants
|
105,438 Participants
n=4 Participants
|
134649 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
514,125 Participants
n=93 Participants
|
1,855,612 Participants
n=4 Participants
|
2369737 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
24,572 Participants
n=93 Participants
|
93,206 Participants
n=4 Participants
|
117778 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1,860 Participants
n=93 Participants
|
4,725 Participants
n=4 Participants
|
6585 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
10,809 Participants
n=93 Participants
|
35,410 Participants
n=4 Participants
|
46219 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
79,732 Participants
n=93 Participants
|
216,860 Participants
n=4 Participants
|
296592 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiin or Other Pacific Islander
|
1,311 Participants
n=93 Participants
|
4,413 Participants
n=4 Participants
|
5724 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
438,948 Participants
n=93 Participants
|
1,667,767 Participants
n=4 Participants
|
2106715 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple Race
|
397 Participants
n=93 Participants
|
1,879 Participants
n=4 Participants
|
2276 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Other/Missing
|
34,851 Participants
n=93 Participants
|
123,202 Participants
n=4 Participants
|
158053 Participants
n=27 Participants
|
|
Region of Enrollment
United States · Rural
|
31,402 Participants
n=93 Participants
|
92,934 Participants
n=4 Participants
|
124336 Participants
n=27 Participants
|
|
Region of Enrollment
United States · Urban
|
470,209 Participants
n=93 Participants
|
1,744,529 Participants
n=4 Participants
|
2214738 Participants
n=27 Participants
|
|
Region of Enrollment
United States · Missing
|
66,297 Participants
n=93 Participants
|
216,793 Participants
n=4 Participants
|
283090 Participants
n=27 Participants
|
|
BMI
|
32.9 kg/m^2
STANDARD_DEVIATION 7.9 • n=93 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 6.2 • n=4 Participants
|
31.55 kg/m^2
STANDARD_DEVIATION 7.14 • n=27 Participants
|
|
Diastolic Blood Pressure
|
75.0 mm Hg
STANDARD_DEVIATION 7.7 • n=93 Participants
|
76.6 mm Hg
STANDARD_DEVIATION 7.4 • n=4 Participants
|
75.24 mm Hg
STANDARD_DEVIATION 10.67 • n=27 Participants
|
|
Systolic Blood Pressure
|
130.4 mm Hg
STANDARD_DEVIATION 12.1 • n=93 Participants
|
126.0 mm Hg
STANDARD_DEVIATION 11.9 • n=4 Participants
|
127.03 mm Hg
STANDARD_DEVIATION 17.07 • n=27 Participants
|
|
Hemoglobin A1c
|
7.0 mg/dL
n=93 Participants
|
5.6 mg/dL
n=4 Participants
|
6.9 mg/dL
n=27 Participants
|
PRIMARY outcome
Timeframe: 11 yearsNumber of patients who utilized IBT services was assessed in both the diabetes and pre-diabetes cohorts using code G0447.
Outcome measures
| Measure |
Diabetes
n=567 Participants
During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes
|
Pre-Diabetes
n=2 Participants
The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
|
|---|---|---|
|
Number of Participants Who Used the Intensive Behavioral Therapy (IBT) Service
|
2417 Participants
|
3731 Participants
|
PRIMARY outcome
Timeframe: 11 yearsWeight change during counseling and/or % of weight change during program and maintained over remaining time period will be assessed in both the diabetes and pre-diabetes cohorts.
Outcome measures
| Measure |
Diabetes
n=567 Participants
During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes
|
Pre-Diabetes
n=2 Participants
The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
|
|---|---|---|
|
Change in Weight During Counseling Program
|
206.8 lbs
Standard Deviation 55.0
|
194.8 lbs
Standard Deviation 44.9
|
PRIMARY outcome
Timeframe: 1 yearA1c of patients who received a telehealth visit and COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.
Outcome measures
| Measure |
Diabetes
n=567 Participants
During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes
|
Pre-Diabetes
n=2 Participants
The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
|
|---|---|---|
|
Hemoglobin A1c
|
6.6 mmol/mol
Standard Deviation 1.5
|
6.6 mmol/mol
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: 1 yearNumber of Participants Diagnosed with COVID-19 Who Were Hospitalized in both the diabetes and pre-diabetes cohorts.
Outcome measures
| Measure |
Diabetes
n=567 Participants
During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes
|
Pre-Diabetes
n=2 Participants
The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
|
|---|---|---|
|
Number of Participants Diagnosed With COVID-19 Who Were Hospitalized
|
1,025 Participants
|
1,379 Participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of patients who received telehealth and were hospitalized with a COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.
Outcome measures
| Measure |
Diabetes
n=567 Participants
During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes
|
Pre-Diabetes
n=2 Participants
The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
|
|---|---|---|
|
Number of Patients Who Received Telehealth and Were Hospitalized With a COVID-19 Diagnosis
|
639 Participants
|
838 Participants
|
SECONDARY outcome
Timeframe: 11 yearsThe number of patients with uncontrolled blood pressure (SBP \> 140, DBP \> 90 all the time, defined for 1-year prior to first IBTb visit, and 1-year after) in the diabetes and pre-diabetes cohorts
Outcome measures
| Measure |
Diabetes
n=567 Participants
During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes
|
Pre-Diabetes
n=2 Participants
The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
|
|---|---|---|
|
Number of Patients With Uncontrolled Blood Pressure
|
300,665 Participants
|
928,366 Participants
|
SECONDARY outcome
Timeframe: 11 yearsThe number of patients with uncontrolled hemoglobin A1c (HbA1cc \> 9 any time, defined for 1-year prior to first IBTb visit, and 1-year after) in the diabetes and pre-diabetes cohorts.
Outcome measures
| Measure |
Diabetes
n=567 Participants
During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes
|
Pre-Diabetes
n=2 Participants
The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
|
|---|---|---|
|
Number of Patients With Uncontrolled Hemoglobin A1c
|
79,046 Participants
|
164 Participants
|
SECONDARY outcome
Timeframe: 1 yearIncidence of ICU admission, ventilator use, or death in patients with a COVID-19 diagnosis in both the diabetes and pre-diabetes cohorts.
Outcome measures
| Measure |
Diabetes
n=567 Participants
During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019).
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes
|
Pre-Diabetes
n=2 Participants
The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height.
Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
|
|---|---|---|
|
Number of Patients With a COVID-19 Diagnosis and ICU Use, Ventilator Use, or Death
|
586 Participants
|
500 Participants
|
Adverse Events
Diabetes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-Diabetes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COVID-19
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place