This study is a 2-arm randomized trial of Augmented Initial Type 2 Diabetes (T2D) Care vs. Usual Initial T2D Care among adults (18-74 years) with newly diagnosed T2D who have risk factors (defined by age and diagnosis HbA1c value) for suboptimal early glycemic control. Augmented Initial T2D Care comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team. The study team will use electronic health record (EHR) data to assess between-arm differences in diabetes-related outcomes at 6- and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
204
The intervention will include 4 components: 1) Making primary care providers (PCPs) aware that the patient has been selected to receive "Augmented Initial Type 2 Diabetes (T2D) Care", 2) encouraging early care manager outreach to establish care, ensure prescribing of appropriate medications, and support medication adherence, 3) a one-on-one virtual health educator visit to reinforce self-management education and ensure set-up of remote glucose monitoring or continuous glucose monitoring (if eligible), and 4) a one-on-one virtual nutrition visit to provide individualized counseling.
Kaiser Permanente Division of Research
Pleasanton, California, United States
Average hemoglobin A1c (HbA1c)
Between-arm differences in HbA1c
Time frame: 6-months
Average hemoglobin A1c (HbA1c)
Between-arm differences in HbA1c
Time frame: 12-months
Time to achievement of glycemic targets
Time frame: 6-months
Time to achievement of glycemic targets
Time frame: 12-months
Adherence to HbA1c monitoring
Number of participants with a new HbA1c laboratory value
Time frame: 6-months
Adherence to HbA1c monitoring
Number of participants with a new HbA1c laboratory value
Time frame: 12-months
Type 2 diabetes medication and statin initiation
Number of participants who are prescribed a type 2 diabetes medication and/or statin
Time frame: 6-months
Type 2 diabetes medication and statin initiation
Number of participants who are prescribed a type 2 diabetes medication and/or statin
Time frame: 12-months
Type 2 diabetes medication adherence
Proportion of days covered since initiation
Time frame: 6-months
Type 2 diabetes medication adherence
Proportion of days covered since initiation
Time frame: 12-months
Completion of preventative screening
Number of participants who complete retinal and microalbuminuria screening
Time frame: 6-months
Completion of preventative screening
Number of participants who complete retinal and microalbuminuria screening
Time frame: 12-months
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