Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes (T2D)
Conditions
Brief summary
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.
Interventions
BEHAVIORALAugmented Initial Type 2 Diabetes Care
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.
Sponsors
Kaiser Permanente
The Permanente Medical Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-74 years * Newly diagnosed with type 2 diabetes * Kaiser Permanente Northern California member receiving care in a participating service area * If age ≤45 years, then HbA1c\>8% * If age\<45 years, then HbA1c\>10%
Exclusion criteria
* Individuals who are pregnant * Individuals with likely type 1 diabetes (T1D)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average hemoglobin A1c (HbA1c) | 6-months | Between-arm differences in HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to achievement of glycemic targets | 6-months | — |
| Adherence to HbA1c monitoring | 6-months | Number of participants with a new HbA1c laboratory value |
| Type 2 diabetes medication and statin initiation | 6-months | Number of participants who are prescribed a type 2 diabetes medication and/or statin |
| Type 2 diabetes medication adherence | 6-months | Proportion of days covered since initiation |
| Completion of preventative screening | 6-months | Number of participants who complete retinal and microalbuminuria screening |
Countries
United States
Outcome results
None listed