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| Name | Class |
|---|---|
| The Permanente Medical Group | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Initial Type 2 Diabetes (T2D) Care | No Intervention | Patients in the usual care arm will receive the standard T2D care provided to Kaiser Permanente Northern California members with recently diagnosed T2D. This care includes any counseling or treatment recommendations made by the primary care provider and the assigned care manager. | |
| Augmented Initial Type 2 Diabetes (T2D) Care | Experimental | The intervention - Augmented Initial T2D Care - comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team and self-management support by care managers, health educators, and dieticians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented Initial Type 2 Diabetes Care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average hemoglobin A1c (HbA1c) | Between-arm differences in HbA1c | 6-months |
| Average hemoglobin A1c (HbA1c) | Between-arm differences in HbA1c | 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achievement of glycemic targets | 6-months | |
| Time to achievement of glycemic targets | 12-months | |
| Adherence to HbA1c monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Division of Research | Pleasanton | California | 94588 | United States |
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|
Number of participants with a new HbA1c laboratory value |
| 6-months |
| Adherence to HbA1c monitoring | Number of participants with a new HbA1c laboratory value | 12-months |
| Type 2 diabetes medication and statin initiation | Number of participants who are prescribed a type 2 diabetes medication and/or statin | 6-months |
| Type 2 diabetes medication and statin initiation | Number of participants who are prescribed a type 2 diabetes medication and/or statin | 12-months |
| Type 2 diabetes medication adherence | Proportion of days covered since initiation | 6-months |
| Type 2 diabetes medication adherence | Proportion of days covered since initiation | 12-months |
| Completion of preventative screening | Number of participants who complete retinal and microalbuminuria screening | 6-months |
| Completion of preventative screening | Number of participants who complete retinal and microalbuminuria screening | 12-months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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