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Enrolling by Invitation

NCT Number: NCT06906653

Population Health Management for KPNC Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes (T2D) Type 2 Diabetes Mellitus (T2DM)

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Division of Research

Pleasanton, California, 94588, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Average hemoglobin A1c (HbA1c)

    Time frame: 6-months

    Between-arm differences in HbA1c

  2. Average hemoglobin A1c (HbA1c)

    Time frame: 12-months

    Between-arm differences in HbA1c

Secondary outcomes

  1. Time to achievement of glycemic targets

    Time frame: 6-months

  2. Time to achievement of glycemic targets

    Time frame: 12-months

  3. Adherence to HbA1c monitoring

    Time frame: 6-months

    Number of participants with a new HbA1c laboratory value

  4. Adherence to HbA1c monitoring

    Time frame: 12-months

    Number of participants with a new HbA1c laboratory value

  5. Type 2 diabetes medication and statin initiation

    Time frame: 6-months

    Number of participants who are prescribed a type 2 diabetes medication and/or statin

  6. Type 2 diabetes medication and statin initiation

    Time frame: 12-months

    Number of participants who are prescribed a type 2 diabetes medication and/or statin

  7. Type 2 diabetes medication adherence

    Time frame: 6-months

    Proportion of days covered since initiation

  8. Type 2 diabetes medication adherence

    Time frame: 12-months

    Proportion of days covered since initiation

  9. Completion of preventative screening

    Time frame: 6-months

    Number of participants who complete retinal and microalbuminuria screening

  10. Completion of preventative screening

    Time frame: 12-months

    Number of participants who complete retinal and microalbuminuria screening

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • The Permanente Medical Group

Registry information

Official study title

Population Health Management for Kaiser Permanente Northern California (KPNC) Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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