Type 2 DiabetesNCT06906653
Population Health Management for KPNC Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy
A study testing Augmented Initial Type 2 Diabetes Care in people with Type 2 Diabetes and Type 2 Diabetes Mellitus (T2DM), run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes (T2D)
- What is being tested?
- Augmented Initial Type 2 Diabetes Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Individuals who are pregnant
- Individuals with likely type 1 diabetes (T1D)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kaiser Permanente Division of Research
Pleasanton, California, 94588
About this study
Official 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
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.
- Being tested
- Augmented Initial Type 2 Diabetes Care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Initial Type 2 Diabetes CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Augmented Initial Type 2 Diabetes Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average hemoglobin A1c (HbA1c)
Between-arm differences in HbA1c
Measured: 6-months
Average hemoglobin A1c (HbA1c)
Between-arm differences in HbA1c
Measured: 12-months
Secondary outcomes (10)
Time to achievement of glycemic targets
Measured: 6-months
Time to achievement of glycemic targets
Measured: 12-months
Adherence to HbA1c monitoring
Number of participants with a new HbA1c laboratory value
Measured: 6-months
Adherence to HbA1c monitoring
Number of participants with a new HbA1c laboratory value
Measured: 12-months
Type 2 diabetes medication and statin initiation
Number of participants who are prescribed a type 2 diabetes medication and/or statin
Measured: 6-months
Type 2 diabetes medication and statin initiation
Number of participants who are prescribed a type 2 diabetes medication and/or statin
Measured: 12-months
Type 2 diabetes medication adherence
Proportion of days covered since initiation
Measured: 6-months
Type 2 diabetes medication adherence
Proportion of days covered since initiation
Measured: 12-months
Completion of preventative screening
Number of participants who complete retinal and microalbuminuria screening
Measured: 6-months
Completion of preventative screening
Number of participants who complete retinal and microalbuminuria screening
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- The Permanente Medical Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906653
- Sponsor's protocol ID
- 2220224
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06906653
- Acronym / sponsor ID
- 2220224
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- The Permanente Medical Group
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Augmented Initial Type 2 Diabetes CareThe 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (2 listed)
- Individuals who are pregnant
- Individuals with likely type 1 diabetes (T1D)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Initial Type 2 Diabetes CareThe 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. | Behavioural | Augmented Initial Type 2 Diabetes (T2D) Care |
Primary outcome
Average hemoglobin A1c (HbA1c)
Time frame: 6-months
Between-arm differences in HbA1c
Average hemoglobin A1c (HbA1c)
Time frame: 12-months
Between-arm differences in HbA1c
10 secondary outcomes
Time to achievement of glycemic targets
Time frame: 6-months
Time to achievement of glycemic targets
Time frame: 12-months
Adherence to HbA1c monitoring
Time frame: 6-months
Adherence to HbA1c monitoring
Time frame: 12-months
Type 2 diabetes medication and statin initiation
Time frame: 6-months
Type 2 diabetes medication and statin initiation
Time frame: 12-months
Type 2 diabetes medication adherence
Time frame: 6-months
Type 2 diabetes medication adherence
Time frame: 12-months
Completion of preventative screening
Time frame: 6-months
Completion of preventative screening
Time frame: 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Initial Type 2 Diabetes Care in people with Type 2 Diabetes and Type 2 Diabetes Mellitus (T2DM), run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average hemoglobin A1c (HbA1c) (time frame: 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.