Augmented Initial Care for Type 2 Diabetes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Pregnancy, Type 1 diabetes

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a more proactive and intensive approach to initial diabetes care leads to better outcomes for people newly diagnosed with type 2 diabetes. Participants will receive either standard care or enhanced support, which includes more frequent contact with a diabetes care team and additional self-management help from health educators and dieticians. This enhanced support is called "Augmented Initial Type 2 Diabetes Care." The goal is to compare how these two groups manage their blood sugar levels over 6 and 12 months. This trial suits Kaiser Permanente Northern California members recently diagnosed with type 2 diabetes who have specific risk factors for poor blood sugar control. As an unphased trial, it offers participants the chance to contribute to innovative diabetes care strategies that could improve future treatment approaches.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ensuring the safety of treatments for type 2 diabetes is crucial. For example, the TODAY clinical trial examined the safety of diabetes treatments for young people, assessing both serious and less serious side effects.

Methods that include close monitoring and support, like the extra care in this trial, aim to improve patient health without adding extra risk. This approach involves more frequent communication with healthcare providers and personalized support from a team. These methods are usually well-tolerated because they don't involve new drugs or invasive procedures.

For those considering joining a trial with extra care, it's important to know that this type of support is designed to help manage diabetes better with the assistance of a care team. There is no specific evidence of harm from this kind of support-focused treatment. Instead, it emphasizes proactive management, a common practice in diabetes care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Augmented Initial Type 2 Diabetes Care because it enhances standard care with proactive, intensive outreach and personalized support. Unlike usual care, which primarily involves basic counseling and treatment recommendations, this approach includes active engagement from a dedicated diabetes care team. Patients receive tailored self-management support from care managers, health educators, and dieticians, aiming to improve overall outcomes and empower patients to manage their diabetes effectively. This innovative approach seeks to offer a more comprehensive support system, potentially leading to better health management and improved quality of life for individuals with Type 2 diabetes.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research has shown that a well-organized and intensive approach to managing type 2 diabetes can lead to significantly better health outcomes than regular care. In this trial, participants in the Augmented Initial Type 2 Diabetes Care arm will receive enhanced support, which studies suggest can improve diabetes management. One study found that using enhanced data facilitated accurate tracking of changes in HbA1c levels, indicating better diabetes control. Another study demonstrated that this approach improved the body's insulin use to lower blood sugar. Additionally, research found that patients using advanced glucose monitoring had lower HbA1c levels after one year. These findings suggest that Augmented Initial Care can manage type 2 diabetes more effectively than standard methods. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for KPNC members aged 18-74 who have just been diagnosed with Type 2 Diabetes and are at risk of not controlling their blood sugar well early on. The study specifically looks for adults with certain age and HbA1c levels indicating they might struggle without extra help.

Inclusion Criteria

Kaiser Permanente Northern California member receiving care in a participating service area

I am under 45 and my HbA1c level is over 10%.

I have recently been diagnosed with type 2 diabetes.

Exclusion Criteria

Individuals who are pregnant

I likely have type 1 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Augmented Initial T2D Care or Usual Initial T2D Care, with proactive and intensive outreach for the experimental group

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of diabetes-related outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Augmented Initial Type 2 Diabetes Care

Trial Overview The trial compares two ways to start treating Type 2 Diabetes: usual care versus a more proactive approach that includes regular check-ins from the diabetes team. Participants will be randomly placed in one of these two groups to see which method leads to better health outcomes after 6 and 12 months.

How Is the Trial Designed?

Group I: Augmented Initial Type 2 Diabetes (T2D) Care Experimental Treatment 1 Intervention

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.

Group II: Usual Initial Type 2 Diabetes (T2D) Care Active Control 1 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.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

The Permanente Medical Group

Collaborator

Trials

2

Recruited

2,100+

Citations

1. withpower.com withpower.com/trial/phase-type-2-diabetes-t2d-3-2025-14f8c

Augmented Initial Care for Type 2 Diabetes The study on protocol-driven care showed that structured, intensive management of type 2 diabetes can improve clinical outcomes compared to usual care, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11794749/

AUGMENTed Real-World Data Enhances Comparative ... Using augmented data, the precision of the change in HbA1c estimate was increased compared with the trial stratum analysis alone. These findings ...

3. diabetesjournals.org diabetesjournals.org/care/article/47/4/571/154056/Impact-of-Insulin-Sensitivity-and-Cell-Function

Impact of Insulin Sensitivity and β-Cell Function Over Time on ... In this report, we analyze data from repeated oral glucose tolerance tests (OGTTs) to determine whether measures of insulin sensitivity and β-cell function over ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07148713

Pilot of Continuous Glucose Monitor-Augmented Food Is ... This study is designed to test the feasibility and preliminary efficacy of a CGM-augmented FIM intervention for adults with type 2 diabetes and nutrition or ...

5. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/dia.2016.0166

Clinical Outcomes After 1 Year of Augmented Insulin Pump ... The starting HbA1C was 8.7% ± 1.7% and 7.4% ± 0.8% (P < 0.05) 1 year later. 16.5% of patients had been admitted to the hospital before starting CSII-rtCGM, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10505357/

Advances in the Management of Diabetes Mellitus Diabetes mellitus poses a substantial global health challenge, necessitating innovative approaches to improve patient outcomes.

7. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S146/157557/7-Diabetes-Technology-Standards-of-Care-in

7. Diabetes Technology: Standards of Care in Diabetes—2025 In two of the studies, the primary outcome was a reduction in time spent in hypoglycemia, and rtCGM showed greater benefits compared with isCGM ...

8. liebertpub.com liebertpub.com/doi/10.1089/dia.2024.78502.abstracts.part2

ATTD 2025 Oral Abstracts | Diabetes Technology & ... The average reduction in HbA1c was 1.27±1.4% (p <0.001), fasting blood sugar (FBS) levels improved by 30.67±57.8 mg/dL (p <0.001), and weight decreased by 1.0± ...