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

204 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Augmented Initial Type 2 Diabetes 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, suggesting that a similar approach in Augmented Initial Type 2 Diabetes Care might be effective. ^{1 2 3 4 5}

Is the treatment for type 2 diabetes generally safe for humans?

The TODAY clinical trial assessed the safety of treatments for type 2 diabetes in young people, noting severe and nonsevere adverse events. Additionally, a study on second-line diabetes medications found varying rates of hypoglycemia (low blood sugar) and acute metabolic complications, suggesting that safety can differ depending on the specific medication used. ^{6 7 8 9 10}

How is the Augmented Initial Type 2 Diabetes Care treatment different from other treatments for type 2 diabetes?

This treatment is unique because it involves using a combination of drugs early in the treatment process, rather than starting with a single drug like metformin and adding others later. This early combination approach aims to better control blood sugar levels, slow down the progression of the disease, and improve long-term outcomes for patients. ^{1 11 12 13 14}

Eligibility Criteria

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 am between 18 and 74 years old.

Exclusion Criteria

Individuals who are pregnant

I likely have type 1 diabetes.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Cardiovascular risk reduction following diagnosis of diabetes by screening: 1-year results from the ADDITION-Cambridge trial cohort. [2023]

2. Argentina pubmed.ncbi.nlm.nih.gov

[Type 2 diabetes. Is it possible to achieve the glycemic goal in real life?] [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical predictors of disease progression and medication initiation in untreated patients with type 2 diabetes and A1C less than 7%. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Six-month outcomes on A1C and cardiovascular risk factors in patients with type 2 diabetes treated with exenatide in an ambulatory care setting. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of protocol-driven care versus usual outpatient clinic care on survival rates in patients with type 2 diabetes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of the treatment of youth-onset type 2 diabetes: the TODAY experience. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Glycemic Outcomes of Second-Line Diabetes Drug Choice in a Real-World Population. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Once-weekly dulaglutide versus insulin glargine in the early control of fasting serum glucose and HbA1c. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Association Between Insulin Initiation and Adverse Outcomes After Hospital Discharge in Older Adults: a Population-Based Cohort Study. [2020]

10. England pubmed.ncbi.nlm.nih.gov

A real world comparison of sulfonylurea and insulin vs. incretin-based treatments in patients not controlled on prior metformin monotherapy. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Early combination therapy for the treatment of type 2 diabetes mellitus: systematic review and meta-analysis. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Long-term Trends in Antidiabetes Drug Usage in the U.S.: Real-world Evidence in Patients Newly Diagnosed With Type 2 Diabetes. [2018]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

Evaluating the Evidence behind the Novel Strategy of Early Combination from Vision to Implementation. [2023]

14. New Zealand pubmed.ncbi.nlm.nih.gov

Third-Line Antidiabetic Therapy Intensification Patterns and Glycaemic Control in Patients with Type 2 Diabetes in the USA: A Real-World Study. [2022]