Nurse Case Management for Diabetes

(MANAGe-DM Trial)

Overseen By Laura Hawks, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Disqualifiers: Dementia, Psychosis, Life expectancy <12 months, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study is a randomized control trial involving 100 participants (formerly incarcerated Black men with poorly controlled diabetes) to examine the effect of a tailored nurse case manager on glycemic control and other clinical outcomes, self-care behaviors, and quality of life at 6 months post-randomization.

Will I have to stop taking my current medications?

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

Is Nurse Case Management for Diabetes safe for humans?

Research on metformin, including its extended-release forms like Glucophage XR and Glumetza, shows it is generally safe for humans, with a good safety profile and well-tolerated in terms of gastrointestinal side effects. ^{1 2 3 4 5}

How is the drug MANAGe-DM different from other diabetes treatments?

MANAGe-DM, commonly known as metformin, is unique because it is often the first-line medication for type 2 diabetes, working by decreasing glucose production in the liver and improving insulin sensitivity. Unlike some other diabetes medications, it does not typically cause weight gain and is often used in combination with other treatments if additional glucose control is needed. ^{6 7 8 9 10}

What data supports the effectiveness of the drug MANAGe-DM and related medications for diabetes management?

Metformin, a key component of MANAGe-DM, is widely used as a first-line treatment for type 2 diabetes and is known for its effectiveness in controlling blood sugar levels. Additionally, combining metformin with other medications like DPP-4 inhibitors can enhance treatment outcomes for patients whose diabetes is not well-managed with metformin alone. ^{10 11 12 13 14}

Who Is on the Research Team?

Laura Hawks, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for Black men over 18 years old with poorly controlled type 2 diabetes (HbA1c ≥8%), who have been released from incarceration within the last year. They must be able to communicate in English and not be on house arrest or under electronic monitoring, involved in other diabetes trials, facing imminent legal proceedings, or have significant dementia or acute mental disorders.

Inclusion Criteria

Identify as Black or African American

You were in prison or jail in the last year.

I identify as male.

Exclusion Criteria

You are currently in another clinical trial for diabetes.

You have a severe mental illness or are currently experiencing a mental health crisis.

You seem very confused during the screening interview, which could mean you have serious memory problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive diabetes education mailings and nurse case management intervention, including monthly mailings and two phone call sessions per month

6 months

Monthly mailings, 2 phone call sessions per month

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life and blood pressure measurements

6 months

What Are the Treatments Tested in This Trial?

Interventions

• MANAGe-DM
• Monthly Educational Mailing

Trial Overview The MANAGe-DM study tests a tailored nurse case management approach versus monthly educational mailings to improve blood sugar control and quality of life in participants. It's a randomized trial with two groups: one receiving the novel intervention and the other standard information.

How Is the Trial Designed?

Group I: MANAGe-DM Experimental Treatment 1 Intervention

Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. MANAGe-DM will include NCM services tailored to the health needs of Black men with recent release from incarceration and T2DM. MANAGe-DM will include three components: 1) diabetes education and skills training; 2) healthcare navigation and 3) basic needs navigation. . Each month of the study period, the NCM will conduct two phone call intervention sessions with individual participants.

Group II: Control Active Control 1 Intervention

All participants in the study will receive diabetes education mailers. This includes monthly mailings of diabetes education, based off the American Diabetes Association guidelines for Diabetes Education.

MANAGe-DM is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Metformin for:

• Type 2 diabetes
• Polycystic ovary syndrome

Approved in United States as Metformin for:

• Type 2 diabetes

Approved in Canada as Metformin for:

• Type 2 diabetes
• Polycystic ovary syndrome

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

The treatment options for type 2 diabetes have expanded significantly over the past 20 years, now including 11 categories of medications, with DPP IV inhibitors (gliptins) being a notable recent addition.

Alogliptin, one of the DPP IV inhibitors, was approved for use in Japan in 2010 and is currently under FDA review, highlighting its potential as a new therapeutic option for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alogliptin for the treatment of type 2 diabetes. White, JR.[2017]

In a study of 2683 matched pairs of patients with type 2 diabetes, those treated with exenatide experienced a greater reduction in A1C levels (-0.6%) compared to those on insulin glargine (-0.4%), indicating better blood sugar control.

Exenatide also led to significant weight loss (-2.6 kg) and reductions in body mass index (BMI) and systolic blood pressure, suggesting additional health benefits beyond glucose management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic outcomes of matched patient populations initiating exenatide BID vs. insulin glargine in an ambulatory care setting. Pawaskar, M., Li, Q., Hoogwerf, BJ., et al.[2022]

In a study of 6,758 matched patients with type 2 diabetes, those on DPP-4 inhibitors showed slightly better adherence (65.5%) and persistence (52.5%) compared to those on sulfonylureas (63.3% adherence and 48.0% persistence) over 12 months.

Patients on sulfonylureas were more likely to remain untreated after discontinuation of their initial therapy, while those on DPP-4 inhibitors were more likely to use multiple oral antidiabetic drugs, indicating different treatment progression patterns between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment progression in sulfonylurea and dipeptidyl peptidase-4 inhibitor cohorts of type 2 diabetes patients on metformin. Peng, X., Jiang, D., Liu, D., et al.[2020]

The case vignette provides a patient-centered approach to selecting diabetes treatments, highlighting the importance of considering individual patient needs when choosing between oral agents, basal insulin, or GLP-1 receptor agonists.

It emphasizes the role of newer GLP-1 receptor agonists as a potential option, suggesting they may offer benefits in managing diabetes alongside traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What next when metformin isn't enough for type 2 diabetes? Hawes, EM., Wehby, J., Mounsey, A.[2022]

As patients with type 2 diabetes increasingly require insulin therapy after oral medications fail, international guidelines recommend starting with basal insulin while continuing metformin to help manage blood sugar levels.

When basal insulin alone does not achieve glycemic targets, options include switching to a more intensive insulin regimen, adding another oral medication like a DPP-4 inhibitor or SGLT-2 inhibitor, or combining basal insulin with a GLP-1 receptor agonist, each with its own benefits and drawbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimizing basal insulin therapy in type 2 diabetes]. Scheen, AJ., Paquot, N.[2018]

In two studies involving a total of 982 patients, metformin XR significantly reduced HbA1C levels compared to placebo, demonstrating its efficacy in improving glycemic control in patients with inadequate management despite diet and exercise.

A clear dose-response relationship was observed, with higher doses of metformin XR leading to greater reductions in HbA1C, and the medication was well tolerated, with minimal withdrawals due to gastrointestinal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, dose-response relationship and safety of once-daily extended-release metformin (Glucophage XR) in type 2 diabetic patients with inadequate glycaemic control despite prior treatment with diet and exercise: results from two double-blind, placebo-controlled studies. Fujioka, K., Brazg, RL., Raz, I., et al.[2022]

In a study of 14,512 patients with type 2 diabetes, those treated with sulphonylureas (SUs) and thiazolidinediones (TZDs) experienced significantly more adverse events (AEs) compared to those treated with metformin (MET), with rates of 15.9% and 19.8% respectively, versus 8.6% for MET.

While AEs did not significantly affect overall glycaemic control (A1C levels), they did influence treatment patterns, leading to more patients on MET and SU switching therapies or adding additional treatments after experiencing AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between oral antidiabetic use, adverse events and outcomes in patients with type 2 diabetes. Asche, CV., McAdam-Marx, C., Shane-McWhorter, L., et al.[2022]

Dulaglutide, a GLP-1 analog approved for type 2 diabetes, has shown significant therapeutic benefits, including weight reduction, decreased progression of nephropathy, and lower incidence of myocardial infarction, based on an analysis of 25 studies from 2014 to 2018.

Despite its benefits, Dulaglutide is associated with potential risks such as septicemia, malignant neoplasm, coronary artery disease, and pancreatic cancer, highlighting the need for ongoing safety monitoring by regulatory authorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and Benefit Profile of Dulaglutide in Established Therapeutic Indication. Garg, A., Kumar, A.[2019]

In a study of 126 overweight and obese patients with type 2 diabetes, dulaglutide (DU) showed a significant and sustained reduction in HbA1c levels over 18 months, with a mean decrease of -0.85% at 6 months, indicating its effectiveness as an add-on therapy to metformin.

Dulaglutide was associated with a higher percentage of patients achieving glycemic targets (HbA1c ≤ 7.0%) compared to liraglutide (LIRA) at 18 months, with 64.8% of DU patients reaching this target versus 42.6% for LIRA, highlighting its potential as a more effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness and Safety of Once-Weekly GLP-1 Receptor Agonist Dulaglutide as Add-On to Metformin or Metformin Plus Insulin Secretagogues in Obesity and Type 2 Diabetes. Mirabelli, M., Chiefari, E., Tocci, V., et al.[2021]

Metformin extended release (Glumetza) has been shown to significantly lower glycosylated hemoglobin levels in patients with type 2 diabetes, demonstrating efficacy comparable to immediate-release metformin, based on two pivotal phase III trials involving over 1000 patients.

The extended-release formulation was well tolerated, exhibiting an excellent safety profile with minimal gastrointestinal side effects, making it a promising option for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metformin extended release--DepoMed: metformin, metformin gastric retention, metformin GR. [2018]

The review highlights the need for a shift in diabetes management practices to better engage patients, emphasizing the importance of patient partnership in enhancing self-management and clinical outcomes.

Numerous evidence-based models and strategies are available to improve diabetes care, suggesting that nurse practitioners can play a crucial role in implementing these best practices for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partnering with patients to promote holistic diabetes management: changing paradigms. Lorenzo, L.[2013]

A 6-month nurse case manager (NCM) intervention significantly improved glycemic control in adults with type 2 diabetes, resulting in a reduction of A1C levels by -0.73% compared to standard care.

The NCM intervention also reduced diabetes distress scores by 26%, indicating that it not only helps with blood sugar management but also supports patients' emotional well-being, making it a valuable addition to standard diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Nurse Case Management in a Canadian Tertiary Care Setting: Results of a Randomized Controlled Trial. Li, D., Elliott, T., Klein, G., et al.[2018]

In a randomized controlled trial involving 556 veterans with diabetes, nurse case management significantly improved the control of hypertension, hyperglycemia, and hyperlipidemia, with 21.9% of patients achieving all three targets compared to only 10.1% in the usual care group.

The intervention also led to better individual outcomes for blood pressure and hemoglobin A1c levels, indicating that structured case management can enhance overall cardiovascular risk factor management in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nurse case management compared with usual care on controlling cardiovascular risk factors in patients with diabetes: a randomized controlled trial. Ishani, A., Greer, N., Taylor, BC., et al.[2022]

Implementing standing orders for nurse case managers to adjust antihyperglycemic medications led to the most rapid improvement in glycemic control among patients with diabetes, despite a higher incidence of hypoglycemia in this group.

Overall, hypoglycemia was infrequent across all treatment groups, indicating that nurse case management, with or without medication adjustments, is a safe and effective approach to enhance diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of medication adjustments by nurse case managers to control hyperglycemia. Curtis, J., Lipke, S., Effland, S., et al.[2019]

Citations

1. Spain pubmed.ncbi.nlm.nih.gov

Alogliptin for the treatment of type 2 diabetes. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Metabolic outcomes of matched patient populations initiating exenatide BID vs. insulin glargine in an ambulatory care setting. [2022]

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

Treatment progression in sulfonylurea and dipeptidyl peptidase-4 inhibitor cohorts of type 2 diabetes patients on metformin. [2020]

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

What next when metformin isn't enough for type 2 diabetes? [2022]

5. Belgium pubmed.ncbi.nlm.nih.gov

[Optimizing basal insulin therapy in type 2 diabetes]. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy, dose-response relationship and safety of once-daily extended-release metformin (Glucophage XR) in type 2 diabetic patients with inadequate glycaemic control despite prior treatment with diet and exercise: results from two double-blind, placebo-controlled studies. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Association between oral antidiabetic use, adverse events and outcomes in patients with type 2 diabetes. [2022]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Risk and Benefit Profile of Dulaglutide in Established Therapeutic Indication. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness and Safety of Once-Weekly GLP-1 Receptor Agonist Dulaglutide as Add-On to Metformin or Metformin Plus Insulin Secretagogues in Obesity and Type 2 Diabetes. [2021]

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

Metformin extended release--DepoMed: metformin, metformin gastric retention, metformin GR. [2018]

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

Partnering with patients to promote holistic diabetes management: changing paradigms. [2013]

12. Canada pubmed.ncbi.nlm.nih.gov

Diabetes Nurse Case Management in a Canadian Tertiary Care Setting: Results of a Randomized Controlled Trial. [2018]

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

Effect of nurse case management compared with usual care on controlling cardiovascular risk factors in patients with diabetes: a randomized controlled trial. [2022]

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

Effectiveness and safety of medication adjustments by nurse case managers to control hyperglycemia. [2019]