Education Strategies for Safer Medication Use in Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
Overseen byIan Neeland, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Hospitals Cleveland Medical Center
Must be taking: Sulfonylureas
Disqualifiers: Type 1 diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Sulfonylurea medications are unsafe for older patients with diabetes. They are associated not only with hypoglycemia, but also with falls and increased cardiovascular risk. Yet they continue to be prescribed frequently. Indeed, older adults with type 2 diabetes, who are especially prone to adverse effects, are more likely to be prescribed sulfonylureas than younger patients. This is unfortunate since over the past several years, newer, safer, and more effective classes of medications (GLP-1 agonists and SGLT2-inhibitors) have emerged. The investigators acknowledge that sulfonylureas are inexpensive and that their low cost is a driver of continued use. However, the investigators believe patients and providers should have discussions about the risks of sulfonylureas and safer and more effective alternatives, to make diabetes care safer overall in ambulatory settings. Our research is designed to promote such discussions. The investigators will first identify patients taking sulfonylureas regularly. Next, using recommendations from AHRQ and the Canadian Deprescribing Network, the investigators will empower patients to discuss their medications with their providers through a simple question prompt sheet. Patients will be divided into an intervention group which receives explicit prompting questions, and a control group that receives a general brochure on diabetes medications. Health care providers will receive education about newer diabetes medications through case-based discussions and academic detailing. Finally the investigators will measure key outcomes including the proportion of patients who have discussions about sulfonylureas and alternatives, rates of discontinuation, and measures of control of diabetes and associated cardiovascular risks. The investigators will also evaluate the experiences of patients and providers qualitatively through brief, semi-structured interviews. Should our multi-faceted, patient-oriented intervention prove effective in promoting discussions of sulfonylureas and alternatives, and also discontinuation of sulfonylureas and switching to newer alternatives, the investigators will incorporate our prompting questions into routine care for patients taking sulfonylureas. Our intervention can be easily disseminated to other settings and therefore has considerable potential to improve safety among patients with type 2 diabetes nationwide.
Will I have to stop taking my current medications?
The trial focuses on encouraging discussions about switching from sulfonylurea medications to newer alternatives. It does not specify if you must stop your current medications, but it aims to promote safer options.
What data supports the effectiveness of the drug Farxiga (dapagliflozin) for safer medication use in type 2 diabetes?
Research shows that Farxiga (dapagliflozin) helps lower blood sugar levels and body weight in people with type 2 diabetes, and it is generally well tolerated. It also reduces the risk of kidney problems and heart-related issues in people with chronic kidney disease, even if they don't have diabetes.
12345Is dapagliflozin safe for humans?
Dapagliflozin, also known as Farxiga or Forxiga, is generally well tolerated in humans for the treatment of type 2 diabetes, with a low risk of low blood sugar (hypoglycemia) and common side effects like genital infections. It is not recommended for people with moderate or severe kidney problems.
12456How does this educational treatment for Type 2 diabetes differ from other treatments?
This treatment focuses on education strategies to improve medication adherence and self-management in Type 2 diabetes, which is different from traditional drug treatments. It aims to empower patients with knowledge to better manage their condition, potentially leading to improved glycemic control and reduced hospitalizations.
7891011Eligibility Criteria
This trial is for adults aged 45 and older with type 2 diabetes who have been seeing their primary care provider since at least 2021, are currently prescribed sulfonylurea medications, and can discuss medication changes with their doctor. It excludes those whose doctors advise against participation or who cannot give informed consent.Inclusion Criteria
I am currently taking medication for diabetes.
Established care (≥2 visits) with UH primary care provider (PCP) since 2021
I am 45 years old or older.
+1 more
Exclusion Criteria
I have Type 1 diabetes.
I am unable to understand and give consent for treatment.
PCP provides a reason why patient participation is inappropriate (e.g., known cost barriers without any alternatives, prior discussion with patient about alternatives, etc.)
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants are divided into an intervention group receiving a question-prompt sheet and a control group receiving a general brochure on diabetes medications. Primary care providers receive education about newer diabetes medications.
12 months
Up to 2 visits (in-person) for provider education
Follow-up
Participants are monitored for discussions about sulfonylureas and alternatives, discontinuation rates, and clinical outcomes such as Hb A1c, blood pressure, and lipid levels.
12 months
Surveys every 3 months
Participant Groups
The study tests whether using a prompt-sheet to encourage patient-doctor discussions about the risks of sulfonylureas (a diabetes drug) leads to switching to safer alternatives. One group gets prompting questions; another gets general info. Doctors also learn about newer drugs.
2Treatment groups
Experimental Treatment
Active Control
Group I: Prompt-sheetExperimental Treatment1 Intervention
Question-prompt group patients will receive a simple prompt sheet with the questions with which they will encouraged to use to guide a conversation with their provider at their next visit for routine diabetes care. These questions are based on recommendations from the Agency for Healthcare Research and Quality's Question Builder App and also on recommendations from the Canadian Deprescribing Network which specifically addresses SU use.
Group II: Usual educationActive Control1 Intervention
Control group patients will be sent an information brochure with content from the NIDDK about diabetes medications (https://www.niddk.nih.gov/health-information/diabetes/overview/insulin-medicines-treatments).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Hospitals Cleveland Medical CenterCleveland, OH
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Who Is Running the Clinical Trial?
University Hospitals Cleveland Medical CenterLead Sponsor
Ian J. Neeland, MDLead Sponsor
American Heart AssociationCollaborator
References
Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. [2021]To review clinical evidence for the efficacy, safety, and tolerability of dapagliflozin (Farxiga-AstraZeneca), a sodium glucose cotransporter 2 inhibitor, as monotherapy or in combination with other hypoglycemic agents for the treatment of type 2 diabetes.
Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. [2021]Dapagliflozin (DAPA) (Farxiga or Forxiga) is a sodium glucose cotransporter 2 (SGLT2) inhibitor approved for type 2 diabetes mellitus(T2DM) treatment.
Dapagliflozin (Forxiga) for type 2 diabetes? [2021]In the UK, diabetes mellitus affects around 3 million people, of whom over 90% have type 2 diabetes. Aims of treatment include minimising long-term complications (e.g. cardiovascular disease, blindness, chronic kidney disease, premature mortality) and avoiding unwanted effects of treatment (e.g. severe hypoglycaemia, weight gain). Management of diabetes includes patient support and education; addressing symptoms; lifestyle modification; targeting associated risk factors for cardiovascular disease; and surveillance for, and management of, complications including treatment-related hypoglycaemia. Dapagliflozin (Forxiga) belongs to a new class of oral glucose-lowering drugs that inhibit renal glucose reabsorption and promote glycosuria. It is licensed in the UK in adults with type 2 diabetes as monotherapy when diet and exercise alone do not provide adequate glycaemic control and who are unable to tolerate metformin; or, as add-on therapy, with other glucose-lowering agents including insulin, when these, with diet and exercise, do not provide adequate glycaemic control. The company's advertising materials claim that dapagliflozin provides a "novel method of controlling excess glucose" with "secondary benefit of weight loss". Here, we review the evidence for the use of dapagliflozin in the management of type 2 diabetes mellitus.
Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. [2023]Dapagliflozin (Farxiga) is now approved to reduce the risk of declining kidney function, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease with or without type 2 diabetes.
Dapagliflozin: a review of its use in patients with type 2 diabetes. [2022]Dapagliflozin (Forxiga(®), Farxiga(®)) is an orally administered sodium-glucose co-transporter-2 (SGLT2) inhibitor used in the management of patients with type 2 diabetes. Dapagliflozin reduces renal glucose reabsorption by inhibiting the transporter protein SGLT2 in the renal proximal tubule, thereby increasing urinary glucose excretion and reducing blood glucose levels. Its mechanism of action is independent of insulin secretion or action; therefore, dapagliflozin provides complementary therapy when used in combination with other antihyperglycaemic drugs. This article updates an earlier review of dapagliflozin and focuses on longer-term efficacy and tolerability data (e.g. from extensions of earlier clinical trials), as well as data from studies in special patient populations (e.g. history of cardiovascular disease). Numerous well-designed clinical trials with dapagliflozin, primarily as add-on therapy for 24 weeks (but also as monotherapy or initial combination therapy), have consistently demonstrated reductions in glycosylated haemoglobin, fasting plasma glucose levels and bodyweight. Extensions of these trials show the effects are maintained over longer-term follow-up periods of ≈1-4 years and dapagliflozin is generally well tolerated. Dapagliflozin has a low risk of hypoglycaemia, although the incidence varies depending on background therapy, and genital mycotic infections (particularly in women) are the most common adverse events. Dapagliflozin is not recommended in patients with moderate or severe renal impairment. In view of its unique mechanism of action and now well-established efficacy and tolerability profile, dapagliflozin is a useful treatment option in the management of type 2 diabetes, although its effects on diabetic complications remain to be evaluated.
Dapagliflozin no longer licensed for type 1 diabetes. [2022]Overview of: Medicines and Healthcare products Regulatory Agency. Dapagliflozin (Forxiga): no longer authorised for treatment of type 1 diabetes mellitus. Drug Safety Update 2021;15:3.
Diabetes knowledge, medication adherence and glycemic control among patients with type 2 diabetes. [2022]Most of interventions that have attempted to improve medication adherence in type 2 diabetes have been educational; on the assumption that knowledge regarding diabetes might affect patients' adherence to their treatment regimen.
Effectiveness of educational interventions to promote oral hypoglycaemic adherence in adults with Type 2 diabetes: a systematic review. [2020]Background As a chronic condition, the prevalence of Type 2 diabetes is increasing worldwide and adherence to oral medications, an essential component of self-management, has been shown to improve glycaemic control. However compliance with oral medication adherence remains poor. Educating people with Type 2 diabetes is an important strategy to enhance self-management ability, including medication-taking behaviour.Objectives The overall objective of the review was to determine the effectiveness of educational interventions to promote oral hypoglycaemic adherence in adults with Type 2 diabetes.
Diabetes education: looking through the kaleidoscope. [2013]Diabetes self-management education (DSME) is a critical element of care for all people with diabetes and those at risk for developing diabetes. In spite of growing evidence of the value of DSME in reducing hospitalization costs, improvement in glucose, weight and medication adherence, DSME remains an underutilized insurance benefit and access to qualified diabetes educators is problematic.
[Educational program to type 1 diabetes mellitus patients: basic topics]. [2022]Type 1 diabetes incidence has been increasing worldwide, however the vast majority of patients do not have a good glycaemic control. This review focuses on diabetes educational programs designed for children, young adults and their families, as well as regular pump users educational tips, collected from papers published between 2000 and 2007. A comprehensive review of the literature has identified 40 articles describing the methods and the evaluation of diabetes self-management education interventions. Three research questions are posed. First: what are the recommendations and standards for diabetes self-management education from the different diabetes institutions/associations? Second: is there sufficient evidence to recommend any adaptation of any particular program? And third: Are the educational programs effective in lowering glycated haemoglobin (HbA1c)? The patient and his family should be instructed and trained to take appropriate decisions for diabetes management regarding their daily care. Diabetes self-management education improves glicaemic control (both in an individual basis as well as in groups) in such a way that the longer the education training in diabetes the better is the effect on glycaemic control is.
[Follow-up, therapeutic education, and pharmacologic treatments of patients with type 2 diabetes. Various critical views]. [2007]Several factors have to be taken into account for successful therapeutic patient education: patients' acceptance of the illness; an interactive educational process, the inclusion of therapeutic objectives in the short, medium and long-term which should be planned with the patient. There are numerous facets in the treatment of diabetes, but the common denominator is the dietary programme coupled with daily physical activity. This is the condition sine qua non to be included before the introduction of any pharmacological treatment. The benefits of this latter treatment are: 1) insulin substitution with insulin analogue responding especially quickly, thereby stopping the glycaemic level from falling; 2) insulin secretagogues (Sulfonylurea, Glinides, [Novonorm, Starlix]); 3) agents which raise the sensibility to insulin (glitazones, [Avandia], biguanides); 4) molecules which interfere with the absorption of the glucose at the digestive level (biguanides and alphaglucosidase inhibitors).