What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include lifestyle modifications, oral glucose-lowering drugs, and insulin. Lifestyle changes, such as diet and exercise, generally have minimal side effects but can be challenging to maintain. Oral medications like metformin may cause gastrointestinal issues, including nausea and diarrhea. Sulphonylureas can lead to hypoglycemia and weight gain. Insulin therapy, while effective, carries risks of hypoglycemia and potential weight gain. Newer agents like GLP-1 receptor agonists may cause gastrointestinal symptoms such as nausea but have shown promise in weight management.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes, including glucagon-like peptide-1 (GLP-1) receptor agonists such as exenatide and dulaglutide. Exenatide, available in both extended-release (Bydureon BCise) and shorter-acting formulations (Byetta), has shown efficacy in improving glycemic control. Dulaglutide, another GLP-1 receptor agonist, has also been approved for weekly administration. These medications not only help in managing blood glucose levels but also support patient engagement in self-care activities by offering convenient dosing schedules and additional benefits such as weight management.

What other types of research exist?

Promising novel alternatives for Type 2 Diabetes education include Web-based self-management programs, Diabetes Conversation Maps™, and community-based lifestyle intervention programs. These methods have shown efficacy in improving patient knowledge, engagement in self-care, and glycemic control.

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Diabetes Self-Management Education for Reproductive-Aged Women With Type 2 Diabetes (PREPARED Trial)

N/A

Recruiting

Led By Stacy Bailey, PhD MPH

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female

Age 18-44

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 month and 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the PREPARED strategy, which uses technology to help reproductive-aged women with type 2 diabetes manage their health and plan for pregnancy. It aims to improve their knowledge and engagement in self-care activities by using electronic records, printed materials, and text messages.

Who is the study for?

This trial is for women aged 18-44 with type 2 diabetes who are not currently pregnant, can get pregnant, and aren't in a relationship with someone unable to have children. They must speak English or Spanish, be able to consent, and have a private cell phone that can send texts.

What is being tested?

The study tests if certain tools like provider alerts, decision support systems, medication reconciliation tools (MedRec), PREPSheets for planning pregnancy care, and text messaging improve knowledge and self-care in reproductive-aged women with type 2 diabetes.

What are the potential side effects?

Since this trial involves educational tools rather than medications or invasive procedures, side effects may include discomfort from frequent communication or potential privacy concerns related to text messaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

Select...

I am between 18 and 44 years old.

Select...

I have been diagnosed with type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 month and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 month and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average difference in HbA1c values between Intervention and Control Patients

Knowledge of reproductive risks

Secondary study objectives

Average difference in blood pressure values between Intervention and Control Patients

Average difference in cholesterol values between Intervention and Control Patients

Contraceptive use

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: PREPARED StrategyActive Control4 Interventions

Our PREPARED strategy will utilize health information and consumer technologies to 'hardwire' preconception care and promote diabetes self-management among reproductive-aged, adult women with T2DM in primary care. PREPARED will leverage electronic health record technology at clinic visits to: \[1\] promote medication reconciliation and safety, \[2\] prompt provider preconception counseling, and \[3\] deliver low literacy print tools to reinforce counseling and promote diabetes self-care. Post-visit, text messaging will be used to: \[4\] encourage healthy lifestyle behaviors.

Group II: Usual CareActive Control1 Intervention

Usual care includes: 1) no specific materials to promote medication reconciliation, reproductive planning, or patient education on diabetes self-management within the context of preconception care, 2) variable physician preconception counseling without any EHR notifications or counseling support; and 3) no specific patient support or prompts to promote healthy behaviors post-visits.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 2 Diabetes include lifestyle interventions, metformin, insulin, GLP-1 receptor agonists, and SGLT2 inhibitors. Lifestyle interventions, such as diet and exercise, improve insulin sensitivity and glycemic control. Metformin reduces hepatic glucose production and increases insulin sensitivity. Insulin therapy directly lowers blood glucose levels by facilitating cellular glucose uptake. GLP-1 receptor agonists enhance insulin secretion and inhibit glucagon release, while SGLT2 inhibitors reduce glucose reabsorption in the kidneys, leading to increased glucose excretion. These treatments are crucial for managing Type 2 Diabetes as they address different aspects of the disease's pathophysiology. Educational programs that improve patient knowledge and engagement in self-care activities are essential, as they empower patients to effectively manage their condition and adhere to treatment regimens.

Group based training for self-management strategies in people with type 2 diabetes mellitus.