Results Summary
What was the research about?
When a person has type 1 diabetes, their body doesn’t make the hormone insulin. The body needs insulin to get blood sugar into cells. Keeping blood sugar levels normal can help prevent health problems that affect the heart, brain, eyes, limbs, and kidneys. People usually develop type 1 diabetes as children or young adults.
Decision aids help people choose between two or more healthcare options taking into account what is most important to them. In this study, the research team created online decision aids for two treatment devices:
- Insulin pump, a small device worn outside of the body that delivers insulin through a tube that runs under the skin
- Continuous glucose monitor, a sensor under the skin that tells patients if their blood sugar is too high or low
The research team wanted to help youth with type 1 diabetes and their parents make decisions about using the devices. They compared a group that viewed one or both decision aids with a group that didn’t view the decision aids.
What were the results?
After one year, the two groups didn’t differ in skill in using the treatment devices. Of youth who started using one of the devices during the study, 32 percent viewed the decision aids and 37 percent didn’t.
The two groups didn’t differ in
- Blood sugar levels
- How often patients had low blood sugar
- Knowledge about treatment devices
- How youth and their parents made decisions
Compared with parents who didn’t view the decision aids, those who did reported that their children followed their diabetes treatment plan more closely.
Who was in the study?
The study included 133 patients ages 11–17 with type 1 diabetes; each patient was paired with a parent. Of the patients, 78 percent were white, 8 percent were African American, and 2 percent were Asian. The average age was 14, and 51 percent were boys. Patients received care from clinics in Delaware, Florida, and Colorado.
What did the research team do?
To create the decision aids, the research team interviewed 53 pairs of youth with type 1 diabetes and their parents. The team also interviewed 12 doctors, nurses, and psychologists. The interviews asked how patients make decisions about devices and what content the decision aids should include. The final decision aids reviewed
- Treatment options
- Possible treatment results
- How to decide what is most important to the patient
- How to make and discuss treatment decisions
The research team then assigned other patient-parent pairs by chance to view or not view the online decision aids. Patient-parent pairs in the decision-aid group chose whether they received one or both decision aids. After viewing the decision aids, patient-parent pairs met with a diabetes educator. The educator coached them on how to discuss questions with their doctors. Those who didn’t view the decision aids received regular diabetes education and counseling from their doctor.
Patients and parents took surveys at the start of the study and at follow-up visits every three months for a year.
Youth with type 1 diabetes and their parents gave feedback to the research team during the study.
What were the limits of the study?
Many patients and parents in the study already knew a lot about the treatment devices. This knowledge may have reduced the study’s chances to find changes.
Future research could continue to look for ways to help youth with type 1 diabetes and their parents make decisions about treatment devices.
How can people use the results?
Clinics can use these results when considering ways to improve the health of youth with type 1 diabetes.
Professional Abstract
Objective
To compare the effectiveness of treatment device decision aids with usual care among patients with type 1 diabetes and their parents on improving the use of treatment devices, health outcomes, and the decision-making process
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 133 patients ages 11–17 with type 1 diabetes and their parents |
| Interventions/ Comparators |
|
| Outcomes |
Primary: proficiency of use of insulin pump or continuous glucose monitoring Secondary: treatment adherence, HbA1c levels, frequency of severe hypoglycemia, insulin pump or continuous glucose monitoring knowledge, decision-making process |
| Timeframe | 1-year follow-up for primary outcome |
This randomized controlled trial evaluated the effectiveness of two decision aids in helping adolescents and their parents decide whether to add an insulin pump or continuous glucose monitoring to their type 1 diabetes treatment. Decision aids are tools to help people make informed choices, consistent with their values, among healthcare options. To create the web-based decision aids, researchers interviewed 53 pairs of adolescent patients with type 1 diabetes and their parents and 12 clinicians. Researchers asked about the decision-making process and what should be covered in the decision aids. The final decision aids, one for each device, included
- Information on patient options and outcome probabilities
- Activities to help participants clarify their values and preferences
- Guidance on deliberation and communication
Researchers then randomly assigned 133 patients ages 11–17 with type 1 diabetes, paired with a parent, to either the decision aid or usual care group. Because the treatment devices are not mutually exclusive, pairs in the decision aid group chose whether they received one or both decision aids. Patients and parents in the decision aid group reviewed their decision aids and then met with a diabetes educator. The educator helped the pairs identify any remaining uncertainties about their decision and coached them on how to discuss these uncertainties with their healthcare providers. The usual care group received routine education and counseling from their healthcare providers.
Among patients, 78% were white, 8% were African American, and 2% were Asian. The average age was 14, and 51% of patients were male. Patients received care from clinics in Delaware, Florida, and Colorado.
Researchers administered surveys at the start of the study and again at four quarterly follow-up visits. The surveys asked about treatment device use and knowledge, overall treatment adherence, HbA1c levels, frequency of severe hypoglycemia, and the decision-making process.
Adolescent patients with type 1 diabetes and their parents provided feedback throughout the study.
Results
After one year, the decision aid and usual care groups did not differ in proficiency of use of insulin pumps or continuous glucose monitoring. During the study, 32% of the decision aid group and 37% of the usual care group started using either treatment device.
Parents in the decision aid group reported higher overall treatment adherence (p>0.05) than parents in the usual care group. The two groups did not differ in any other secondary outcome.
Limitations
Many patients and parents in the study already had a high level of knowledge about the advantages and disadvantages of insulin pumps and continuous glucose monitoring. This knowledge may have affected the study’s ability to detect differences in outcomes.
Conclusions and Relevance
The study did not find evidence to suggest that the decision aids were more effective than usual care in helping adolescent patients with type 1 diabetes and their parents make decisions about treatment devices.
Future Research Needs
Future research could continue to explore interventions for helping patients with type 1 diabetes and their parents make treatment device decisions.
Final Research Report
View this project's final research report.
Journal Citations
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Reviewers asked the researchers to explain the results in the context of existing knowledge. The researchers replied that this was difficult because there had been no past rigorous randomized controlled trials about the effects of shared decision-making interventions in pediatrics, particularly involving patients with pediatric type 1 diabetes. There have also been no similar efforts to develop multimedia decision aids with these populations.
- Reviewers asked for additional emphasis on demographic and other factors that could have moderated the effects of the shared decision-making intervention. The researchers said since they did not observe any treatment effects they could not analyze subgroup effects.
- Reviewers asked if sample size could have affected the study’s power to detect treatment effects. The researchers said that in the absence of positive treatment effects, they could not expect to see different results even in a very large sample.