Read Suggested Topics for Research | AHRQ Effective Health Care Program

Topic Suggestion Description

Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.: For patients - including both children and adult subgroup comparisons - with type 1 diabetes, what is the comparitive differences in HbA1c levels when comparing various treatment options including multiple daily injections, insulin pump therapy, daily injections with continuous glucose monitoring, and insulin pump therapy with continuous glucose monitoring?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.): yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:: Treatment: 1. Multiple daily injections only. 2. Insulin pump therapy only. 3. Multiple daily injections with continuous glucose monitoring. 4. Insulin pump therapy with continuous glucose monitoring.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.): Groups of patients include: 1. All people with type 1 diabetes 2. Children with type 1 diabetes 3. Adults with type 1 diabetes

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.): Insurance companies are still fighting against covering insulin pump therapy in addition to continuous glucose monitoring. I am interested in a study that either proves or negates the benefits of this technology. Insulin pump therapy provides 24-hour steady insulin delivery as opposed to long-lasting insulin which can vary due to injection site, body mechanics affecting duration of effects and absorption, and patient error (forgetting to inject or not using the correct dose). Continuous glucose monitoring, while still in its early stages, can provide useful information for trending in glucose levels. Nightime variables causing nocturnal hypoglycemia and/or dawn phenomenon; and changes such as activity levels, sleep and/or work/school schedules, seasonal changes, and periods of illness or stress, can be closely monitored and recorded with CGM technology. This can lead to tighting insulin dosing and better blood glucose control.

Describe any health-related risks, side effects, or harms that you are concerned about.: Insurance companies not providing benefits to the population diagnosed with type 1 diabetes may spend more money in the future due to long-range consequences from uncontrolled type 1 diabetes. High blood glucose levels damage many areas of the body such as the heart, kidneys, eyes, and nerves while Low blood glucose levels can cause seizures and death.

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?: yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

AHRQ Priority Populations

Low income groups
Minority groups
Women
Children
Elderly
Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

Describe why this topic is important.: Insurance and coverage for this technology should be made available to anyone who may benefit from this treatment. Premium healthcare plans only require a doctor's prescription to supply these items, whereas Medicare and Medicaid does not recognize the CGM technology therefore they will not provide benefits for these services. Medicare and many Medicaid programs will only provide coverage of an insulin pump for people with type 1 diabetes but even then, these individuals are forced to undergo certain blood tests to prove their diagnosis (positive beta cell autoantibody and/or qualifying c-peptide lab results).

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.): I work for a diabetic supply company and I have seen hundreds of clients that were using insulin pump therapy for many years have to stop using this treatment and go back to multiple daily injections. The private, employer-sponsored insurance paid for the pump with a prescription from their treating physician but once they retired, Medicare required a fasting blood test showing they are producing little to no insulin. Not only can fasting be dangerous for person with diabetes, a laboratory technician assigning a range and creating a result from this antiquated test is insulting to these people that have worked long and hard only to retire and have Medicare say they are not "diabetic enough" to have Medicare pay for them continue using an insulin pump.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.): yes
If yes, please explain:: I have dealt with very angry physicians who feel unable to treat their patients due to regulations that end up harming the health of people with diabetes. The variations in clinical care - prescribing an insulin pump for a blind person who has type 2 diabetes and cannot self-administer syringes of insulin or not having a CGM in place to alarm the caretakers of a two-year-old child about to experience a nocturnal hypoglycemic episode because he is covered by a Medicaid plan is unethical, immoral, and discriminating.

How will an answer to your research question be used or help inform decisions for you or your group?: I could use this information to change the policies of these insurance groups and get the latest technology for everyone who can benefit from this type of treatment.

Describe the timeframe in which an answer to your question is needed.: The quicker the better because people are suffering from complications due to uncontrolled diabetes and more and more people are getting diagnosed every day.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.: Our retired citizens with Medicare and/or Medicare/Medicaid coverage and low-income people covered by Medicaid programs or cheap, poor-quality health plans are not able to access the same technology as individuals with private insurance.

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Individual