Medicare's criteria states: “…a fasting C-peptide level that is less than or equal to 110 percent of the lower limit of normal of the laboratory’s measurement method.” So, if the C-Peptide range for the specific lab I’ll be using is “0.80 to 3.85 ng/mL” does that mean that my C-Peptide would have to be less than or equal to.088 ng/mL?
Full Answer
When is a C-peptide indicated in the treatment of diabetes mellitus (DM)?
Recent guidelines developed by the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) dictate that a C-peptide should be used when there is doubt about what type of diabetes a patient is living with.
What is a normal C-peptide level?
In general, normal results for C-peptide in the bloodstream are between 0.5 and 2.0 nanograms per milliliter (ng/mL). However, results for the C-peptide test may vary based on the lab. Your doctor will be able to provide you with more information about the results and what they mean.
Is C-peptide good for low blood sugar?
Low blood sugar is common in diabetes, especially in people with type 1 diabetes taking insulin. It’s extremely rare for non-diabetics to experience low blood sugar [ 24 ]. In type 1 diabetes, C-peptide is beneficial because it signals some insulin-producing pancreas cells still exist.
Are C-peptide levels associated with mortality and morbidity in people without diabetes?
In almost 6k people without diabetes, higher C-peptide levels were associated with 80% higher all-cause mortality and more than 3 times higher heart disease mortality [ 69 ]!
What is the C peptide requirement for fasting?
Adjust Fasting C-peptide requirement such that the value must be less than or equal to , the lower limit of normal of the lab's measurement method, 10%.
What is the C peptide?
C-peptide is a polypeptide of 31 amino acids that acts as a structural connection within the proinsulin molecule. (Illustration reprinted with permission from Diagnostic Products Corporation www.dpcweb.com) It is released as a by-product when proinsulin, the precursor to insulin, is enzymatically cleaved to release insulin into the circulation. Insulin reserve, or the persistence of the ability to secrete insulin, is not an expected finding in Type I diabetes and low to undetectable levels of c-peptide should characterize the entity. Type II diabetics who require insulin should have a higher C-peptide level than Type I since Type II diabetes is frequently associated with insulin resistance as well as some insulin deficiency.
Why not remove C peptides?
It would be premature to remove the C-peptide requirement for several reasons: (1) For those Type I diabetics with higher C peptide levels above a lab's reference range, they most likely have residual beta-cell function. The extent to which aggressive insulin therapy alters the natural history of residual insulin secretion in Type I diabetes has not been firmly established, and it would be premature to allow an intensive insulin regimen without further study; (2) Since the physiology of the diabetes varies between Type I and Type II, we did not believe that one could extrapolate conclusions from data on patients with Type I diabetes to patients with Type II diabetes. It is still unclear as to the precise role of an intensive insulin regimen for all insulin-requiring Type II diabetics. C-peptide levels provide the necessary reliability and validity. Although imprecise, they are still useful. We are willing to revisit this issue as more information becomes available, either on the role of an intensive insulin regimen for Type II diabetes, or more information on the variability of C-peptide measurements.
What is the maximum peptide level for insulin pumps?
Broaden the limits of eligibility for coverage of insulin pumps and supplies to include patients with C-peptide levels up to 1.0 ng/mL
How long do you have to be on insulin for Medicare?
Patients who have been on an insulin pump for at least six months at the time of Medicare eligibility should also be exempt from the coverage requirement.
What is the RIA method for C-peptide?
In the RIA method, C-peptide is measured using goat anti-C-peptide. The antibody also recognizes proinsulin but has no crossreactivity with insulin. The analytic sensitivity of the test is 0.125 ng/ml and an overnight fast is required. The normal reference range for normal adults is 0.5 - 2 ng/mL. 6
Where is the C peptide catabolism site?
The kidney is the major site for C-peptide catabolism and excretion. In theory, those patients with renal dysfunction should have elevated C-peptide levels, since decreased urinary excretion would lead to elevated plasma levels. It is unclear, however, how much higher these levels should be. Researchers have come to different conclusions regarding the utility of assessing c-peptide levels in patients with renal dysfunction.
What is the function of a C-peptide test?
Another function of the c-peptide test is to rule out diabetes as the cause of hypoglycemia.
What is the minimum normal glucose for a lab?
Glucose must be 225 or more, c-peptide 110% or less of the minimum normal at your lab, simultaneous.
Can you pump with type 1?
I have even seen people with type 1 for many years be denied pumping based on the C-peptide test by Medicare. The test is basically biased mostly against people with type 2 but it can also be biased against those with type 1 as well. My whole thing is if you are already pumping when you start Medicare then one should be able to continue pumping, but I have read of people actually having to stop pumping because Medicare refuses to cover the supplies, etc.
Is 180 a good number for a blood test?
I read that 180 was a good number for the test. Personally, whatever it takes to get your body needing to create its own insulin should be good enough. Before my test I drank a bunch of cream in my coffee, dairy products always spike my BG, plus no insulin the day before or the morning
What is a C peptide test?
The C-peptide test is used to monitor insulin production in the body. The test can give doctors a lot of information about what’s happening in your body. distinguish between type 1 and type 2 diabetes, if the doctor isn’t sure which type of diabetes is present.
How many nanograms of C peptide are in the blood?
In general, normal results for C-peptide in the bloodstream are between 0.5 and 2.0 nanograms per milliliter (ng/mL).
What are the side effects of C-peptide test?
The C-peptide test may cause some discomfort when the blood sample is drawn. Common side effects include temporary pain or throbbing at the needle site.
How long do you have to fast for a C peptide test?
In some instances, you may be required to fast for up to 12 hours before the test. Fasting requires that you not eat or drink anything but water before the test. You may also need to stop taking certain medications.
What does it mean when your C peptide is high?
If your C-peptide level is higher than normal, it can mean that your body produces too much insulin.
Where is the C peptide test taken?
The blood is drawn from a vein, typically in the arm or on the back of the hand. The procedure can cause minor discomfort, but the discomfort is temporary. The blood will be collected in a tube and sent to a lab for analysis.
Which type of diabetes has lower C-peptides?
both type 1 and type 2 diabetes (people with type 1 diabetes typically have even lower C-peptide levels than people with type 2 diabetes)
What is C-Peptide?
You probably already know about insulin, the hormone that decreases blood sugar levels. Insulin’s main function is to transport sugar ( glucose) from the blood into your cells and tissues. There, glucose can be converted into energy or stored for future use.
Why is C-peptide important for diabetics?
In type 1 diabetes, C-peptide is beneficial because it signals some insulin-producing pancreas cells still exist. Type 1 diabetics who have detectable C-peptide levels require less insulin and are not as prone to chronic complications, such as heart disease and kidney, nerve, and eye damage [ 25, 26, 27 ].
What does it mean when your C peptide is low?
If your C-peptide levels are low, that may mean your pancreas isn’t working properly and the body is not making enough insulin [ 2 ]. Your doctor will interpret this test, taking into account your medical history, signs and symptoms, and other test results.
Why is C peptide high?
High C-peptide levels can be caused by: Carbs and the resulting increase in blood sugar. After a meal, higher glucose levels in the blood signal the pancreas to release insulin and C-peptide [ 36, 37 ]. Insulin resistance.
What causes low C peptides?
Low C-peptide can be caused by: Type 1 diabetes, an autoimmune condition in which insulin-producing cells of the pancreas get destroyed [ 2, 12 ]. LADA, latent autoimmune diabetes in adults, also known as type 1.5 diabetes [ 13, 14, 15 ]. Type 2 diabetes, insulin dependent.
What test can you use to determine if you need to take insulin?
Monitor diabetes. Doctors can use a C-peptide test to decide whether you need to take insulin or to adjust the dosage if you are already taking it.
Is C peptide an inactive peptide?
C-peptide was initially considered inactive – a mere byproduct of insulin production. But studies revealed that this peptide actually has both anti-inflammatory and pro-inflammatory effects in the body, depending on its levels [ 3, 4, 5 ].
When to use C peptide?
Recent guidelines developed by the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) dictate that a C-peptide should be used when there is doubt about what type of diabetes a patient is living with.
Why is it important to know your C peptide level?
Therefore, knowing your C-peptide level is crucial in understanding what type of diabetes you have.
What does a C peptide test tell you?
The C-peptide test will tell you what type of diabetes you are actually living with (4), and help you differentiate between an autoimmune version of diabetes (with extremely low insulin production) and lifestyle-related diabetes (with medium to high insulin production).
What is the significance of the discovery of C-peptides?
At the time, this discovery was a landmark insight into the physiology of diabetes, because they discovered that insulin and C-peptide are made in equal amounts, and that C-peptide remained in the blood for substantially longer periods of time than insulin.
Why is the C-peptide test important?
We consider the C-peptide test to be one of the most valuable diagnostic tests available today, because together with an antibody test, they can definitively guide your method of diabetes treatment or reversal.
What are the criteria for a diagnosis of a diabetic?
These three factors must be present in order for a patient to be diagnosed with LADA: Adult age of onset (greater than 30 years) The presence of at least 1 islet cell autoantibody.
Is C-peptide lower in type 1 diabetes?
If you are living with an autoimmune version of diabetes (either type 1 or type 1.5 diabetes), then your C-peptide value will most likely be significantly lower than if you are living with prediabetes or type 2 diabetes.
How to test for C peptides?
The C-peptide test typically uses a sample of your blood. To take a blood test, someone in your doctor’s office or a lab places a needle into a vein, usually in your forearm. You may feel a slight prick. The blood will collect into a vial or syringe.
What does low C peptide mean?
A low C-peptide level may mean that: 1 You have type 1 or type 2 diabetes with a tired pancreas--or more advanced disease 2 You are on insulin shots and it is suppressing the release of insulin from your pancreas 3 You have low blood sugar so your pancreas stops releasing insulin or you are taking insulin so your pancreas isn't releasing any 4 Treatment has shrunk your insulinoma
II. Background
- On April 1, 2004, CMS began a national coverage determination (NCD) for reconsideration of C-peptide levels as a criterion for use of insulin pumps in diabetic patients. Diabetes is a disease in which insulin is absent or not functionally available in sufficient quantities to metabolic pathway…
III. History of Medicare Coverage
- CMS’s Center for Medicare Management (CMM) has determined that the subcutaneous insulin infusion pump falls within the benefit category set forth for “Durable Medical Equipment” in Section 1861(n) of the Social Security Act. On August 26, 1999, HCFA (now CMS) issued the first decision memorandum (CAG-00041N) for “Continuous Subcutaneous Insulin Infusion Pumps” th…
v. FDA Status
- Medtronic MiniMed’s 508 insulin infusion pump received 510(k) marketing approval as a class II device on August 18, 2000. Medtronic MiniMed’s Paradigm insulin infusion pump received 510(k) marketing approval as a class II device on June 8, 1999. These pumps are indicated for use at set and variable rates for the management of diabetes mellitus in persons requiring insulin. In an Ap…
VI. General Methodological Principles
- When making national coverage determinations, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. The overall objective for critical appraisa…
VII. Evidence
- A. Introduction This summary represents the body of evidence describing C-peptide levels and other laboratory measures as critical selection criteria for continued rational study and use of CSII pump therapy in diabetic Medicare patients. The health outcomes of interest to CMS include changes in the incidence of complications such as neuropathy, retinopathy, nephropathy or infe…
VIII. CMS Analysis
- National coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act § 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwi…
IX. Conclusions
- CMS, therefore, updates its Medicare coverage criteria to better identify those diabetic patients who would most benefit from CSII. We hope this decision memorandum encourages further research into diagnostic criteria for appropriate selection of patients requiring intensive insulin management including CSII, as well as into the comparative safety and effectiveness of various …
Background
- On September 24, 1999 the Health Care Financing Administration (HCFA) announced coverage for the use of continuous subcutaneous insulin infusion (CSII) pumps for Medicare recipients with Type I diabetes. 1The decision requires that physicians document Type I diabetes with a C-peptide level of less than 0.5 ng/mL when requesting coverage for a conti...
Reference Values For Normal C-Peptide Levels
- Unlike many other laboratory tests, there can be several reference ranges for C-peptide levels, especially depending upon type of laboratory assay used, age of patient, and whether or not a patient has fasted prior to the test. There are two laboratories processes routinely used to quantify C-peptide.5These include: 1. radioimmunoassay (RIA) method and 2. immunochemilum…
Summary of Evidence
- Scientific Studies The medical literature was searched using OVID and PubMed. Search terms included "C-peptide", "Type 1 Diabetes", "Type 2 Diabetes", "NIDDM" and "IDDM." A total of nine studies were reviewed. Note that studies vary in terms of units used to express C-peptide level. In general, ng/mL x 0.331 = nmol/L. Welborn et al. (1981) designed a study to determine diabetes t…
Position Statements
- Neither the American College of Endocrinology (ACE), nor the American Diabetes Association (ADA) has an official position statement on the use of C-peptide as a criterion for distinguishing between Type I and Type II diabetics, or as a requirement for the use of an insulin pump. However, both societies have written to the agency on this topic. In a March 26, 2001 letter to HCFA, Hele…
HCFA Analysis
- In determining the usefulness and appropriateness of C-peptide as a criterion for the continuous subcutaneous insulin infusion pump, HCFA addressed the following analytic questions: 1. What are the reference values for normal C-peptide levels? How sensitive are the various measurement tests? 2. What is the appropriate value for making the distinction between Type I and Type II bas…
Conclusion
- The use of C-peptide appears to be a rational means of discriminating residual beta-cell function. There is consensus that Type I diabetes leads to beta-cell destruction and absolute insulin deficiency, with a resultant low C-peptide level. Such a patient population could benefit from an intensive insulin regimen, including a subcutaneous insulin infusion pump, and the evidence curr…
Decision
- Revise Coverage Issues Manual 60-14, so that: 1. Adjust Fasting C-peptide requirement such that the value must be less than or equal to, the lower limit of normal of the lab's measurement method, 10%. 2. Remove the Type I requirement, to include Type II diabetics as long as they meet all other requirements, including fasting C-peptide requirement, as noted above. COVERAGE ISS…