N/A
N=1,939
Opportunistic Screening for Prediabetes and Early Diabetes in Primary Care
Type 2 Diabetes Mellitus · Prediabetic State
Bottom Line
View on ClinicalTrials.gov: NCT00787839 ↗Enrolled (actual)
1,939
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Ability of Different Screening Tests Which Can be Performed Opportunistically (During Outpatient Visits -- at Any Time of Day, Regardless of Meal Status) to Predict Findings With the Oral Glucose Tolerance Test (in the Morning, After an Overnight Fast) — .85; .82; .76; .72 area under ROC curve
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Glucose challenge test (Other); Glucose tolerance test (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ability of Different Screening Tests Which Can be Performed Opportunistically (During Outpatient Visits -- at Any Time of Day, Regardless of Meal Status) to Predict Findings With the Oral Glucose Tolerance Test (in the Morning, After an Overnight Fast) |
.85; .82; .76; .72; .67; .76 | — |
| SECONDARY Cost to Identify a Single Case of High-risk Dysglycemia or Previously Unrecognized Diabetes |
100; 93; 42; 37; 133; 125 | — |
Summary
People who might have prediabetes or unrecognized diabetes will be screened for these problems at an outpatient visit. For screening, they will take a sugary drink containing 50 grams of glucose, and have a blood sample one hour later. The blood sample will be tested for glucose and A1c (a measure of blood glucose over the previous two months). They will also fill out questionnaires that ask about their health history and how they would feel about exercising and trying to lose weight if they are found to have prediabetes or diabetes. At a subsequent visit, they will have an oral glucose tolerance test (OGTT) - a blood sample, then a sugary drink containing 75 grams of glucose, and a repeat blood sample 2 hours later. We will evaluate the costs of finding out if people have prediabetes or diabetes. For people who are found to have these problems, we will also evaluate how well their doctors treat these problems.
Eligibility Criteria
Inclusion Criteria
- veteran status,
- ambulatory outpatient at Atlanta VA Medical Center,
- visit to primary care clinic, AND
- meet criteria for screening (age >= 45 years or other risk factors [body mass index >=25 or hypertension or systolic blood pressure >=140 or HDL cholesterol 250 or first-degree relative with diabetes or minority race or minority ethnicity or history of diabetes during pregnancy or history of having a baby weighing >9 pounds or history of polycystic ovary syndrome])
Exclusion Criteria
- known to have diabetes, OR
- taking steroids OR pregnant, OR
- not well enough to have worked during the previous week (actual employment not necessary)
Data sourced from ClinicalTrials.gov (NCT00787839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.