Specimen Collection Form

Privacy Act Statement
The information you are being asked to provide is authorized to
be collected under Section 301 of The Public Health Service Act
(42 USC 241). Providing this information is voluntary. CDC will
use this information in its study, SEARCH for Diabetes in Youth,
(affix label here)
in order to: (1) Assess the incidence and prevalence of diabetes
among youth in the U.S. by diabetes type, and by demographics
including age, sex, and race/ethnicity; and (2) Assess temporal
Patient ID
trends in diabetes incidence in major US racial/ethnic groups,
Number
Site
Sub-site
including African Americans, Hispanics, American Indian Tribes,
Asian Americans, Pacific Islanders, by age, sex, and diabetes
type. This information will be shared with third party clinical
entities with whom CDC has entered into an Agreement to assist
with carrying out this Study.
SEARCH 4 Specimen Collection Form

Form Approved
OMB No. 0920-0904
Exp. Date 08/31/2017

Sequential ID

Before drawing blood or collecting urine specimens:
1. Have you had DKA in the last 4 weeks that resulted in hospitalization or had to be treated by IV fluids?
1 No
st
2 Yes (if YES, then do NOT draw blood AND do not collect/send 1 morning void specimen and

do not complete this form)

2. Have you had a severe low blood sugar in the past 24 hours that required you to get help (glucagon injection,
called 911, went to an emergency room or urgent care center)?
1 No
st
2 Yes (if YES, then do not collect/send 1 morning void specimen and re-schedule urine)
3. Have you had a fever greater than 100 degrees in the past 24 hours?
1 No
st
2 Yes (if YES, then do NOT collect/send 1 morning void specimen and re-schedule urine)
4. In the past month, have you been told by a doctor that you have a urinary tract infection?
1 No
2 Yes (if YES, are you currently taking an antibiotic for your infection?)
1
2

No (if NO, collect urine specimens)
Yes (if YES, then do NOT collect/send 1st morning void specimen and re-schedule

urine)

The next questions are for females only:
5. Are you currently pregnant?
1 No
st
2 Yes (if YES, do NOT draw blood AND do NOT collect/send 1 morning void specimen and do

not complete this form)
st
3 Unsure (if UNSURE, draw blood AND collect/send 1 morning void specimen) (Script for
Coordinator: “If you find out later that you were pregnant today, please let us know.”)

6. Were you menstruating when you did your 1st morning void urine collection?
1
2

No
Yes (if YES, do NOT send 1st morning void urine sample and re-schedule urine)

Public reporting burden of this collection of information is estimated to average 20 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining data needed, and completing and reviewing the
collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden to CDC Reports Clearance Officer; 1600 Clifton
Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0904).
SEARCH 4 Registry Specimen Collection Form_030416Page 1 of 5

7. Have you taken any insulin in the last 4 hours? (This does NOT include basal insulin per insulin pump.)
1 Yes (if YES, ask which insulins were taken; mark by the appropriate list of insulins below)
2 No (if NO, go to question 9)
Degludec (Tresiba)
1

Detemir (Levemir)
Glargine (Lantus)

Acceptable

Humulin N
Novolin N
NPH
Humulin R
2

Humulin 50/50

Time:

Humulin 70/30

AM
Hour

Minute

PM

Novolin R
Novolin 70/30

NOT acceptable if taken within 4 hours
prior to fasting blood sample – Proceed
with blood draw and try to re-schedule a
fasting re-draw visit.

Regular
Apidra
Glulisine
Humalog

AM
Time:

Hour

Minute

PM

Humalog mix 50/50
3

Humalog mix 75/25
Novolog

NOT acceptable if taken within 2 hours
prior to fasting blood sample – Proceed
with blood draw and try to re-schedule a
fasting re-draw visit.

Novolog mix 70/30
(by injection or bolus
per pump)

8. Have you taken any other diabetes medications in the last 8 hours?
1

Yes (if YES, ask which medications were taken and mark by the appropriate list of

2

No

medications below; then answer question 9a on next page)

Other diabetes medications:

1

Acarbose (Precose)
Actos
Avandamet
Avandia
Canaglifozin (Invokana)
Dapaglifozin (Forxiga)
Empagliflozin (Jardiance)
Glucophage
Glyset
Metformin (metformin extended

Acceptable medications

release [metformin ER], [Glucophage,
Riomet, Fortamet, Fortamet ER,
Glumetza])
Miglitol
Orlistat (Xenical, Alli)
Precose
Pioglitazone (Actos)
Rosiglitazone

SEARCH 4 Registry Specimen Collection Form_030416Page 2 of 5

Albiglutide (Tanzeum)
Amaryl
Byetta
Chlorpropamide
Delaglutide (Trulicity)
DiaBeta
Diabinese
Empagliflozin (Jardiance)
Exenatide (Byetta, Bydureon)
Glimepiride (Amaryl)
Glipizide, Glipizide ER (Glucotrol,

Time:
Hour

 AM
 PM

NOT acceptable if taken within 8
hours prior to fasting blood sample

Glucotrol XL)

2

Glucotrol
Glucovance
Glyburide (Diabeta, Micronase)
Glynase
Januvia
Liraglutide (Victoza)
Micronase
Metformin + Sitagliptin (Janumet)
Metformin + Saxagliptin (Kombiglyze

Minute

Proceed with blood draw and try to
re-schedule a fasting re-draw visit.

XR)

Metformin + Linagliptin (Jentadueto)
Nateglinide
Prandin
Pramlintide (Symlin)
Repaglinide
Saxagliptin (Onglyza)
Sitagliptin (Januvia)
Starlix
Symlin
Tolazamide
Tolbutamide
Victoza

1

Other diabetes medications: (specify)

IF UNACCEPTABLE INSULIN OR ORAL MEDICATION TAKEN, PROCEED WITH BLOOD DRAW AND TRY TO
SCHEDULE A FASTING RE-DRAW VISIT.
8a.

If a re-draw visit is necessary, has Participant agreed? 1

Yes

9. Have you had anything to eat or drink in the last 8 hours?
1

Yes

9a. If YES, ask the Participant what they

had to eat or drink. Describe what they
had to eat or drink.

9b. If Participant consumed non-allowable

food or drink, record most recent time

SEARCH 4 Registry Specimen Collection Form_030416Page 3 of 5

Time:

AM PM
Hour

Minute

2

No

IF FASTING LESS THAN 8 HOURS, PROCEED WITH BLOOD DRAW AND TRY TO SCHEDULE A FASTING RE-DRAW VISIT.
9c.
2

If a re-draw visit is necessary, has Participant agreed? 1 Yes

2

No

No

10. Glucose meter reading:

(May use drop from blood collected with venipuncture samples)

If glucose is > 300 mg/dl, perform urinary ketone check and record.
10a. Urine ketones: 1 Negative

2

3

Trace/small

Moderate

4

11. Were any of the following symptoms observed or reported by the Participant?

5

Large
1

Yes

(If YES, check all that apply):
1

Abdominal pain

1

Diaphoresis (excessive sweating)

1

Lightheadedness

1

Nausea and or vomiting

1

Seizure

1

Tremors or trembling

1

Loss of consciousness due to low blood glucose

1

Loss of consciousness due to phlebotomy (fainting)

1

Blood glucose is < 45 mg./dl.

1

Blood glucose is > 300 mg./dl. with moderate or large ketones

1

Blood glucose is > 500 mg./dl. with or without ketones

1

Other (specify):

Unable to obtain

2No

12. Comments?
1

2

Yes (if YES, describe) :

No comments

NOTE: Complete SEARCH Unanticipated Occurrence/Condition Reporting Form if
any of the below presents:



seizure
loss of consciousness due to low blood glucose

13. Specimen obtained
by:

(code)

14. Date specimen

obtained:
Month

Day

Hour

Minute

15. Time specimen

collected:

Year

 AM /  PM (check one)

SEARCH 4 Registry Specimen Collection Form_030416Page 4 of 5

Please instruct the Participant to take medication/insulin and provide breakfast to the Participant.

FOR STUDY USE ONLY
Date Completed

Completed by
Month

Day

Year

Date Reviewed

Reviewer Code
Month

Day

Year

Date Entered
Month

Day

Year

SEARCH 4 Registry Specimen Collection Form_030416Page 5 of 5

Data Entry
Code