. 2019 Mar 30;21(4):159–169. doi: 10.1089/dia.2019.0011

Table 1.

Glycemic Treatment Guidelines

Measurement	Conditions	Actions	Follow-up
A. Any SMBG^a	Seizure Loss of consciousness Unable to eat or drink	• Stop the system • Notify MD as soon as possible • Disconnect the study insulin pump • Give 1 mg of glucagon^b following instructions in the glucagon emergency kit o Glucagon may be repeated in 20 min if needed o Avoid orange juice and milk ingestion after glucagon due to possible nausea and vomiting • Call 9-1-1 • Test BG and when able to eat or drink, give 16–32 g of fast acting carbs (preferably glucose tabs or gel/liquid) with NO insulin. Repeat until BG >80 mg/dL • When BG >80 mg/dL resume insulin pump therapy with HOME insulin pump (NOT STUDY PUMP) • The study will be stopped	Treat first^c Repeat SMBG when able and every 15 min until BG >100 mg/dL
B. Two consecutive SMBGs <50^a	Conscious Able to eat and drink	• Notify MD as soon as possible • Consecutive is >30 and <60 min apart • Treat with 8 glucose tablets (or ∼32 g of fast-acting carbs) and check BG ∼every 15 min • Treatment screen • If there are 2 consecutive (>30 and <60 min) SMBG <50, the subject will stop participation in the study o Disconnect the study insulin pump o Notify MD as soon as possible o When BG ≥100 mg/dL resume insulin pump therapy with HOME insulin pump (NOT STUDY PUMP)	Check SMBG every 15 min until BG ≥100 mg/dL
C. SMBG 50–69^d	Conscious Able to eat and drink	• Notify MD as soon as possible • Treat with 4 glucose tablets (or ∼16 g of fast-acting carbs) and check BG ∼every 15 min • Repeat as needed	Check SMBG every 15 min until BG ≥100 mg/dL
D. Pre-exercise SMBG >100^e	Asymptomatic and well	• Able to exercise	Follow CGM-based guidelines
E. Pre-exercise SMBG ≤100^e,f	Before exercise	• Treat with fast acting carbs until BG >100 mg/dL before exercising	Follow CGM-based guidelines after SMBG >100 mg/dL
F. SMBG >300^d	Feeling well	• Check infusion set and check that pump is working properly • Consider correction bolus via pen or syringe • Continue with study	Check BG every 1 h until BG <250 mg/dL

G. CGM <60^d	Conscious Able to eat and drink	• Performed SMBG, if lower than 69 proceed with B or C	Check SMBG every 15 min until BG ≥100 mg/dL
H. CGM 60–299^g	Feeling well	• Follow devices user guide and alerts (e.g., take CHO for hypoglycemia threshold or predictive alerts)	Consider checking SMBG if arrow is pointing straight down or straight up
I. CGM >300 for more than 1 h	Feeling well	• Performed SMBG, If SMBG >300 mg/dL follow F	Check BG every 1 h until BG <250 mg/dL
J. CGM >300 for more than 2 h	Feeling well	• Check ketones, if ketones >0.6 follow K or L • Performed SMBG, If SMBG >300 mg/dL follow F	Check BG every 1 h until BG <250 mg/dL
Ketone measurements: test for ketones any time indicated above. Refer to table below if ketones ≥0.6
K. Ketones 0.6–3.0^a	Any	• Notify MD as soon as possible • Consider taking correction dose of insulin by syringe or pen • Change insulin in reservoir and tubing and change pump site • Drink sugar-free beverages • Once BG is 100–250 mg/dL, restart pump treatment in appropriate mode. Record the amount of insulin that was given when prompted	Check SMBG and ketones every hour until BG <250 mg/dL and ketones ≤0.6
L. Ketones >3.0^a	Any	• The participant will stop the study • Notify MD as soon as possible • Disconnect the STUDY insulin pump and start HOME insulin pump once instructed by MD • Take correction dose of insulin by syringe or pen • Drink sugar-free beverages	Check SMBG and ketones every hour until BG <250 mg/dL and ketones ≤0.6 or until transferred to an appropriate treatment environment
Symptoms requiring action regardless of blood sugar or ketone levels
Any^a	Abdominal pain Vomiting illness Unable to eat or drink Fever ≥101.5°F Clinical need for Tylenol/acetaminophen Significant illness Use of epinephrine or glucocorticoid, for example to treat a severe allergic reaction	• Notify MD as soon as possible • Participant STOP study • Disconnect the STUDY insulin pump and start HOME insulin pump • Subcutaneous insulin correction and insulin infusion set change^h	Check SMBG and ketones every hour until symptoms resolve or until transferred to an appropriate treatment environment

Subjects will be trained and instructed to respond to CGM and/or artificial pancreas alarms and treat hypoglycemia/hyperglycemia readings accordingly.

Self-monitoring blood glucose measurements schedule:

• Before exercise

• CGM hypoglycemia <60 mg/dL

• CGM hyperglycemia >300 mg/dL

• Before CGM calibration (prebreakfast and predinner could be used to calibration)

^{^a}

The subject may stop participation in the study.

^{^b}

Glucagon 1 mg can be given subcutaneously or intramuscularly. Repeat meter glucose level in 15 min.

^{^c}

Oral glucose treatment consists of ∼16 g of simple carbohydrate, for example, glucotabs or juice followed by a repeat meter glucose measurement after 15 min.

^{^d}

Treatment may be needed.

^{^e}

Correspond to pre-exercise.

^{^f}

SMBG will be performed within 30 min of exercise; if <100 mg/dL subject will be treated until >100 mg/dL before beginning exercise.

^{^g}

Continue the study.

^{^h}

Additional correction boluses may be administered no more frequently than every 4 h as needed to achieve meter glucose between 80 and 250 mg/dL and β-ketone measurement ≤0.6 mmol/L.

CGM, continuous glucose monitor; MD, medical doctor; SMBG, self-management blood glucose.