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Insulin pump therapy and insulin injections are generally considered safe insulin delivery methods.
However, there are some differences in their safety profiles that are imperative to consider.

One of the main safety concerns associated with insulin pump therapy is diabetic ketoacidosis (DKA)
(Alshami et al., 2021). DKA is a serious complication of diabetes that occurs when the body produces
high levels of ketones, which can lead to coma or even death if left untreated (Health Navigator, 2022).
Several studies have reported a higher risk of DKA in patients on insulin pump therapy than those on the
insulin injection method, especially in patients with T1D (Alshami et al., 2021; Flores et al., 2020; Karges
et al., 2017; Wersall et al., 2022). The increased risk of DKA with insulin pump therapy is thought to be
due to several factors, including infusion set problems, interruption of insulin delivery, and insulin
degradation in the pump (Wersall et al., 2022).

On the other hand, the insulin injection method is associated with a lower risk of DKA but a higher risk of
hypoglycemia than insulin pump therapy (Pala et al., 2019). Hypoglycemia is a common complication of
insulin therapy that occurs when blood glucose levels fall too low, which can lead to seizures, coma, or
even death if left untreated (Cryer 2007). The risk of hypoglycemia is higher with the insulin injection
method because it is more difficult to achieve precise dosing, and there may be delays in insulin
absorption due to factors such as injection site variability, physical activity, and food intake (Gradel et al.,
2022).

Recruited subjects, together with their families if minor, will have to attend an education session, to
review about insulin types, insulin adjustment, and carbohydrate counting. Families that had not
previously used carbohydrate/insulin ratios or corrective doses for management should use these
techniques after the session. Then, subjects will be randomly assigned to begin pump therapy (IG) or to
continue insulin injections (CG). Randomization will be done by having the participants draw sealed
envelopes. Families randomize to IG will not begin on pump therapy immediately but will be asked to
return later for a month of pump education.

From this point forward, all families will be asked to monitor blood glucose levels prior to each meal and
at bedtime, using Dexcom G7. Blood glucose measures will be sent in at least weekly, and insulin
adjustments will be made by a trained healthcare worker. The blood sugar target range is 100 to 220 mg/
dL during the day, with bedtime blood sugars >150 mg/dL. After every participant and their families in
the IG are ready to start the pump therapy, all subjects will be taken a blood sample for measurement of
hemoglobin (HbA1c) for the baseline of their glucose level. Those randomized to IG will be provided a
Tandem t:slim X2 pump and a MiniMed 770G insulin infusion pump. Families will be asked to change the
insulin infusion set every 3 days to minimize subcutaneous reactions. During the study period, subjects
or their family members will be given 24-hour access by telephone and pager to the investigator to
directly answer their concerns. Then, patients will return to clinic for follow-up 1, 3, and 6 months after
the first visit (baseline). At each visit, families will be asked to bring their log books and glucose meters,
and to give a blood sample for measurement of hemoglobin HbA1c. Meters and pumps will be
downloaded for data collection. Outcome measures will include HbA1c, and number of severe
hypoglycemic events (blood glucose level ≤ 70 mg/dL), and number of blood sugars below the target
range.