Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin

This study will compare the proportion of days with fasting β-hydroxybutyrate levels ≥0.6
mmol/L at the start of the school week following weekend/holiday breaks in subjects who have
been randomized to receive daily injections of I-deg or I-glar. Hypothesis: β-hydroxybutyrate
levels will be lower in the morning of the first day of the school week in subjects receiving
I-deg than in subjects receiving I-glar, since the long half-life of I-deg will compensate
for missed insulin doses over the weekend/holidays. To remove variability due to potential
non-compliance during the school week, this study will utilize our routine clinical practice
of supervised insulin administration and monitoring of blood glucose and ketones during the
school day.

Inclusion Criteria:

- Clinical diagnosis of T1D, diagnosed at least 12 months prior to enrollment

- HbA1c ≥8.5%9 and <14% on enrollment

- Taking no medications known to affect blood glucose levels other than insulin.

- Ability to provide participant written informed consent if age 18 years, or parental
written informed consent and participant assent if participant is < age 18 before any
trial-related activities

- Current regimen includes insulin detemir or I-glar, as long acting insulin

- Willingness to use either I-glar or I-deg pens as basal insulin, and have school
personnel supervise administration

- Willingness to have school personnel supervise fasting blood β-hydroxybutyrate levels
first thing in the morning at the beginning and end of each school week

- Willingness to have school personnel supervise fasting blood glucose checks daily in
the morning on school days, and eat breakfast after the fasting check

Exclusion Criteria:

- Female participants who are pregnant, breast-feeding or planning on becoming pregnant

- Participant (and parent if age <18) unable to read, write, and speak English.

- Adolescents who are home schooled or no longer attending secondary school

- Participant's school is unable to provide personnel to supervise injections of
long-acting insulin or measurement blood glucose and β-hydroxybutyrate levels

- Known or suspected allergy to trial medication(s), excipients, or related products.

- Contraindications to study medications, including hypersensitivity to I-deg or one of
its excipients, hypersensitivity to I-glar or one of its excipients, and
administration of either during episodes of hypoglycaemia