Clinical trial NCT03400501: Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin
Official title: Reducing the Risk of Metabolic Decompensation in Adolescents With Poorly Controlled Type 1 Diabetes by Supervised School Administration of Insulin Degludec
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 32
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study to examine and compare the efficacy of supervised injections of long acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes (T1D) from development of ketones.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lower beta hydroxybutyrate levels
timeFrame: 4 months
Secondary outcomes:
measure: Control of HbA1c levels
timeFrame: 4 months
measure: Measure of beta hydroxybutyrate levels between the 2 groups.
timeFrame: 4 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: MED School of Medicine
name: William Tamborlane, PhD
role: PRINCIPAL_INVESTIGATOR
References: