Status:
COMPLETED
Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin
Lead Sponsor:
Yale University
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
8-18 years
Phase:
EARLY_PHASE1
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 deve...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03400501
Start Date
October 1 2017
End Date
June 7 2021
Last Update
November 5 2021
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06511