A pilot randomized controlled study to evaluate safety and efficacy of Conversion from Insulin Glargine U100 to Glargine U300 in Youth with Type 1 Diabetes

A pilot randomized controlled study to evaluate safety and efficacy of Conversion from Insulin Glargine U100 to Glargine U300 in Youth with Type 1 Diabetes, comparing standard conversion regimen with an individualized dose titration regimen using continuous glucose monitoring.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210901004

Enrollment

Registered

2021-09-01

Start date

2021-09-28

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus Type 1 Diabetes Mellitus Glargine U100 Glargine U300

Interventions

Participants will be switched glargine U100 to glargine U300 with the individualized dose titration regimen: glargine U100 will be switched to glargine U300 with 1:1 ratio and in the first day of tran

Active Comparator Drug,Placebo Comparator Drug

Switching glargine U100 to glargine U300 with the individualized dose titration regimen,Switching glargine U100 to glargine U300 with 1:1 ratio as FDA recommendation

Eligibility

Sex/Gender

All

Age

12 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. Patients with a firmed diagnosis of type 1 DM 2. Duration of DM > 1 year 3. Previously treated with basal-bolus regimen and using glargine U100 dose as the basal insulin 4. A1C equal or less than 13% 5. Follow-up visit at King Chulalongkorn Memorial Hospital 6.Have an intention or clinical benefit to switch to glargine U300

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Previously treated with human insulin (RI and NPH) or using human insulin within 1 week 3.Previously treated with glucose lowering medications other than insulin 4. Currently treated with systemic glucocorticoid

Design outcomes

Primary

Measure	Time frame
Percentage of Time in Range (%TIR) by CGM At 1 week after the end of the intervention Continuous Glucose Monitoring devices	—

Secondary

Measure	Time frame
Fasting blood glucose 1 week after the end of the intervention Glucometer,Daily Dose of Glargine 1 week after the end of the intervention Insulin log diary,Daily Dose of rapid insulin analog, Total dose for correction of hyperglycemia 1 week after the end of the intervention Insulin log diary,Percentage of time above range by CGM 1 week after the end of the intervention Continuous Glucose Monitoring device,Percentage of time below range by CGM 1 week after the end of the intervention Continuous Glucose Monitoring device,Average daily blood glucose levels 1 week after the end of the intervention Glucometer,Serious adverse events 1 week after the end of the intervention Glucometer and clinical	—

Measure

Time frame

Fasting blood glucose 1 week after the end of the intervention Glucometer,Daily Dose of Glargine 1 week after the end of the intervention Insulin log diary,Daily Dose of rapid insulin analog, Total dose for correction of hyperglycemia 1 week after the end of the intervention Insulin log diary,Percentage of time above range by CGM 1 week after the end of the intervention Continuous Glucose Monitoring device,Percentage of time below range by CGM 1 week after the end of the intervention Continuous Glucose Monitoring device,Average daily blood glucose levels 1 week after the end of the intervention Glucometer,Serious adverse events 1 week after the end of the intervention Glucometer and clinical

—

Countries

Thailand

Contacts

Public ContactTaninee Sahakitrungruang

Faculty of Medicine, Chulalongkorn University

ptaninee@hotmail.com66816468083

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026