Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT00146484

A Study of Two Versus Three Daily Injections in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
A Randomized Controlled Trial of Two Versus Three Daily Insulin Injections in Children and Adolescents With New Onset Type 1 Diabetes Mellitus

Clinical Trial Summary

The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. The purpose of this study is to determine whether a split evening injection regimen (insulin injections before breakfast, supper and bedtime) leads to better glucose control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.

Clinical Trial Description

The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. No published studies have examined the effectiveness of a split evening (three times daily) injection regimen in this group of patients. Indeed, because the first few years of diabetes management are the easiest (due to a “honeymoon” period characterised by residual insulin secretion), the potential for any benefit from more intensive management (i.e., three daily injections) may be small during this period. In addition, the intensity of the initial insulin regimen may be an important determinant of quality of life, family functioning, and subsequent compliance with diabetes regimens. A randomized controlled trial has been designed to test the hypothesis that a split evening injection regimen leads to better glycemic control and quality of life than twice daily insulin in children and adolescents with new onset diabetes. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00146484
Study type Interventional
Source Children's Hospital of Eastern Ontario
Contact
Status Completed
Phase Phase 2
Start date April 1996
Completion date January 2001
View Details
See also
  Status Clinical Trial Phase
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT03605329 - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Recruiting NCT06050642 - Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop. N/A
Completed NCT05107544 - Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes N/A
Active, not recruiting NCT04443153 - Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes N/A
Completed NCT04569994 - A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes Phase 1
Completed NCT04521634 - Glycaemic Variability in Acute Stroke
Completed NCT04089462 - Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study N/A
Completed NCT03143816 - Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study Phase 4
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A
Completed NCT04042207 - Diabeloop for Highly Unstable Type 1 Diabetes N/A
Not yet recruiting NCT06068205 - COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Recruiting NCT05909800 - Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes. Phase 2
Active, not recruiting NCT04974528 - Afrezza® INHALE-1 Study in Pediatrics Phase 3
Completed NCT04530292 - Home Intervention and Social Precariousness in Childhood Diabetes N/A
Completed NCT05428943 - OPT101 in Type 1 Diabetes Patients Phase 1
Recruiting NCT03988764 - Monogenic Diabetes Misdiagnosed as Type 1
Completed NCT05597605 - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects N/A