Clinical Trials Logo

Clinical Trial Summary

Background. Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.

Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00360815
Study type Interventional
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact
Status Completed
Phase N/A
Start date August 1983
Completion date April 1993

See also
  Status Clinical Trial Phase
Completed NCT04476472 - Omnipod Horizon™ Automated Glucose Control System Preschool Cohort N/A
Completed NCT03635437 - Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes Phase 1/Phase 2
Completed NCT04909580 - Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes N/A
Active, not recruiting NCT00679042 - Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol Phase 3
Completed NCT03293082 - Preschool CGM Use and Glucose Variability in Type 1 Diabetes N/A
Completed NCT04016662 - Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D) Phase 4
Completed NCT02527265 - Afrezza Safety and Pharmacokinetics Study in Pediatric Patients Phase 2
Completed NCT03738865 - G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes Phase 3
Completed NCT03240432 - Wireless Innovation for Seniors With Diabetes Mellitus N/A
Completed NCT03168867 - Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms) N/A
Completed NCT03674281 - The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System N/A
Completed NCT03669770 - Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
Recruiting NCT03682640 - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes Phase 2
Recruiting NCT04096794 - Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Completed NCT02882737 - The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus N/A
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Withdrawn NCT02518022 - How to be Safe With Alcoholic Drinks in Diabetes N/A
Completed NCT02596204 - Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring N/A
Completed NCT02562313 - A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog® Phase 1
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1