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OpenTrials
Completed

NCT Number: NCT00468754

A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine

This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.

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Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bergamo, Italy

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetic patients, 18-60 years of age
  • Diabetic for >2 years
  • Treated with CSII for >=6 months
  • HbA1c <8.5%

Exclusion criteria

  • Treatment with daily insulin injections
  • Inability to handle pump therapy
  • Untreated retinopathy

Treatment and study plan

Insulin pumps

Device

Primary outcomes

  1. Variability of blood glucose characterised by the standard deviation of the mean blood glucose

    Time frame: Length of study

Secondary outcomes

  1. HbA1c

    Time frame: Length of study

  2. Mean BG during the last month of the respective treatment period

    Time frame: Length of study

  3. Frequency of severe hypoglycemia

    Time frame: Length of study

  4. Daily insulin requirement

    Time frame: Length of study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
May 3, 2007
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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