Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate

This is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be compared during a composite fasting day as well as therapeutic success after 2 weeks of normal activity.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ulm, 89081, Germany

Who can participate

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

Inclusion criteria

Adult patients >= 18 years of age
Type 1 diabetes
Diabetic for >2 years, and treated with CSII for >= 3 months
HbA1c <=8.5%

Exclusion criteria

Excessive fibrosis or lipo-hypertrophy at injection or infusion sites
Unstable chronic disease other than type 1 diabetes
Severe hypoglycemic event within last week prior to study start
Severe diabetic ketoacidosis within last month prior to study start

Treatment and study plan

Accu-Chek Spirit Insulin Pump

Device

One basal rate

Primary outcomes

Pilot trial to establish endpoints such as "time within target range of a composite fasting day"

Time frame: Study duration

Secondary outcomes

AUC, MAGE, HbA1c, body weight change

Time frame: Study duration

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Dec 7, 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.

Published trials that share one or more normalized conditions with this study.

Completed