We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Web-based Insulin Titration - An Efficacy Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01715090
First Posted: October 26, 2012
Last Update Posted: November 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  Purpose
The main objective of the study is to determine whether an intensive web-based titration system, called PANDIT (Patient Assisting Net-based Diabetes Insulin Titration), is effective in improving glycaemic control in patients with diabetes mellitus type 2 using a basal insulin, compared to standard care.

Condition Intervention
Diabetes Mellitus, Type 2 Device: Web-based insulin titration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Web-based Insulin Titration: Improving Diabetes Care in the Netherlands. An Efficacy Study.

Resource links provided by NLM:


Further study details as provided by F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Mean change in HbA1c [ Time Frame: Change from baseline after 13 weeks and after 26 weeks ]

Secondary Outcome Measures:
  • Quality of life and treatment satisfaction [ Time Frame: Change from baseline after 13 weeks and after 26 weeks ]
  • Total contact time with study staff (and the PANDIT system, if applicable) [ Time Frame: After 26 weeks ]
  • Proportion of subjects who reach the target of HbA1c < 7.0% [ Time Frame: After 26 weeks ]
  • Mean change in fasting plasma glucose [ Time Frame: Change from baseline after 13 weeks and after 26 weeks ]
  • Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia) [ Time Frame: After 26 weeks ]
  • Frequency of the usage of PANDIT among patients [ Time Frame: After 26 weeks ]
  • Detection of important factors for patient compliance to internet-based self-care interventions [ Time Frame: After 26 weeks ]

Enrollment: 73
Study Start Date: December 2012
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Web-based insulin titration
An online web-based insulin titration algorithm to guide patients in self-titration
Device: Web-based insulin titration
Other Name: PANDIT
No Intervention: Standard care

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female between 18 and 80 years
  • Type 2 diabetes mellitus (diagnosed clinically) for ≥ 6 months
  • Once daily basal insulin therapy usage
  • No restriction on HbA1c or FPG
  • BMI < 40 kg/m2
  • Ability to read and understand the Dutch language
  • Familiarity with the Internet and use of a mobile phone
  • Ability and willingness to adhere to the protocol
  • Ability and willingness to use a web-based insulin self-titration system
  • Confirmed written consent

Exclusion Criteria:

  • Type 1 diabetes
  • Use of systemic corticosteroid in the last three months
  • Recurrent severe hypoglycaemia or hypoglycaemic unawareness
  • Active proliferative diabetic retinopathy
  • Any clinically significant disease or disorder
  • Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
  • Working in night shifts
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715090


Locations
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Frits Holleman, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Publications:
Responsible Party: F Holleman, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01715090     History of Changes
Other Study ID Numbers: NL 40248.018.12
First Submitted: October 22, 2012
First Posted: October 26, 2012
Last Update Posted: November 20, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs