Web-based Insulin Titration - An Efficacy Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01715090
First received: October 22, 2012
Last updated: February 13, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life and treatment satisfaction [ Time Frame: Change from baseline after 13 weeks and after 26 weeks ] [ Designated as safety issue: No ]
  • Total contact time with study staff (and the PANDIT system, if applicable) [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who reach the target of HbA1c < 7.0% [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]
  • Mean change in fasting plasma glucose [ Time Frame: Change from baseline after 13 weeks and after 26 weeks ] [ Designated as safety issue: No ]
  • Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia) [ Time Frame: After 26 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of the usage of PANDIT among patients [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]
  • Detection of important factors for patient compliance to internet-based self-care interventions [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: December 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715090

Contacts
Contact: Frits Holleman, MD PhD 00312065954 f.holleman@amc.uva.nl

Locations
Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands
Principal Investigator: Frits Holleman, MD PhD         
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
Study First Received: October 22, 2012
Last Updated: February 13, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014