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Web-based Insulin Titration - An Efficacy Study

This study is not yet open for participant recruitment.
Verified October 2012 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: October 25, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

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: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (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
  • HbA1c >7.5% by central laboratory analysis
  • Once daily basal insulin therapy usage ≤1 year or having an indication for basal insulin therapy
  • Fasting glucose values > 7 mmol/L on three consecutive measurements
  • 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
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 Not yet 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: October 25, 2012
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013