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Web-based Insulin Titration - An Efficacy Study

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Device: Web-based insulin titration

Study type

Interventional

Funder types

Other

Identifiers

NCT01715090
NL 40248.018.12

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

73 participants in 2 patient groups

Web-based insulin titration
Experimental group
Description:
An online web-based insulin titration algorithm to guide patients in self-titration
Treatment:
Device: Web-based insulin titration
Standard care
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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