NCT01715090

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

1.5 years

First QC Date

October 22, 2012

Last Update Submit

November 19, 2014

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Mean change in HbA1c

    Change from baseline after 13 weeks and after 26 weeks

Secondary Outcomes (7)

  • Quality of life and treatment satisfaction

    Change from baseline after 13 weeks and after 26 weeks

  • Total contact time with study staff (and the PANDIT system, if applicable)

    After 26 weeks

  • Proportion of subjects who reach the target of HbA1c < 7.0%

    After 26 weeks

  • Mean change in fasting plasma glucose

    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)

    After 26 weeks

  • +2 more secondary outcomes

Study Arms (2)

Web-based insulin titration

EXPERIMENTAL

An online web-based insulin titration algorithm to guide patients in self-titration

Device: Web-based insulin titration

Standard care

NO INTERVENTION

Interventions

Web-based insulin titrationDEVICE
Also known as: PANDIT
Web-based insulin titration

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, Netherlands

Location

Related Publications (3)

  • Simon AC, Holleman F, Hoekstra JB, De Clercq PA, Lemkes BA, Hermanides J, Peek N. Development of a web-based decision support system for insulin self-titration. Stud Health Technol Inform. 2011;169:103-7.

    PMID: 21893723RESULT

  • Simon AC, Holleman F, Gude WT, Hoekstra JB, Peek N. Safety of a web-based insulin titration system for patients with type 2 diabetes mellitus - pilot study. Stud Health Technol Inform. 2012;180:731-5.

    PMID: 22874288RESULT

  • Gude WT, Simon AC, Peute LW, Holleman F, Hoekstra JB, Peek N, Jaspers MW. Formative usability evaluation of a web-based insulin self-titration system: preliminary results. Stud Health Technol Inform. 2012;180:1209-11.

    PMID: 22874403RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Frits Holleman, MD PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 26, 2012

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

NL(1)