Diabetes Mellitus, Type 2NCT01715090
Web-based Insulin Titration - An Efficacy Study
A study testing Web-based insulin titration in people with Diabetes Mellitus, Type 2, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Web-based insulin titration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Web-based Insulin Titration: Improving Diabetes Care in the Netherlands. An Efficacy Study.
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Web-based insulin titration
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based insulin titrationDevice
Also called PANDIT
| Study group | Role | What they receive |
|---|---|---|
| Web-based insulin titration | Experimental | An online web-based insulin titration algorithm to guide patients in self-titration Receives: Device: Web-based insulin titration |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in HbA1c
Measured: Change from baseline after 13 weeks and after 26 weeks
Secondary outcomes (7)
Quality of life and treatment satisfaction
Measured: Change from baseline after 13 weeks and after 26 weeks
Total contact time with study staff (and the PANDIT system, if applicable)
Measured: After 26 weeks
Proportion of subjects who reach the target of HbA1c < 7.0%
Measured: After 26 weeks
Mean change in fasting plasma glucose
Measured: 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)
Measured: After 26 weeks
Frequency of the usage of PANDIT among patients
Measured: After 26 weeks
Detection of important factors for patient compliance to internet-based self-care interventions
Measured: After 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Frits Holleman, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715090
- Sponsor's protocol ID
- NL 40248.018.12
- Status last verified
- Nov 2014
- First submitted
- 22 Oct 2012
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21893723Simon 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.
PubMed 22874288Gude 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.
PubMed 22874403
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Insulin Titration: Improving Diabetes Care in the Netherlands. An Efficacy Study.
- ClinicalTrials.gov ID
- NCT01715090
- Acronym / sponsor ID
- NL 40248.018.12
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based insulin titration | Experimental | Device: Web-based insulin titrationAn online web-based insulin titration algorithm to guide patients in self-titration |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based insulin titrationAlso: PANDIT | Device | Web-based insulin titration |
Primary outcome
Mean change in HbA1c
Time frame: Change from baseline after 13 weeks and after 26 weeks
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
- Results publication: PubMed 21893723Simon 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.
- Results publication: PubMed 22874288Simon 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.
- Results publication: PubMed 22874403Gude 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frits Holleman, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based insulin titration in people with Diabetes Mellitus, Type 2, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in HbA1c (time frame: Change from baseline after 13 weeks and after 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715090, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014; AzTrials last refreshed its copy on 5 Nov 2026.