Model Driven Diabetes Care (MDDC)

August 17, 2015 updated by: University Hospital of North Norway

Data Driven Feedback as a Method to Improve Glycaemic Control in Type 1 Diabetes

Patients with Diabetes Mellitus Type 1 using electronic self-help tools typically registers a large amount of data on their disease. The study intends to see if giving advanced feedback on these data can improve their blood glucose management.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All patients will be given access to a mobile phone with the diabetes diary known as the Few Touch Application (FTA) installed. They may use either their own compatible Android handsets, or provided handsets. The study uses a delayed start design. Participants are randomized into two groups, who get access to the module "Diastat" after 4 and 12 weeks post-enrollment respectively. Each group uses the FTA with Diastat for 8 weeks post-intervention (i.e. access to Diastat).

Diastat is a module within FTA that provides data-driven feedback to the patients using their own data. This module is based on the data recorded in a previous trial [1]. Three submodules are part of Diastat; Periodicity detection and visualization, multiscale trend detection based on the c-SiZer algorithm [2], and situation matching for insulin dosage [3].

  1. Skrøvseth SO et al, Diabetes Technol Ther (2012)
  2. Skrøvseth SO et al, PLoS ONE (2012)
  3. Skrøvseth SO et al, Accepted for Advanced Technologies and Treatments for Diabetes, Paris, France, 2013.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsø, Norway, 9038
        • University Hopital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis with Diabetes Mellitus type 1 for at least one year.
  • Age over 18 years
  • Has basic familiarity with mobile phones, and uses mobile phone on a daily basis.

Exclusion Criteria:

  • Severe complications due to their diabetes.
  • Unable to understand or conform to the guidelines when presented with the phone's software.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Delayed Diastat
Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.
Device: Few Touch Application
Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Other Names:
  • Diabetesdagboka
Device: Diastat
Users get the Few Touch Application with Diastat module activated.
Experimental: Diastat
Few Touch Application with Diastat module turned on in week 4 post-enrollment.
Device: Few Touch Application
Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Other Names:
  • Diabetesdagboka
Device: Diastat
Users get the Few Touch Application with Diastat module activated.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.
Time Frame: Up to 12 weeks post-enrollment
The number of self-measured blood glucose values < 4 mmol/L (72 mg/dL) or > 15 mmol/L (270 mg/dL) will be recorded during baseline (first 4 weeks post-enrollment/start of study) and during weeks 8-12 post-enrollment for all participants.
Up to 12 weeks post-enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: up to 20 weeks post-enrollment
HbA1c will be measured at the start of the study (week 1 post-enrollment) and during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).
up to 20 weeks post-enrollment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Usability
Time Frame: up to 20 weeks post-enrollment
System Usability Scale (SUS) will be applied to assess usability of the approach and recorded during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).
up to 20 weeks post-enrollment
Empowerment
Time Frame: Up to 12 weeks post-enrollment.
Diabetes Empowerment Scale-Short Form (DES-SF) will be used to assess empowerment at the start of the study (week 1 post-enrollment) and during week 12 of intervention.
Up to 12 weeks post-enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital of North Norway

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Tromso
The Research Council of Norway

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stein Olav Skrøvseth, PhD, University Hospital of North Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011/1939 (REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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