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Completed

NCT Number: NCT01774149

Model Driven Diabetes Care

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hopital of North Norway

Tromsø, 9038, Norway

About this study

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].

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Few Touch Application

Device

Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.

Other names: Diabetesdagboka

Diastat

Device

Users get the Few Touch Application with Diastat module activated.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Other outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • The Research Council of Norway
  • University of Tromso

Registry information

Official study title

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

Acronym: MDDC

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2013
Registry last updated
Sep 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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