Model Driven Diabetes Care

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Delayed Diastat

Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.

Group Type ACTIVE_COMPARATOR

Few Touch Application

Intervention Type DEVICE

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

Diastat

Intervention Type DEVICE

Users get the Few Touch Application with Diastat module activated.

Diastat

Few Touch Application with Diastat module turned on in week 4 post-enrollment.

Group Type EXPERIMENTAL

Few Touch Application

Intervention Type DEVICE

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

Diastat

Intervention Type DEVICE

Users get the Few Touch Application with Diastat module activated.

Interventions

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Few Touch Application

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

Intervention Type DEVICE

Diastat

Users get the Few Touch Application with Diastat module activated.

Intervention Type DEVICE

Other Intervention Names

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Diabetesdagboka

Eligibility Criteria

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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.