Model Driven Diabetes Care (MDDC)

University Hospital of North Norway

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Diastat; Device: Few Touch Application

Study type: Interventional

Funder types: Other

Identifiers

NCT01774149

2011/1939 (REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Delayed Diastat

Active Comparator group

Description:

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

Treatment:

Device: Few Touch Application

Device: Diastat

Diastat

Experimental group

Description:

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

Treatment:

Device: Few Touch Application

Device: Diastat