Model Driven Diabetes Care

Not Applicable

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Delayed Diastat	Few Touch Application	Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.
Diastat	Few Touch Application	Few Touch Application with Diastat module turned on in week 4 post-enrollment.
Diastat	Diastat	Few Touch Application with Diastat module turned on in week 4 post-enrollment.
Delayed Diastat	Diastat	Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.

Primary Outcome Measures

Name	Time	Method
Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.	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 Outcome Measures

Name	Time	Method
Change in HbA1c	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).