Model Driven Diabetes Care

Study Overview
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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.

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]. 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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Few Touch Application
* Device: Diastat


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delayed Diastat<br>Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment. | Device: Few Touch Application<br>* Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.<br>* Other names: Diabetesdagboka;Device: Diastat<br>* Users get the Few Touch Application with Diastat module activated.<br>|
| Experimental: Diastat<br>Few Touch Application with Diastat module turned on in week 4 post-enrollment. | Device: Few Touch Application<br>* Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.<br>* Other names: Diabetesdagboka;Device: Diastat<br>* Users get the Few Touch Application with Diastat module activated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12. | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | 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 |