Diabetes Mellitus, Type 1
Conditions
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.
Interventions
DEVICEFew Touch Application
Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
DEVICEDiastat
Users get the Few Touch Application with Diastat module activated.
Sponsors
University of Tromso
The Research Council of Norway
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usability | 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). |
| Empowerment | 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. |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Delayed Diastat Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated. | 15 |
| Diastat Few Touch Application with Diastat module turned on in week 4 post-enrollment.
Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
Diastat: Users get the Few Touch Application with Diastat module activated. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Delayed Diastat | Diastat | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 14 Participants | 29 Participants |
| Age, Continuous | 38.3 years STANDARD_DEVIATION 7.3 | 41.1 years STANDARD_DEVIATION 13.5 | 39.7 years STANDARD_DEVIATION 10.8 |
| HbA1c | 8.06 % STANDARD_DEVIATION 1.32 | 8.33 % STANDARD_DEVIATION 0.87 | 8.20 % STANDARD_DEVIATION 1.11 |
| Region of Enrollment Norway | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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.
Time frame: Up to 12 weeks post-enrollment
Population: 14 participants in each group were active users and had sufficient data to be analyzed for the outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Delayed Diastat | Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12. | -18 Events |
| Diastat | Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12. | -7.5 Events |
Secondary
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).
Time frame: up to 20 weeks post-enrollment
Population: 11 participants in each group met for measurement of HbA1c. Reasons for not meeting was not recorded.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Delayed Diastat | Change in HbA1c | -0.57 Percentage points |
| Diastat | Change in HbA1c | -0.63 Percentage points |
Other Pre-specified
Empowerment
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.
Time frame: Up to 12 weeks post-enrollment.
Other Pre-specified
Usability
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).
Time frame: up to 20 weeks post-enrollment