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Model Driven Diabetes Care (MDDC)

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ClinicalTrials.gov Identifier: NCT01774149
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : September 16, 2015
Last Update Posted : September 16, 2015
Sponsor:
Collaborators:
University of Tromso
The Research Council of Norway
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date  ICMJE January 11, 2013
First Posted Date  ICMJE January 23, 2013
Results First Submitted Date  ICMJE June 16, 2015
Results First Posted Date  ICMJE September 16, 2015
Last Update Posted Date September 16, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2013)
Change in the frequency of hyper- and hypo-glycemic events from baseline to week 8-12 and the last 4 weeks of intervention. [ Time Frame: Up to 20 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 recored during baseline (first 4 weeks post-enrollment/start of study), during weeks 8-12 post-enrollment for all participants, and weeks 16-20 post-enrollment for the active comparator group.
Change History Complete list of historical versions of study NCT01774149 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2013)
Change in HbA1c [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 30, 2013)
  • Usability [ Time Frame: 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 [ Time Frame: 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.
Original Other Pre-specified Outcome Measures
 (submitted: January 20, 2013)
  • Usability [ Time Frame: up to 20 weeks post-enrollment ]
    System Usability Scale (SUS) will be applied to assess usability of the approach and recoreded during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).
  • Empowerment [ Time Frame: 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.
  • Acceptability [ Time Frame: Up to 20 weeks post-enrollment. ]
    The Service User Technology Acceptability Questionnaire (SUTAQ) will be applied to assess acceptability of the technology, and recorded during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).
 
Descriptive Information
Brief Title  ICMJE Model Driven Diabetes Care
Official Title  ICMJE Data Driven Feedback as a Method to Improve Glycaemic Control in Type 1 Diabetes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Device: Few Touch Application
    Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
    Other Name: Diabetesdagboka
  • Device: Diastat
    Users get the Few Touch Application with Diastat module activated.
Study Arms  ICMJE
  • Active Comparator: Delayed Diastat
    Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.
    Interventions:
    • Device: Few Touch Application
    • Device: Diastat
  • Experimental: Diastat
    Few Touch Application with Diastat module turned on in week 4 post-enrollment.
    Interventions:
    • Device: Few Touch Application
    • Device: Diastat
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2014)
30
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2013)
40
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01774149
Other Study ID Numbers  ICMJE 2011/1939 (REK)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE
  • University of Tromso
  • The Research Council of Norway
Investigators  ICMJE
Principal Investigator: Stein Olav Skrøvseth, PhD University Hospital of North Norway
PRS Account University Hospital of North Norway
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP