Model Driven Diabetes Care (MDDC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Tromso
The Research Council of Norway
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01774149
First received: January 11, 2013
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 1
Device: Few Touch Application
Device: Diastat

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Data Driven Feedback as a Method to Improve Glycaemic Control in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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), during weeks 8-12 post-enrollment for all participants, and weeks 16-20 post-enrollment for the active comparator group.


Secondary Outcome Measures:
  • Change in HbA1c [ Time Frame: up to 20 weeks post-enrollment ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Usability [ Time Frame: up to 20 weeks post-enrollment ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Delayed Diastat
Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.
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.
Experimental: Diastat
Few Touch Application with Diastat module turned on in week 4 post-enrollment.
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774149

Locations
Norway
University Hopital of North Norway
Tromsø, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
The Research Council of Norway
Investigators
Principal Investigator: Stein Olav Skrøvseth, PhD University Hospital of North Norway
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01774149     History of Changes
Other Study ID Numbers: 2011/1939 (REK)
Study First Received: January 11, 2013
Last Updated: April 30, 2013
Health Authority: Norway: Regional Ethics Commitee
Norway: Data Protection Authority

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Diazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 24, 2014