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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Diabetes Mellitus, Type 1
Interventions Device: Few Touch Application
Device: Diastat
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Delayed Diastat Diastat
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 15 15
Completed 14 12
Not Completed 1 3
Arm/Group Title Delayed Diastat Diastat Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
14
  93.3%
29
  96.7%
>=65 years
0
   0.0%
1
   6.7%
1
   3.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
38.3  (7.3) 41.1  (13.5) 39.7  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
9
  60.0%
10
  66.7%
19
  63.3%
Male
6
  40.0%
5
  33.3%
11
  36.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 15 participants 15 participants 30 participants
15 15 30
HbA1c  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 15 participants 15 participants 30 participants
8.06  (1.32) 8.33  (0.87) 8.20  (1.11)
1.Primary Outcome
Title Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
14 participants in each group were active users and had sufficient data to be analyzed for the outcome.
Arm/Group Title Delayed Diastat Diastat
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 14 14
Mean (95% Confidence Interval)
Unit of Measure: Events
-18
(-25 to -13)
-7.5
(-15.5 to -.5)
2.Secondary Outcome
Title Change in HbA1c
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
11 participants in each group met for measurement of HbA1c. Reasons for not meeting was not recorded.
Arm/Group Title Delayed Diastat Diastat
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 11 11
Mean (95% Confidence Interval)
Unit of Measure: Percentage points
-0.57
(-1.1 to -.05)
-0.63
(-1.02 to -0.24)
3.Other Pre-specified Outcome
Title Usability
Hide Description 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
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Empowerment
Hide Description 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.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Delayed Diastat Diastat
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Delayed Diastat Diastat
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Delayed Diastat Diastat
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Delayed Diastat Diastat
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Stein Olav Skrøvseth
Organization: Norwegian Center for Integrated Care and Telemedicine
Phone: +4795805841
EMail: stein.olav.skrovseth@telemed.no
Layout table for additonal information
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01774149     History of Changes
Other Study ID Numbers: 2011/1939 (REK)
First Submitted: January 11, 2013
First Posted: January 23, 2013
Results First Submitted: June 16, 2015
Results First Posted: September 16, 2015
Last Update Posted: September 16, 2015