Trial Outcomes & Findings for Model Driven Diabetes Care (NCT NCT01774149)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Up to 12 weeks post-enrollment

Results posted on

2015-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	15	15
Overall Study COMPLETED	14	12
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Model Driven Diabetes Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delayed Diastat n=15 Participants 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.	Diastat n=15 Participants 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 n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	38.3 years STANDARD_DEVIATION 7.3 • n=5 Participants	41.1 years STANDARD_DEVIATION 13.5 • n=7 Participants	39.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Norway	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
HbA1c	8.06 % STANDARD_DEVIATION 1.32 • n=5 Participants	8.33 % STANDARD_DEVIATION 0.87 • n=7 Participants	8.20 % STANDARD_DEVIATION 1.11 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Delayed Diastat n=14 Participants 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.	Diastat n=14 Participants 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.
Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.	-18 Events Interval -25.0 to -13.0	-7.5 Events Interval -15.5 to -0.5

SECONDARY outcome

Timeframe: up to 20 weeks post-enrollment

Population: 11 participants in each group met for measurement of HbA1c. Reasons for not meeting was not recorded.

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).

Outcome measures

Outcome measures
Measure	Delayed Diastat n=11 Participants 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.	Diastat n=11 Participants 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.
Change in HbA1c	-0.57 Percentage points Interval -1.1 to -0.05	-0.63 Percentage points Interval -1.02 to -0.24

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Delayed Diastat

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diastat

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stein Olav Skrøvseth

Norwegian Center for Integrated Care and Telemedicine

Phone: +4795805841

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place