Trial Outcomes & Findings for Mobile Communication Technology for Adolescents With Diabetes (NCT NCT00605839)

Results Overview

The Cornell Parent Behavior Description Scale was used to measure the antecedents and consequences of children's perceptions of the behavior of their parents towards them. Each of 14 subscales is scored from 0-10. The potential range of the total score is therefore 0 (fewest behaviors) to 140 (most behaviors). We used the total score, which is equivalent to the sums of the subscales, and calculated the change from baseline to 6 months. The range of the change is given as a 95% CI. A change of zero would indicate no change. A positive number is a worsening , and a negative number indicates an improvement.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

105 participants

Primary outcome timeframe

Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted.

Results posted on

2017-10-11

Participant Flow

Subjects were recruited from the pediatric diabetes clinics at the James Whitcomb Riley Hospital for Children in Indianapolis, IN. Adolescents with type 1 diabetes between the ages of 14 and 18 years living with at least one parent participated.

Participant milestones

Participant milestones
Measure	Glucopak Cell Phone and Intensive Monitoring Glucopak cell phone and intensive monitoring. Participants use the experimental device and are actively monitored by the clinic.	Cell Phone Only Cell phone only. Participants are given cell phones and encouraged to keep in contact with the clinic.	Usual Care Usual care, without Glucopak or cell phones.
Overall Study STARTED	40	37	28
Overall Study COMPLETED	39	37	28
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Glucopak Cell Phone and Intensive Monitoring Glucopak cell phone and intensive monitoring. Participants use the experimental device and are actively monitored by the clinic.	Cell Phone Only Cell phone only. Participants are given cell phones and encouraged to keep in contact with the clinic.	Usual Care Usual care, without Glucopak or cell phones.
Overall Study Protocol Violation	1	0	0

Baseline Characteristics

Mobile Communication Technology for Adolescents With Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glucopak Cell Phone and Intensive Monitoring n=40 Participants Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.	Cell Phone Only n=37 Participants Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.	Usual Care n=28 Participants Usual care, without cell phone or glucopak	Total n=105 Participants Total of all reporting groups
Age, Categorical <=18 years	40 Participants n=5 Participants	37 Participants n=7 Participants	28 Participants n=5 Participants	105 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	13 Participants n=5 Participants	53 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	52 Participants n=4 Participants
Region of Enrollment United States	40 participants n=5 Participants	37 participants n=7 Participants	28 participants n=5 Participants	105 participants n=4 Participants

PRIMARY outcome

Timeframe: Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted.

Population: Everyone who completed the study

The Cornell Parent Behavior Description Scale was used to measure the antecedents and consequences of children's perceptions of the behavior of their parents towards them. Each of 14 subscales is scored from 0-10. The potential range of the total score is therefore 0 (fewest behaviors) to 140 (most behaviors). We used the total score, which is equivalent to the sums of the subscales, and calculated the change from baseline to 6 months. The range of the change is given as a 95% CI. A change of zero would indicate no change. A positive number is a worsening , and a negative number indicates an improvement.

Outcome measures

Outcome measures
Measure	Glucopak Cell Phone and Intensive Monitoring n=39 Participants Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.	Cell Phone Only n=37 Participants Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.	Usual Care n=28 Participants Usual care, without cell phone or glucopak
Quality of Parent-child Relationship	0.22 units on a scale Interval -2.11 to 2.54	-3.24 units on a scale Interval -6.12 to -0.36	-0.59 units on a scale Interval -5.41 to 4.23

Adverse Events

Glucopak Cell Phone and Intensive Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cell Phone Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Aaron E. Carroll

Indiana University School of Medicine

Phone: 3172780552

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place