Type 1 Diabetes
Conditions
Keywords
mobile technology, cell phones, type 1 diabetes
Brief summary
Among those with type I diabetes, adolescents can be among the worst at achieving glycemic control. Behaviors normal in adolescent development (e.g., developing independence, rejecting parental norms in favor of peers) can be at odds with the demands of effective diabetes self-management. Modifying the family and patient interaction should be a crucial component to improving the ability of an adolescent to manage his or her diabetes. Mobile technology is becoming more popular in medicine, and adolescents, as a group are more inclined to accept technology as an adjunct to care. Mobile technology that links adolescents to health providers could help them to work through complex information that must be processed to make good decisions. Since this assistance comes from health professionals, it should help relax parents somewhat, thus reducing problems associated with parental hypervigilance and manipulation of the regimen to avoid problems of hypoglycemia. Parental-child conflicts may therefore be reduced by using cell phone glucose monitoring technology that directly reports self-blood glucose monitoring data to providers and creates a communication link to discuss therapeutic options. This study investigates whether the use of mobile technology, in the form of a cell phone glucose monitoring system, will help reduce the need for parents to assert behavioral control, which can negatively impact adolescent diabetes self-management. The study will also determine whether adolescents report improved quality of life, demonstrate competence in diabetes management, and are able to achieve better control of their diabetes.
Detailed description
Among patients with type I diabetes, adolescents struggle the most with self-management, which often results in poor glycemic control. Optimizing parent-patient interaction is crucial to improving self-management. Mobile technology with integrated glucose monitoring capability that links adolescents to providers may reduce parental hypervigilance and assist them to better understand self-management. . This study will investigate a novel cell phone glucose monitoring system (CPGM) with the following specific aims: 1. To establish feasibility of a CPGM system as a component of an adolescent diabetes management program. 2. To determine if the technology will improve a) quality of parent-child relationship, b) patient quality of life, c) competence in diabetes management, and d) metabolic control. 3. To gather preliminary data for development of future intervention studies. 120 adolescents with type I diabetes will be randomly assigned to either an experimental or control group. Experimental subjects will use the CPGM which will transmit all blood glucose data to a host computer. A nurse practitioner in the pediatric endocrinology clinic will determine need for telephone contacts based on evaluation of transmitted data. Subjects might be telephoned to discuss possible regimen adjustments, need for clinic visits, or referrals to additional services. Subjects will also be able to initiate contact with the project nurse. Control subjects will continue to receive standard care. . This study will assess the effect of the intervention in the four primary domains stated in the specific aims. These domains will be measured at baseline, three months, and six months.
Interventions
DEVICEGlucoPak
We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.
DEVICECell Phone
We will provide cell phones and access to the clinic to facilitate communications
OTHERUsual Care
This intervention was usual care, without either device.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Adolescent with thpe 1 diabetes 2. Adolescents in the study must intend to remain in the care of participating clinics for the extent of the study 3. Adolescents in the study must be literate in English.
Exclusion criteria
1. Only one patient per family can participate 2. Patients who participated in preliminary studies related to the development of the cell phone technology will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Parent-child Relationship | Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Glucopak Cell Phone and Intensive Monitoring Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic. | 40 |
| Cell Phone Only 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. | 37 |
| Usual Care Usual care, without cell phone or glucopak | 28 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Glucopak Cell Phone and Intensive Monitoring | Cell Phone Only | Usual Care | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 40 Participants | 37 Participants | 28 Participants | 105 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 40 participants | 37 participants | 28 participants | 105 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 13 Participants | 53 Participants |
| Sex: Female, Male Male | 20 Participants | 17 Participants | 15 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 37 | 0 / 28 |
| serious Total, serious adverse events | 0 / 39 | 0 / 37 | 0 / 28 |
Outcome results
Primary
Quality of Parent-child Relationship
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Glucopak Cell Phone and Intensive Monitoring | Quality of Parent-child Relationship | 0.22 units on a scale |
| Cell Phone Only | Quality of Parent-child Relationship | -3.24 units on a scale |
| Usual Care | Quality of Parent-child Relationship | -0.59 units on a scale |