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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucopak Care | Experimental | Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic. |
|
| Cell Phone Care | Active Comparator | 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 | Placebo Comparator | Usual care, without cell phone or glucopak |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlucoPak | Device | We will be giving participants Glucopak devices and monitoring them closely over the 6 month period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David G Marrero, PhD | Indiana University | Principal Investigator |
| Aaron E Carroll, MD, MS | Indiana University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital Diabetes Clinics | Indianapolis | Indiana | 46202 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glucopak Cell Phone and Intensive Monitoring | Glucopak cell phone and intensive monitoring. Participants use the experimental device and are actively monitored by the clinic. |
| FG001 | Cell Phone Only | Cell phone only. Participants are given cell phones and encouraged to keep in contact with the clinic. |
| FG002 | Usual Care | Usual care, without Glucopak or cell phones. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Cell Phone Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Everyone who completed the study | Posted | Mean | 95% Confidence Interval | units on a scale | Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This was a small pilot study to generate results for further work.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron E. Carroll | Indiana University School of Medicine | 3172780552 | aaecarro@iupui.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Cell Phone | Device | We will provide cell phones and access to the clinic to facilitate communications |
|
| Usual Care | Other | This intervention was usual care, without either device. |
|
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.
| BG002 | Usual Care | Usual care, without cell phone or glucopak |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
| OG001 | 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. |
| OG002 | Usual Care | Usual care, without cell phone or glucopak |
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | 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. | 0 | 37 | 0 | 37 |
| EG002 | Usual Care | Usual care, without cell phone or glucopak | 0 | 28 | 0 | 28 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |