Type 1 DiabetesNCT00605839
Mobile Communication Technology for Adolescents With Diabetes
A study testing GlucoPak and Cell Phone in people with Type 1 Diabetes, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- GlucoPak and Cell Phone
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent with thpe 1 diabetes
- Adolescents in the study must intend to remain in the care of participating clinics for the extent of the study
- Adolescents in the study must be literate in English.
Who cannot join
- Only one patient per family can participate
- Patients who participated in preliminary studies related to the development of the cell phone technology will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital Diabetes Clinics
Indianapolis, Indiana, 46202
About this study
Official title: Adapting Mobile Communication Technology to Improve the Management of Adolescents With Diabetes
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.
Read the 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:
- To establish feasibility of a CPGM system as a component of an adolescent diabetes management program.
- 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.
- 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.
- Conditions
- Type 1 Diabetes
- Being tested
- GlucoPak, Cell Phone, Usual Care
- Keywords
- mobile technology, cell phones, type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoPakDevice
We will be giving participants Glucopak devices and monitoring them closely over the 6 month period.
Cell PhoneDevice
We will provide cell phones and access to the clinic to facilitate communications
Usual CareOther
This intervention was usual care, without either device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: GlucoPak |
| 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. Receives: Device: Cell Phone |
| Usual Care | Placebo comparator | Usual care, without cell phone or glucopak Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Carroll, Indiana University
- Investigators
- David G Marrero, PhD, Principal investigator, Indiana UniversityAaron E Carroll, MD, MS, Study director, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605839
- Sponsor's protocol ID
- ADA-HenryBecton-DGM-01
- Status last verified
- Sep 2017
- First submitted
- 17 Jan 2008
- Last updated
- 11 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Mobile Communication Technology to Improve the Management of Adolescents With Diabetes
- ClinicalTrials.gov ID
- NCT00605839
- Acronym / sponsor ID
- ADA-HenryBecton-DGM-01
- Conditions
- Type 1 Diabetes
- Keywords
- mobile technology, cell phones, type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Posted 20 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To establish feasibility of a CPGM system as a component of an adolescent diabetes management program.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucopak Care | Experimental | Device: GlucoPakGlucopak 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 | Device: Cell PhoneCell 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 | Other: Usual CareUsual care, without cell phone or glucopak |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescent with thpe 1 diabetes
- Adolescents in the study must intend to remain in the care of participating clinics for the extent of the study
- Adolescents in the study must be literate in English.
Key exclusion criteria (2 listed)
- Only one patient per family can participate
- Patients who participated in preliminary studies related to the development of the cell phone technology will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucoPakWe will be giving participants Glucopak devices and monitoring them closely over the 6 month period. | Device | Glucopak Care |
| Cell PhoneWe will provide cell phones and access to the clinic to facilitate communications | Device | Cell Phone Care |
| Usual CareThis intervention was usual care, without either device. | Other | Usual Care |
Primary outcome
Quality of Parent-child Relationship
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Marrero, PhD principal investigator
Indiana University
Aaron E Carroll, MD, MS study director
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlucoPak and Cell Phone in people with Type 1 Diabetes, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Parent-child Relationship (time frame: Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.