Type 1 Diabetes MellitusDCT1ANCT02596204
Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring
A study testing Weekly Review and FitBit in people with Type 1 Diabetes Mellitus, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
With emerging mobile technology, sharing glucose, insulin and sensor data with the clinic for frequent and timely monitoring is now feasible. The investigators propose to leverage this new technology to provide children and families with appropriate interventions to help manage their diabetes. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Weekly Review and FitBit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 diabetes, using an insulin pump (Medtronic, Omnipod, Animas)
- Duration of diabetes >1 year
- Age: 8-17 years of age, inclusive.
- Hemoglobin A1c 8.0-10.0% at baseline visit, inclusive.
- Seen in the McNeely Diabetes Clinic within the past 6 months.
- The family/child is testing blood glucose at least 4 times a day.
- The family has a smart phone and service.
Who cannot join
- The child is not using insulin for management of diabetes.
- The child uses multiple daily injections of insulin.
- The child is unwilling to use the wearable device, or the family is unwilling or unable to upload glucose and insulin data on a routine basis
- The family is unwilling or unable to upload data from devices such as meter, pump, sensor, wearable device.
- Diagnosis of a mental health disorder.
- Parent/child does not speak English as the device software is only available in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102
About this study
With emerging mobile technology, sharing glucose, insulin and sensor data with the clinic for frequent and timely monitoring is now feasible. The investigators propose to leverage this new technology to provide children and families with appropriate interventions to help manage their diabetes.
Read the detailed description
The investigators will collect insulin dosing via pump records, blood glucose meter, continuous glucose sensor, activity, heart rate, and sleep data on a weekly basis from 100 children with diabetes. The investigators hypothesize that with the collection and analysis of insulin, blood glucose, sensor, activity, heart rate and sleep data in children with diabetes the investigators can identify glucose patterns and predictors of acute events.
The 100 children will be randomized to either conventional therapy (data upload group) or intensive remote therapy (weekly review group). Conventional therapy will consist of routine quarterly visits to the clinic and as-needed communication with the diabetes staff, initiated by the family, between study visits. Intensive remote therapy will consist of routine quarterly visits to the clinic along with weekly remote review of insulin and blood glucose data by the research staff, and additional communication with the family, initiated by the diabetes staff as needed, between visits. The investigators hypothesize that with weekly, manual review of real-time insulin, glucose, and activity data in children with diabetes, and recommended regimen changes based on the data, the investigators will be able to lower HbA1c values in children in the weekly review group as compared to children in the data upload group.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Weekly Review, FitBit
- 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.
Weekly ReviewOther
Subjects will wear a FitBit activity monitor and continue to use their insulin pump. Fitbit, pump and sensor (if applicable) data will be uploaded at least weekly. For subjects in the weekly review group, research staff (CDE, NP and/or MD) will review uploaded blood glucose, pump, and available sensor, activity and sleep data on a weekly basis. If glucose patterns are identified which suggest a change to diabetes management (ie insulin dose changes), the family will be contacted by text, email or telephone to review glucose patterns and to review staff recommendations.
FitBitDevice
All subjects will wear a FitBit activity monitor.
| Study group | Role | What they receive |
|---|---|---|
| Data Upload | Active comparator | Subjects will wear a FitBit activity monitor and continue to use their insulin pump. FitBit, pump and sensor (if applicable) data will be uploaded at least weekly. Subjects will continue to receive usual diabetes care. Phone calls and emails to the diabetes clinic will be initiated by the family. Receives: Device: FitBit |
| Weekly Review | Experimental | Subjects will wear a FitBit activity monitor and continue to use their insulin pump. FitBit, pump and sensor (if applicable) data will be uploaded at least weekly. For subjects in the weekly review group, research staff (diabetes educator, nurse practitioner and/or physician) will review uploaded blood glucose, pump, and available sensor, activity and sleep data on a weekly basis. If glucose patterns are identified which suggest a change to diabetes management (ie insulin dose changes), the family will be contacted by text, email or telephone to review glucose patterns and to review staff recommendations. Receives: Other: Weekly Review; Device: FitBit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
Change in HbA1c from baseline to 6 months
Measured: From baseline to 6 months
Secondary outcomes (6)
Health care utilization
The investigators will track the number of phone calls to clinic, emergency department visits and hospitalizations over 6 months between data upload and weekly review groups
Measured: 6 months
PedsQL Inventory (PedsQL)
The investigators will assess change in the PedsQL (Peds Quality of Life) Inventory from baseline to 6 months between data upload and weekly review groups.
Measured: 6 months
Diabetes Family Conflict Scale (DFCS)
The investigators will assess change in the Diabetes Family Conflict Scale from baseline to 6 months between data upload and weekly review groups.
Measured: 6 months
Center for Epidemiology Scale- Depression (CES-D) survey
The investigators will assess change in the Center for Epidemiology Scale- Depression from baseline to 6 months between data upload and weekly review groups.
Measured: 6 months
Problem Areas in Diabetes (PAID) survey
The investigators will assess change in the Problem Areas in Diabetes- pediatrics and Problem Areas in Diabetes- parent from baseline to 6 months between data upload and weekly review groups.
Measured: 6 months
Change in Hemoglobin A1c
Change in hemoglobin A1c from 6 months (end of active intervention) to 9 months
Measured: Change from 6 months to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- UnitedHealth Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596204
- Sponsor's protocol ID
- 1506-073
- Acronym
- DCT1A
- Status last verified
- Jul 2017
- First submitted
- 5 Oct 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring
- ClinicalTrials.gov ID
- NCT02596204
- Acronym / sponsor ID
- DCT1A / 1506-073
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Collaborators
- UnitedHealth Group
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With emerging mobile technology, sharing glucose, insulin and sensor data with the clinic for frequent and timely monitoring is now feasible. The investigators propose to leverage this new technology to provide children and families with appropriate interventions to help manage their diabetes.
Detailed description
The investigators will collect insulin dosing via pump records, blood glucose meter, continuous glucose sensor, activity, heart rate, and sleep data on a weekly basis from 100 children with diabetes. The investigators hypothesize that with the collection and analysis of insulin, blood glucose, sensor, activity, heart rate and sleep data in children with diabetes the investigators can identify glucose patterns and predictors of acute events.
The 100 children will be randomized to either conventional therapy (data upload group) or intensive remote therapy (weekly review group). Conventional therapy will consist of routine quarterly visits to the clinic and as-needed communication with the diabetes staff, initiated by the family, between study visits. Intensive remote therapy will consist of routine quarterly visits to the clinic along with weekly remote review of insulin and blood glucose data by the research staff, and additional communication with the family, initiated by the diabetes staff as needed, between visits. The investigators hypothesize that with weekly, manual review of real-time insulin, glucose, and activity data in children with diabetes, and recommended regimen changes based on the data, the investigators will be able to lower HbA1c values in children in the weekly review group as compared to children in the data upload group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Data Upload | Active comparator | Device: FitBitSubjects will wear a FitBit activity monitor and continue to use their insulin pump. FitBit, pump and sensor (if applicable) data will be uploaded at least weekly. Subjects will continue to receive usual diabetes care. Phone calls and emails to the diabetes clinic will be initiated by the family. |
| Weekly Review | Experimental | Other: Weekly Review, Device: FitBitSubjects will wear a FitBit activity monitor and continue to use their insulin pump. FitBit, pump and sensor (if applicable) data will be uploaded at least weekly. For subjects in the weekly review group, research staff (diabetes educator, nurse practitioner and/or physician) will review uploaded blood glucose, pump, and available sensor, activity and sleep data on a weekly basis. If glucose patterns are identified which suggest a change to diabetes management (ie insulin dose changes), the family will be contacted by text, email or telephone to review glucose patterns and to review staff recommendations. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Type 1 diabetes, using an insulin pump (Medtronic, Omnipod, Animas)
- Duration of diabetes >1 year
- Age: 8-17 years of age, inclusive.
- Hemoglobin A1c 8.0-10.0% at baseline visit, inclusive.
- Seen in the McNeely Diabetes Clinic within the past 6 months.
Key exclusion criteria (6 listed)
- The child is not using insulin for management of diabetes.
- The child uses multiple daily injections of insulin.
- The child is unwilling to use the wearable device, or the family is unwilling or unable to upload glucose and insulin data on a routine basis
- The family is unwilling or unable to upload data from devices such as meter, pump, sensor, wearable device.
- Diagnosis of a mental health disorder.
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 |
|---|---|---|
| Weekly ReviewSubjects will wear a FitBit activity monitor and continue to use their insulin pump. Fitbit, pump and sensor (if applicable) data will be uploaded at least weekly. For subjects in the weekly review group, research staff (CDE, NP and/or MD) will review uploaded blood glucose, pump, and available sensor, activity and sleep data on a weekly basis. If glucose patterns are identified which suggest a change to diabetes management (ie insulin dose changes), the family will be contacted by text, email or telephone to review glucose patterns and to review staff recommendations. | Other | Weekly Review |
| FitBitAll subjects will wear a FitBit activity monitor. | Device | Data Upload, Weekly Review |
Primary outcome
Change in Hemoglobin A1c
Time frame: From baseline to 6 months
Change in HbA1c from baseline to 6 months
6 secondary outcomes
Health care utilization
Time frame: 6 months
PedsQL Inventory (PedsQL)
Time frame: 6 months
Diabetes Family Conflict Scale (DFCS)
Time frame: 6 months
Center for Epidemiology Scale- Depression (CES-D) survey
Time frame: 6 months
Problem Areas in Diabetes (PAID) survey
Time frame: 6 months
Change in Hemoglobin A1c
Time frame: Change from 6 months to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly Review and FitBit in people with Type 1 Diabetes Mellitus, run by Children's Hospitals and Clinics of Minnesota 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 7 inclusion and 6 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 1 Aug 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Hemoglobin A1c (time frame: From baseline to 6 months). 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 1 Aug 2017.