Biomedical TechnologyNCT04051632
Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)
An observational study of Biomedical Technology and Type 1 Diabetes, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Observational study of patients at Boston Childrens Hospital with type 1 diabetes (T1D) who elected to treat their diabetes with the Medtronic 670 G hybrid closed loop insulin pump. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Biomedical Technology, Type 1 Diabetes
- What is being tested?
- Medtronic 670G insulin pump
- Type of treatment
- Medical device
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2018to 30 Jul 2019
- Phase
- Observational
- 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 5 to 25 years
- All sexes
- Child, Adult
Study population: Single institution clinic population.
Who may be able to join
- clinical diagnosis of T1D
- patient of Boston Childrens Hospital diabetes program
- deemed to be adequate candidates for hybrid closed loop technology by their diabetes health care team
- patient received Medtronic 670G training at Boston Childrens Hospital
- patient received follow up diabetes care at Boston Childrens Hospital for at least 3 months after starting on the 670G
Who cannot join
- patients not trained at Boston Childrens Hospital or self started
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Childrens Hospital
Boston, Massachusetts, 02115
About this study
Observational study of patients at Boston Childrens Hospital with type 1 diabetes (T1D) who elected to treat their diabetes with the Medtronic 670 G hybrid closed loop insulin pump.
Read the detailed description
Outcome study of 90-100 patients with type 1 diabetes who elected to use the Medtronic 670G.
Major outcome measure was to assess the percent of patients who were able to successfully continue to use the 670G technology over time.
Additional outcome variables included hemoglobin A1c pre and post treatment with the 670G, time in desired glucose range 70-180.
- Conditions
- Biomedical Technology, Type 1 Diabetes
- Being tested
- Medtronic 670G insulin pump
- Keywords
- Medtronic 670G
- 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.
Medtronic 670G insulin pumpDevice
- percent of patients who continue to use Medtronic 670G over time
- impact of 670G on glycemic control: hemoglobin A1c, time in range
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes patients treated with the Medtronic 670G | Type 1 Diabetes patients treated with the Medtronic 670G at Boston Childrens Hospital Receives: Device: Medtronic 670G insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful implementation of hybrid closed loop technology
Percent of Type 1 Diabetes patients who were properly trained on the use of the 670G that continue to use Hybrid Closed Loop technology at 0, 6, 12, 18 and 24 months post training.
Measured: 0-24 months
Secondary outcomes (2)
Impact of hybrid closed loop technology on glycemic control
Assess impact of hybrid closed loop technology on glycemic control by comparing hemoglobin A1c measurements 0-6 months prior to treatment versus 0-6, 6-12, 12-18, 18-24 months post treatment
Measured: 0-24 months
Assess impact of hybrid closed loop technology on glycemic control by analysis of sensor glucose data.
Compare sensor glucose data: 1) percent time in range (70-180 mg/dl), 2)percent time in auto-mode, 3) percent time sensor usage versus hemoglobin A1c data over time.
Measured: 0-24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start13 Jun 2018
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomedical TechnologyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Goodwin, Boston Children's Hospital
- Investigators
- Gregory Goodwin, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051632
- Sponsor's protocol ID
- IRB-P00028472
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)
- ClinicalTrials.gov ID
- NCT04051632
- Acronym / sponsor ID
- IRB-P00028472
- Conditions
- Biomedical Technology, Type 1 Diabetes
- Keywords
- Medtronic 670G
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 9 Aug 2019 (actual)
- 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.
Observational study of patients at Boston Childrens Hospital with type 1 diabetes (T1D) who elected to treat their diabetes with the Medtronic 670 G hybrid closed loop insulin pump.
Detailed description
Outcome study of 90-100 patients with type 1 diabetes who elected to use the Medtronic 670G.
Major outcome measure was to assess the percent of patients who were able to successfully continue to use the 670G technology over time.
Additional outcome variables included hemoglobin A1c pre and post treatment with the 670G, time in desired glucose range 70-180.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes patients treated with the Medtronic 670G | – | Device: Medtronic 670G insulin pumpType 1 Diabetes patients treated with the Medtronic 670G at Boston Childrens Hospital |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Single institution clinic population.
Key inclusion criteria (5 listed)
- clinical diagnosis of T1D
- patient of Boston Childrens Hospital diabetes program
- deemed to be adequate candidates for hybrid closed loop technology by their diabetes health care team
- patient received Medtronic 670G training at Boston Childrens Hospital
- patient received follow up diabetes care at Boston Childrens Hospital for at least 3 months after starting on the 670G
Key exclusion criteria (1 listed)
- patients not trained at Boston Childrens Hospital or self started
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 |
|---|---|---|
| Medtronic 670G insulin pump* percent of patients who continue to use Medtronic 670G over time * impact of 670G on glycemic control: hemoglobin A1c, time in range | Device | Type 1 Diabetes patients treated with the Medtronic 670G |
Primary outcome
Successful implementation of hybrid closed loop technology
Time frame: 0-24 months
Percent of Type 1 Diabetes patients who were properly trained on the use of the 670G that continue to use Hybrid Closed Loop technology at 0, 6, 12, 18 and 24 months post training.
2 secondary outcomes
Impact of hybrid closed loop technology on glycemic control
Time frame: 0-24 months
Assess impact of hybrid closed loop technology on glycemic control by analysis of sensor glucose data.
Time frame: 0-24 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 9 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Gregory Goodwin, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomedical Technology and Type 1 Diabetes, run by Boston Children's Hospital 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 5 inclusion and 1 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 9 Aug 2019. 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?
Successful implementation of hybrid closed loop technology (time frame: 0-24 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 9 Aug 2019.