Type 1 Diabetes MellitusNCT02813421
Continue Glucose Monitoring Before Insulin Pump
A study testing CGM Informed in people with Type 1 Diabetes Mellitus, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The purpose of the study is to learn more about blood glucose control when people with Type 1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to stable blood glucoses and less frequent insulin… Read more about this study
- Who is it for?
- Ages 2 to 24 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- CGM Informed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 1 May 2017
- 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 2 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and Females aged 2-24 years
- Clinical diagnosis of Type 1 diabetes mellitus
- Duration of diabetes: At least 6 months
- This will ensure some glycemic stability prior to study, and most children do not start on an insulin pump until about 6 months into their diagnosis.
- Basal/bolus insulin regimen using long-acting and rapid-acting insulin
- This will provide a uniform method of insulin therapy.
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- Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2
- Willingness to wear the iPro®2 for 5 days continuously per insertion
- Participant agrees to comply with the study protocol requirements
- Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights signed by the participant and/or parent guardian
Who cannot join
- Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control
- Glucocorticoid use within 2 weeks of study enrollment
- Concurrent use of other medications that may affect glycemic control
- Prior CGM use in the past 6 months
- The participant has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of iPro®2 placement that has not been resolved at the time of enrollment and would inhibit the participant from wearing the iPro®2.
- Non-English or non-Spanish speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy
The purpose of the study is to learn more about blood glucose control when people with Type 1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to stable blood glucoses and less frequent insulin pump dose changes during the transition to an insulin pump.
Read the detailed description
This is a prospective, randomized controlled study. Participants will be asked to wear a Medtronic iPro2 continuous glucose monitor (CGM) 1-2 weeks prior to starting on insulin pump therapy. Depending on randomization groups, participants will either have CGM data used inform starting insulin pump doses (treatment group), or to standard of care for starting on insulin pump (control group). Participants will wear the CGM again during the first 5 days of pump start and at approximately 6 weeks after pump start, in order to collect blood glucose data. Each time the CGM is worn, blood glucoses must be checked 6-8 times daily, and a written log must be completed. Baseline medical information also will be collected at the start of participation. Participants will also be asked to complete a questionnaire at approximately 6 weeks after pump start. Participation in the study will be complete after a standard of care follow up visit approximately 3 months after pump start.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- CGM Informed
- Keywords
- CGM
- 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.
CGM InformedDevice
Also called iPro2 Professional Continuous Glucose Monitor
| Study group | Role | What they receive |
|---|---|---|
| CGM Informed | Experimental | CGM data was available for use when determining starting insulin pump doses. Receives: Device: CGM Informed |
| Control | No intervention | CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)
Measured: First 6 weeks of insulin pump therapy
Secondary outcomes (12)
Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)
Measured: First 5 days of insulin pump therapy
Mean Blood Glucose (mg/dL)
Other measures of glycemic variability obtained by iPro2 download
Measured: First 6 weeks of insulin pump therapy
Percentage Time Hyperglycemic
Data obtained by iPro2 download
Measured: First 6 weeks of insulin pump therapy
Total Daily Insulin Dose (Units)
Will be obtained by insulin pump download.
Measured: First 6 weeks of insulin pump therapy
Percentage Basal Insulin (%)
Will be obtained by insulin pump download.
Measured: First 6 weeks of insulin pump therapy
Total Number of Insulin Dose Adjustments
This data will be collected on standardized log sheets.
Measured: First 6 weeks of insulin pump therapy
Total Number of Phone Calls to Clinic Hotline
This data will be collected on standardized log sheets.
Measured: First 6 weeks of insulin pump therapy
Number of Insulin Dose Adjustments Made Per Phone Call
This data will be collected on standardized log sheets.
Measured: First 6 weeks of insulin pump therapy
Episodes of DKA
Measured: First 6 weeks of insulin pump therapy
Total Number of Episodes of Severe Hypoglycemia
Measured: First 6 weeks of insulin pump therapy
Hemoglobin A1c (%)
Difference in HbA1c from baseline to 3 months post-pump start
Measured: Baseline to 3 months post-pump start
Number of Participants With Satisfaction of Transition to Pump Therapy
6 question survey addressing patient/parent impressions of the process of transitioning to insulin pump therapy.
Measured: At 6 weeks after start of insulin pump therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startMar 2016
- Primary completion1 May 2017
- Study completion1 May 2017
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Ferris, MD, Children's Hospital Los Angeles
- Investigators
- Jessica A Ferris, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813421
- Sponsor's protocol ID
- CHLA-15-00535
- Status last verified
- May 2021
- First submitted
- 2 Jun 2016
- Last updated
- 25 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy
- ClinicalTrials.gov ID
- NCT02813421
- Acronym / sponsor ID
- CHLA-15-00535
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- CGM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to learn more about blood glucose control when people with Type 1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to stable blood glucoses and less frequent insulin pump dose changes during the transition to an insulin pump.
Detailed description
This is a prospective, randomized controlled study. Participants will be asked to wear a Medtronic iPro2 continuous glucose monitor (CGM) 1-2 weeks prior to starting on insulin pump therapy. Depending on randomization groups, participants will either have CGM data used inform starting insulin pump doses (treatment group), or to standard of care for starting on insulin pump (control group). Participants will wear the CGM again during the first 5 days of pump start and at approximately 6 weeks after pump start, in order to collect blood glucose data. Each time the CGM is worn, blood glucoses must be checked 6-8 times daily, and a written log must be completed. Baseline medical information also will be collected at the start of participation. Participants will also be asked to complete a questionnaire at approximately 6 weeks after pump start. Participation in the study will be complete after a standard of care follow up visit approximately 3 months after pump start.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM Informed | Experimental | Device: CGM InformedCGM data was available for use when determining starting insulin pump doses. |
| Control | No intervention | –CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care. |
Who may qualify
- Ages
- 2 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Males and Females aged 2-24 years
- Clinical diagnosis of Type 1 diabetes mellitus
- Duration of diabetes: At least 6 months
- Basal/bolus insulin regimen using long-acting and rapid-acting insulin
- Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2
Key exclusion criteria (6 listed)
- Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control
- Glucocorticoid use within 2 weeks of study enrollment
- Concurrent use of other medications that may affect glycemic control
- Prior CGM use in the past 6 months
- The participant has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of iPro®2 placement that has not been resolved at the time of enrollment and would inhibit the participant from wearing the iPro®2.
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 |
|---|---|---|
| CGM InformedAlso: iPro2 Professional Continuous Glucose Monitor | Device | CGM Informed |
Primary outcome
Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)
Time frame: First 6 weeks of insulin pump therapy
12 secondary outcomes
Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)
Time frame: First 5 days of insulin pump therapy
Mean Blood Glucose (mg/dL)
Time frame: First 6 weeks of insulin pump therapy
Percentage Time Hyperglycemic
Time frame: First 6 weeks of insulin pump therapy
Total Daily Insulin Dose (Units)
Time frame: First 6 weeks of insulin pump therapy
Percentage Basal Insulin (%)
Time frame: First 6 weeks of insulin pump therapy
Total Number of Insulin Dose Adjustments
Time frame: First 6 weeks of insulin pump therapy
Total Number of Phone Calls to Clinic Hotline
Time frame: First 6 weeks of insulin pump therapy
Number of Insulin Dose Adjustments Made Per Phone Call
Time frame: First 6 weeks of insulin pump therapy
Episodes of DKA
Time frame: First 6 weeks of insulin pump therapy
Total Number of Episodes of Severe Hypoglycemia
Time frame: First 6 weeks of insulin pump therapy
Hemoglobin A1c (%)
Time frame: Baseline to 3 months post-pump start
Number of Participants With Satisfaction of Transition to Pump Therapy
Time frame: At 6 weeks after start of insulin pump therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jessica A Ferris, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM Informed in people with Type 1 Diabetes Mellitus, run by Children's Hospital Los Angeles 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 10 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 25 May 2021. 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?
Yes. Results are posted in the registry (first posted 25 May 2021). 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?
Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL) (time frame: First 6 weeks of insulin pump therapy). 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 25 May 2021.