Type 1 Diabetes MellitusNCT01104142
Efficacy of Continuous Glucose Monitoring in Subjects With Type 1 Diabetes Mellitus on Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) Therapy
An observational study of Type 1 Diabetes Mellitus, run by DexCom, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of the Continuous Glucose Monitoring System (DexCom™ SEVEN PLUS®) and to evaluate the impact of CGM on glycemic control when worn for up to 6-months by subjects 18 to 70 years-old with Type 1 diabetes mellitus on MDI or CSII therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- CGM
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This clinical study population will consist of a minimum of 100, and up to 120 subjects with insulin-requiring diabetes mellitus on Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) therapy; equal number of subjects will be enrolled among each therapy group. It is desirable to have a similar distribution of baseline A1C in each study group.
Who may be able to join
- Age 18 to 70 years;
- Have been diagnosed with Type 1 diabetes at least 3 years;
- Have been treated on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy for at last 6 months;
- Willing not to switch method of insulin delivery (i.e., MDI to CSII, or CSII to MDI) while enrolled in this study;
- Baseline A1C within 6.5% to 10.0% (may be determined by POC measurement, e.g., DCA 2000 to assess this inclusion criterion);
- Patients on MDI should be on a stable dose of peak-less insulin (e.g., Lantus) once or twice a day along with any rapid acting prandial insulin analog (e.g., Humalog, Novolog, or Apidra);
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- Willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the Sensor site during Sensor wear;
- Willing to use only the blood glucose meter(s) provided to them for self-monitoring of blood glucose (SMBG) during Sensor wear;
- Willing to take a minimum of 4 fingersticks per day during home use (2 for calibration purposes, 2 for comparative purposes);
- Willing to refrain from the use of acetaminophen during the Sensor insertion period and for at least 24-hours prior to Sensor insertion;
- Willing not to schedule a magnetic resonance (MRI) scan, computed tomography (CT) scan, or x-ray, for the duration of the study;
- Able to speak, read, and write English.
Who cannot join
- 1. Have extensive skin changes/diseases that preclude wearing the Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites; 2. Subjects who have a known allergy to medical-grade adhesives; 3. Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion or are planning to become pregnant during the course of study; 4. Have a hematocrit that is less than 30%, or greater than 55%; 5. Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study); 6. Have used CGM for 6 or more weeks (combined) during the 3 months prior to enrollment; 7. Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C).
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
About this study
The purpose of this study is to evaluate the effectiveness of the Continuous Glucose Monitoring System (DexCom™ SEVEN PLUS®) and to evaluate the impact of CGM on glycemic control when worn for up to 6-months by subjects 18 to 70 years-old with Type 1 diabetes mellitus on MDI or CSII therapy.
The primary objective of this study is to demonstrate no statistically significant differences between MDI and CSII subjects in terms of A1C change at 6 months as compared to baseline. A secondary objective is to evaluate time spent outside of the euglycemic region (70 to 180 mg/dL) from the baseline (blinded month) to the conclusion of 6 month follow-up.
Safety data of the SEVEN PLUS System will also be collected and safety will be characterized by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects experienced by study participants.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- 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.
CGMDevice
Continuous Glucose Monitoring System
| Study group | Role | What they receive |
|---|---|---|
| MDI | Subject on multiple Daily Injections Receives: Device: CGM | |
| CSII | Subjects on Continuous Subcutaneous Insulin Infusion Receives: Device: CGM |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew K Balo, Study chair, DexCom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104142
- Sponsor's protocol ID
- PTL-900222
- Status last verified
- Apr 2010
- First submitted
- 13 Apr 2010
- Last updated
- 15 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Garg SK, Voelmle MK, Beatson CR, Miller HA, Crew LB, Freson BJ, Hazenfield RM. Use of continuous glucose monitoring in subjects with type 1 diabetes on multiple daily injections versus continuous subcutaneous insulin infusion therapy: a prospective 6-month study. Diabetes Care. 2011 Mar;34(3):574-9. doi: 10.2337/dc10-1852. Epub 2011 Jan 28.
PubMed 21278138
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Continuous Glucose Monitoring in Subjects With Type 1 Diabetes Mellitus on Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) Therapy
- ClinicalTrials.gov ID
- NCT01104142
- Acronym / sponsor ID
- PTL-900222
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- First posted
- 15 Apr 2010 (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.
The purpose of this study is to evaluate the effectiveness of the Continuous Glucose Monitoring System (DexCom™ SEVEN PLUS®) and to evaluate the impact of CGM on glycemic control when worn for up to 6-months by subjects 18 to 70 years-old with Type 1 diabetes mellitus on MDI or CSII therapy.
The primary objective of this study is to demonstrate no statistically significant differences between MDI and CSII subjects in terms of A1C change at 6 months as compared to baseline. A secondary objective is to evaluate time spent outside of the euglycemic region (70 to 180 mg/dL) from the baseline (blinded month) to the conclusion of 6 month follow-up.
Safety data of the SEVEN PLUS System will also be collected and safety will be characterized by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects experienced by study participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDI | – | Device: CGMSubject on multiple Daily Injections |
| CSII | – | Device: CGMSubjects on Continuous Subcutaneous Insulin Infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical study population will consist of a minimum of 100, and up to 120 subjects with insulin-requiring diabetes mellitus on Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) therapy; equal number of subjects will be enrolled among each therapy group. It is desirable to have a similar distribution of baseline A1C in each study group.
Key inclusion criteria (12 listed)
- Age 18 to 70 years;
- Have been diagnosed with Type 1 diabetes at least 3 years;
- Have been treated on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy for at last 6 months;
- Willing not to switch method of insulin delivery (i.e., MDI to CSII, or CSII to MDI) while enrolled in this study;
- Baseline A1C within 6.5% to 10.0% (may be determined by POC measurement, e.g., DCA 2000 to assess this inclusion criterion);
Key exclusion criteria (1 listed)
- 1. Have extensive skin changes/diseases that preclude wearing the Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites; 2. Subjects who have a known allergy to medical-grade adhesives; 3. Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion or are planning to become pregnant during the course of study; 4. Have a hematocrit that is less than 30%, or greater than 55%; 5. Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study); 6. Have used CGM for 6 or more weeks (combined) during the 3 months prior to enrollment; 7. Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C).
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 |
|---|---|---|
| CGMContinuous Glucose Monitoring System | Device | CSII, MDI |
Primary outcome
Not reported in the source record.
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 15 Apr 2010.
- Derived from this study: PubMed 21278138Garg SK, Voelmle MK, Beatson CR, Miller HA, Crew LB, Freson BJ, Hazenfield RM. Use of continuous glucose monitoring in subjects with type 1 diabetes on multiple daily injections versus continuous subcutaneous insulin infusion therapy: a prospective 6-month study. Diabetes Care. 2011 Mar;34(3):574-9. doi: 10.2337/dc10-1852. Epub 2011 Jan 28.
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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.
Andrew K Balo study chair
DexCom, Inc.
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 Type 1 Diabetes Mellitus, run by DexCom, Inc. 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 12 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 15 Apr 2010. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01104142, which also lists 1 linked publication.
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 15 Apr 2010.