Phase 3
N=451
Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00406133 ↗Enrolled (actual)
451
Serious AEs
7.3%
Results posted
Sep 2009
Primary outcome: Primary: Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort) — -0.37; -0.22; -0.18; -0.21 Percent — p=0.29
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Continuous glucose monitor (Device)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort) |
-0.37; -0.22; -0.18; -0.21; -0.50; 0.02 | 0.29 |
| PRIMARY Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%) |
54; 91 | 0.16 |
| SECONDARY Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) |
4; 6; 3; 5; 5; 4 | 0.74 |
| SECONDARY Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) |
646; 710; 750; 746; 691; 697 | 0.53 |
| SECONDARY Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) |
745; 671; 643; 635; 650; 641 | 0.58 |
| SECONDARY Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort |
343; 282; 242; 268; 271; 265 | 0.18 |
| SECONDARY Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) |
49; 59; 47; 59; 99; 102 | 0.29 |
| SECONDARY Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) |
17; 18; 10; 13; 37; 42 | 0.50 |
| SECONDARY Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) |
0.84; 0.83; 0.82; 0.83; 0.85; 0.86 | 0.66 |
| SECONDARY Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c <7.0% Cohort) |
0.02; 0.33 | <0.001 sig |
| SECONDARY Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%) |
1063; 949 | <0.001 sig |
| SECONDARY Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%) |
283; 341 | 0.03 sig |
| SECONDARY Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort |
48; 82 | 0.005 sig |
| SECONDARY Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%) |
4; 8 | 0.05 |
| SECONDARY Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%) |
0.66; 0.66 | 0.39 |
| SECONDARY Quality of Life |
33.3; 36.0 | 0.04 sig |
| SECONDARY Cost-effectiveness of CGM. |
70904; 49438 | — |
| SECONDARY QALW |
23.23; 21.84 | — |
| SECONDARY Total Costs: Direct and Indirect Costs |
31675; 20764 | — |
Summary
Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0% in 3 age groups (>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring (CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A parallel randomized trial is being conducted for a second cohort with HbA1c =7.0%.
The >=7.0% trial was specifically designed and statistically powered to compare separately the impact of continuous versus standard intensive glucose monitoring in the three age groups. Both trials used standardized treatment algorithms and equivalent frequent contacts with subjects in both the CGM and control group.
After completion of the 26-week trial, the CGM group continues to use CGM for another 26 weeks to evaluate whether any beneficial effect seen in the first 6 months is sustained with longer-term use and less intensive contact and the control group initiates CGM use with less intensive contact after the first month than was provided at initiation of CGM use in the CGM group in the randomized trial.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age >8 years
- Glycated hemoglobin(HbA1c) 7.0%-10.0% for the primary cohort and 9 years old and primary care giver (i.e., parent or guardian if subject is a minor) comprehend written English or Spanish
- This requirement is due to the fact that the questionnaires to be used as outcome measures do not have validated versions in other languages.
- Spanish-speaking subjects will be enrolled only if a RT-CGM device that functions in Spanish and has a User Guide in Spanish is available.
- No expectation that subject will be moving out of the area of the clinical center during the next year, unless the move will be to an area served by another study center.
- Informed Consent Form signed by the subject (or parent/guardian if subject is a minor, with subject signing the Child Assent Form)
Exclusion Criteria
- The presence of a significant medical disorder or use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
- The presence of any of the following diseases:
- Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
- Cystic fibrosis
- Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
- Inpatient psychiatric treatment in the past 6 months (if the subject is a minor, for either the subject or the subject's primary care giver).
- Home use of RT-CGM in past 6 months
- Use of a CGMS or GlucoWatch does not exclude subjects from enrollment
- Participation in an intervention study (including psychological studies) in past 6 weeks.
- Another member of the same household is participating in this study.
- For females, pregnant or intending to become pregnant during the next year Pregnancy is an exclusion because of uncertainty about the lag between interstitial fluid glucose and blood glucose during pregnancy, which might affect the accuracy of the sensor. Subjects who become pregnant during the study will be discontinued from the study.
Data sourced from ClinicalTrials.gov (NCT00406133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.