Trial Outcomes & Findings for The Guardcontrol Trial: Study to Assess if Type 1 Diabetics Can Improve Using the Real-time Values of Guardian RT (NCT NCT00111228)
NCT ID: NCT00111228
Last Updated: 2019-04-01
Results Overview
Hemoglobin A1c (HbA1c) - change from baseline to end of 3 month study period, calculated as A1c at 3 month - A1c at baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
162 participants
Primary outcome timeframe
baseline and 3 month after study
Results posted on
2019-04-01
Participant Flow
Participant milestones
| Measure |
Continuous Use of the Guardian RT
Continuous use of the Guardian RT group
Guardian RT
|
Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)
Bi-weekly use of the Guardian RT (once every 2 weeks) group
Guardian RT
|
Control Group. SMBG Monitoring
Control group. SMBG monitoring group
SMBG only: SMBG only
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
54
|
|
Overall Study
COMPLETED
|
49
|
53
|
54
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
0
|
Reasons for withdrawal
| Measure |
Continuous Use of the Guardian RT
Continuous use of the Guardian RT group
Guardian RT
|
Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)
Bi-weekly use of the Guardian RT (once every 2 weeks) group
Guardian RT
|
Control Group. SMBG Monitoring
Control group. SMBG monitoring group
SMBG only: SMBG only
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
0
|
Baseline Characteristics
The Guardcontrol Trial: Study to Assess if Type 1 Diabetics Can Improve Using the Real-time Values of Guardian RT
Baseline characteristics by cohort
| Measure |
Continuous Use of the Guardian RT
n=54 Participants
Continuous use of the Guardian RT group
Guardian RT
|
Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)
n=54 Participants
Bi-weekly use of the Guardian RT (once every 2 weeks) group
Guardian RT
|
Control Group. SMBG Monitoring
n=54 Participants
Control group. SMBG monitoring group
SMBG only: SMBG only
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.24 Years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
25.92 Years
STANDARD_DEVIATION 14.03 • n=7 Participants
|
27.42 Years
STANDARD_DEVIATION 16.53 • n=5 Participants
|
26.52 Years
STANDARD_DEVIATION 14.63 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 3 month after studyHemoglobin A1c (HbA1c) - change from baseline to end of 3 month study period, calculated as A1c at 3 month - A1c at baseline
Outcome measures
| Measure |
Continuous Use of the Guardian RT
n=54 Participants
Continuous use of the Guardian RT group
Guardian RT
|
Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)
n=54 Participants
Bi-weekly use of the Guardian RT (once every 2 weeks) group
Guardian RT
|
Control Group. SMBG Monitoring
n=54 Participants
Control group. SMBG monitoring group
SMBG only: SMBG only
|
|---|---|---|---|
|
Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period
|
-0.99 percentage of HbA1C
Standard Deviation 1.13
|
-0.70 percentage of HbA1C
Standard Deviation 1.27
|
-0.39 percentage of HbA1C
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: baseline and 3 month after studyAverage blood glucose - change from baseline to end of 3 month study period, calculated as average blood glucose at 3 month - average blood glucose at baseline
Outcome measures
| Measure |
Continuous Use of the Guardian RT
n=54 Participants
Continuous use of the Guardian RT group
Guardian RT
|
Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)
n=54 Participants
Bi-weekly use of the Guardian RT (once every 2 weeks) group
Guardian RT
|
Control Group. SMBG Monitoring
n=54 Participants
Control group. SMBG monitoring group
SMBG only: SMBG only
|
|---|---|---|---|
|
Average Blood Glucose - Change From Baseline to End of 3 Month Study Period, Calculated as Average Blood Glucose at 3 Month - Average Blood Glucose at Baseline
|
-12.38 mg/dL
Standard Deviation 44.18
|
-12.17 mg/dL
Standard Deviation 50.37
|
-2.21 mg/dL
Standard Deviation 45.10
|
Adverse Events
Continuous Use of the Guardian RT
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Control Group. SMBG Monitoring
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Continuous Use of the Guardian RT
n=54 participants at risk
Continuous use of the Guardian RT group
Guardian RT
|
Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)
n=54 participants at risk
Bi-weekly use of the Guardian RT (once every 2 weeks) group
Guardian RT
|
Control Group. SMBG Monitoring
n=54 participants at risk
Control group. SMBG monitoring group
SMBG only: SMBG only
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Ketoacidosis
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Pancreatits viral etiology
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Metabolism and nutrition disorders
Ketoacidosis in urinary infection
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Metabolism and nutrition disorders
SEVERE HYPOGLYCEMIA
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Acute viral gastroenteritis with DKA
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
Other adverse events
| Measure |
Continuous Use of the Guardian RT
n=54 participants at risk
Continuous use of the Guardian RT group
Guardian RT
|
Bi-weekly Use of the Guardian RT (Once Every 2 Weeks)
n=54 participants at risk
Bi-weekly use of the Guardian RT (once every 2 weeks) group
Guardian RT
|
Control Group. SMBG Monitoring
n=54 participants at risk
Control group. SMBG monitoring group
SMBG only: SMBG only
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Allergic reaction of the transmitter tape
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
General disorders
Bleeding when the 2nd sensor was inserted
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Catch a cold and get fever
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Injury, poisoning and procedural complications
CGMS sensor accidentally pulled out
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Fever due to viral syndrome
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Influence, fever, cough, chest pain
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Influenza
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
General disorders
Mild illness with fever
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
General disorders
Mild skin irritation under transmitter tape
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
General disorders
Pruritus and redness under the transmitter
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Skin and subcutaneous tissue disorders
Red lesion of toe
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
General disorders
Redness under the Guardian transmitter
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
General disorders
Redness, itching under the sticker for trasmitter
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Metabolism and nutrition disorders
Severe hypo glycemia
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Upper respiratory infection- viral
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
9.3%
5/54 • Number of events 6 • 3 month study period
|
|
Infections and infestations
Viral gastroenterocolitis
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
3.7%
2/54 • Number of events 2 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
|
Infections and infestations
Viral upper respiratory infection
|
3.7%
2/54 • Number of events 2 • 3 month study period
|
3.7%
2/54 • Number of events 2 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
General disorders
Minor bleeding at sensor insertion site
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Paronychia
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Recurrence of upper respiratory tract infection
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Rhinopharingitis and fever
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Injury, poisoning and procedural complications
Subperiostal fractute of distal left raduis
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Suppurative infection behind right ear (furunculus)
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Tonsilopharyngitis
|
0.00%
0/54 • 3 month study period
|
5.6%
3/54 • Number of events 3 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Urinary infection
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Viral Infection
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Viral rhinopharingitis
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
|
Infections and infestations
Otitis with major hyperglycemia for 6 days
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
|
Metabolism and nutrition disorders
Otitis with major hyperglycemia for 6 days
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
|
Infections and infestations
Stomach flu
|
0.00%
0/54 • 3 month study period
|
0.00%
0/54 • 3 month study period
|
1.9%
1/54 • Number of events 1 • 3 month study period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60