Trial Outcomes & Findings for Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes (NCT NCT00315939)
NCT ID: NCT00315939
Last Updated: 2014-09-18
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
1 year (each level lasted 3 months)
Results posted on
2014-09-18
Participant Flow
A total of 120 adults with type 1 diabetes were recruited through regional advertising. Inclusion criteria were age ≥18 years, type 1 diabetes defined by the American Diabetes Association criteria or physician judgment, and willingness to participate in the study for up to 12 months performing finger sticks four to five times per day.
Participant milestones
| Measure |
Experimental: Group A Order: SMBG, IBMF-1, IBMF-2
Self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by Integrated Biobehavioral Monitoring \& Feedback - 1 (IBMF-1) level 2 and IBMF-2, level 3. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
|
Experimental: Group B Order: IBMF-1, IBMF-2, SMBG
Integrated Biobehavioral Monitoring \& Feedback - 1 (IBMF-1) level 2 followed by IBMF-2, level 3 and then SMBG only. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
|
|---|---|---|
|
Admission 1 (3 Months)
STARTED
|
59
|
61
|
|
Admission 1 (3 Months)
COMPLETED
|
56
|
55
|
|
Admission 1 (3 Months)
NOT COMPLETED
|
3
|
6
|
|
Admission 2 (3 Months)
STARTED
|
56
|
55
|
|
Admission 2 (3 Months)
COMPLETED
|
52
|
51
|
|
Admission 2 (3 Months)
NOT COMPLETED
|
4
|
4
|
|
Admission 3 (3 Months)
STARTED
|
52
|
51
|
|
Admission 3 (3 Months)
COMPLETED
|
48
|
49
|
|
Admission 3 (3 Months)
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Experimental: Group A Order: SMBG, IBMF-1, IBMF-2
n=59 Participants
Group A will perform routine SMBG alone (level 1), followed sequentially by levels 2 and 3. Each level continued for 3 months.
|
Experimental: Group B Order: IBMF-1, IBMF-2, SMBG
n=61 Participants
Group B will begin with level 2, followed by level 3 and then level 1. Each level will continue for 3 months.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.65 years
STANDARD_DEVIATION 14.84 • n=93 Participants
|
37.61 years
STANDARD_DEVIATION 13.78 • n=4 Participants
|
39.15 years
STANDARD_DEVIATION 14.35 • n=27 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 year (each level lasted 3 months)Population: All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using "dropout" as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown.
Outcome measures
| Measure |
Experimental Groups A and B
n=97 Participants
Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.
Each level continued for 3 months.
IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.
IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
|
|---|---|
|
Hemoglobin A1c
Baseline
|
7.99 percentage of glycated hemoglobin
Standard Deviation 1.48
|
|
Hemoglobin A1c
Post-Level 1
|
7.69 percentage of glycated hemoglobin
Standard Deviation 1.30
|
|
Hemoglobin A1c
Post-Level 2
|
7.69 percentage of glycated hemoglobin
Standard Deviation 1.33
|
|
Hemoglobin A1c
Post-Level 3
|
7.58 percentage of glycated hemoglobin
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: 1 year (each level lasted 3 months)Population: All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using "dropout" as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown.
Severe hypoglycemia (SH) was defined to subjects as "blood glucose so low that you could not treat yourself because you were stuporous or unconscious."
Outcome measures
| Measure |
Experimental Groups A and B
n=97 Participants
Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.
Each level continued for 3 months.
IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.
IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
|
|---|---|
|
Frequency of Severe Hypoglycemia
SH Baseline
|
0.09 episodes/month/person
|
|
Frequency of Severe Hypoglycemia
SH Post-Level 1
|
0.21 episodes/month/person
|
|
Frequency of Severe Hypoglycemia
SH Post-Level 2
|
0.15 episodes/month/person
|
|
Frequency of Severe Hypoglycemia
SH Post-Level 3
|
0.02 episodes/month/person
|
Adverse Events
IBMF-1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IBMF-2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place