Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Adolescents, Glucose Monitoring
Brief summary
The purpose of this study is to determine that continuous glucose monitoring systems (CGMS) with intensive real time feedback about diabetes management from medical staff to the patient will affect motivation and/or behavior, in adolescents with poorly controlled type 1 diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack thereof) and patients' sense of self-efficacy will influence their stage of change and potentially glucose levels.
Detailed description
Sixty adolescents, ages 13-19 years, with type 1 diabetes and an HbA1c \> = 8 % who are also naive to CGMS use will be recruited from the diabetes outpatient population followed at Bellevue Hospital, Lutheran Hospital, Woodhull Hospital, and the NYU Fink Pediatric Ambulatory Care Center. Forty subjects will be randomly assigned to the CGMS group and 20 subjects will be assigned to the control group.
Interventions
DEVICECGMS Device
OTHERNo Device
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* type 1 diabetes * HbA1c \> = 8 % * naive to CGMS use
Exclusion criteria
* Patients with developmental delay * Patients who do not use a glucose meter to test capillary blood glucose level * Patients without access to a telephone will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months | Baseline, 3 Months | The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months. |
| Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months | Baseline, 3 Months | HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change. |
| Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months | Baseline, 3 Months | Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline. |
| Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months | Baseline, 3 months | There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glucose Meter Continuing Glucose Monitoring Device
CGMS Device | 9 |
| No Glucose Meter Average Blood glucose measure
No Device | 3 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Glucose Meter | No Glucose Meter | Total |
|---|---|---|---|
| Age, Continuous | 16 years | 17 years | 16 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 9 participants | 3 participants | 12 participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 3 |
| other Total, other adverse events | 0 / 9 | 0 / 3 |
| serious Total, serious adverse events | 0 / 9 | 0 / 3 |
Outcome results
Primary
Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months
HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change.
Time frame: Baseline, 3 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Glucose Meter | Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months | -9.4 mmol/mol |
| No Glucose Meter | Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months | -36 mmol/mol |
Primary
Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months
Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline.
Time frame: Baseline, 3 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Glucose Meter | Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months | -0.1 mg/dl |
| No Glucose Meter | Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months | 0 mg/dl |
Primary
Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months
There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Glucose Meter | Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months | 0.375 units on a scale |
| No Glucose Meter | Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months | -0.25 units on a scale |
Primary
Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months
The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.
Time frame: Baseline, 3 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Glucose Meter | Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months | 6.4 score on a scale |
| No Glucose Meter | Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months | -3.8 score on a scale |