Type 1 Diabetes Mellitus
Conditions
Keywords
Continuous Glucose Monitor, Adherence, Adolescents, Diabetes Education
Brief summary
The purpose of this research study is to find out ways to help pre-teens and teens and their families to improve diabetes control and to help with the burden of diabetes management. Specifically, the study aims to find out if coming to diabetes clinic more frequently and for a longer period of time helps adolescents with diabetes, and if adolescents who wear a continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.
Detailed description
Good glycemic control is critical in preventing chronic complications of type 1 diabetes. However, achieving good glycemic control remains elusive for many adolescents. This study evaluates two clinic-based approaches for improving glycemic control in adolescents with poorly controlled type 1 diabetes - an intensive diabetes support and education program alone and the same intensive diabetes support and education program together with continuous glucose monitoring - in comparison with standard diabetes care.
Interventions
BEHAVIORALDiabetes related psychological counseling and education
The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
DEVICEContinuous Glucose Monitor
Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
Sponsors
National Institute of Mental Health (NIMH)
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus of at least 12 months duration, followed by Rainbow Babies and Children's Pediatric Endocrinology and Diabetes Division * Most recent HbA1c \>= 8.5% * Patients must be willing to check their blood sugar at least 4 times daily while wearing the CGM * Patients and families must be willing to come to diabetes clinic once a month for 4 months
Exclusion criteria
* Inability to understand and/or speak the English language * Pregnancy * Psychological counseling with Dr. Rebecca Hazen regarding diabetes adherence prior to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control | Baseline and visit 4 | Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Dose Changes | Baseline and visit 4 | Insulin doses in units per kilogram per day will be calculated at baseline and visit 4. |
| Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL) | Total from baseline to visit 4 | CGM downloads at baseline and visit 4 will be used to tabulate the number of episodes of blood glucoses \< 70 mg/dL. At each visit patients will be asked to recall any episodes of severe hypoglycemia that occurred since the last visit. Data from the continuous glucose monitors will be used to evaluate the percent of time that patients are below 70 mg/dL and the number of glucose excursions below 70 mg/dL. Total number of excursions under 70 mg/dL from baseline to visit 4 will be added together. |
| Adherence to Prescribed Diabetes Regimen | Baseline and visit 4 | Diabetes Self Management Profile, given to participant (child) at baseline and visit 4. Minimum score zero, maximum score 88. A higher score indicates better adherence. The DSMP is a 10-15 minute, 25-question, validated, structured interview of adherence with diabetes self-management tasks administered separately to parents and youth. It was verbally administered by one pediatric endocrinologist and one trained research assistant. It assesses self-management of exercise and hypoglycemia (7 questions), carbohydrate counting and insulin dose calculation (6 questions), blood glucose and ketone monitoring (8 questions), and insulin timing and dosing (4 questions). |
| Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor | Visit 4 | Survey of patient and parent satisfaction in the interventions groups only, satisfaction with the overall study including CGM use and psychological intervention. Satisfaction measured on a 7 point Likert scale, with highest satisfaction at a score of 7 and lowest score 1. |
| Diabetes Knowledge | Baseline and month 4 | The Diabetes Knowledge Questionnaire was adapted from Butler et al. It is a written questionnaire, self administered independently to parents and children to assess their knowledge about diabetes management. It includes 37 multiple choice questions assessing basic information about diabetes, how to deal with diabetes-related tasks, and management of hypothetical situations. A total score out of 37 possible points is computed for diabetes knowledge, score can range from 0-37. A higher score indicates higher knowledge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Diabetes Care Patients will attend diabetes clinic as usual, once every 3 months. | 22 |
| Intensive Diabetes Clinic Patients will attend diabetes clinic on a monthly basis for 4 months in a row. Each patient will have a 30 minute visit with a physician, 30 minutes dedicated to diabetes education, and 45 minutes with a child psychologist.
Diabetes related psychological counseling and education: The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education. | 23 |
| Intensive Diabetes Clinic Plus CGM Patients in this group will include all procedures as listed for group 2 (intensive diabetes clinic) in addition to wearing a continuous glucose monitor for 3-5 days each month. Patients will also have an additional 30 minutes with a psychology graduate student dedicated to adherence with the CGM.
Diabetes related psychological counseling and education: The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
Continuous Glucose Monitor: Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months. | 23 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 1 |
| Overall Study | Pregnancy | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 5 | 3 |
Baseline characteristics
| Characteristic | Standard Diabetes Care | Total | Intensive Diabetes Clinic Plus CGM | Intensive Diabetes Clinic |
|---|---|---|---|---|
| Age, Continuous | 14.4 years STANDARD_DEVIATION 2.6 | 14.6 years STANDARD_DEVIATION 2.4 | 14.6 years STANDARD_DEVIATION 2.2 | 14.9 years STANDARD_DEVIATION 2.6 |
| HbA1c | 11.0 percent STANDARD_DEVIATION 2.2 | 10.3 percent STANDARD_DEVIATION 1.7 | 10.0 percent STANDARD_DEVIATION 1.4 | 9.9 percent STANDARD_DEVIATION 1.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 17 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 45 Participants | 16 Participants | 15 Participants |
| Sex: Female, Male Female | 14 Participants | 42 Participants | 15 Participants | 13 Participants |
| Sex: Female, Male Male | 8 Participants | 26 Participants | 8 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 1 / 22 | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 4 / 22 | 1 / 23 | 2 / 23 |
Outcome results
Primary
Glycemic Control
Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.
Time frame: Baseline and visit 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diabetes Care | Glycemic Control | VISIT 4 | 10.8 percent HbA1c | Standard Deviation 2.2 |
| Standard Diabetes Care | Glycemic Control | BASELINE | 11.0 percent HbA1c | Standard Deviation 2.1 |
| Intensive Diabetes Clinic | Glycemic Control | VISIT 4 | 9.43 percent HbA1c | Standard Deviation 1.1 |
| Intensive Diabetes Clinic | Glycemic Control | BASELINE | 9.93 percent HbA1c | Standard Deviation 1.3 |
| Intensive Diabetes Clinic Plus CGM | Glycemic Control | VISIT 4 | 9.4 percent HbA1c | Standard Deviation 0.9 |
| Intensive Diabetes Clinic Plus CGM | Glycemic Control | BASELINE | 10.0 percent HbA1c | Standard Deviation 1.4 |
Secondary
Adherence to Prescribed Diabetes Regimen
Diabetes Self Management Profile, given to participant (child) at baseline and visit 4. Minimum score zero, maximum score 88. A higher score indicates better adherence. The DSMP is a 10-15 minute, 25-question, validated, structured interview of adherence with diabetes self-management tasks administered separately to parents and youth. It was verbally administered by one pediatric endocrinologist and one trained research assistant. It assesses self-management of exercise and hypoglycemia (7 questions), carbohydrate counting and insulin dose calculation (6 questions), blood glucose and ketone monitoring (8 questions), and insulin timing and dosing (4 questions).
Time frame: Baseline and visit 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diabetes Care | Adherence to Prescribed Diabetes Regimen | VISIT 4 | 51 Score on a scale | Standard Deviation 12.4 |
| Standard Diabetes Care | Adherence to Prescribed Diabetes Regimen | BASELINE | 47.3 Score on a scale | Standard Deviation 10.6 |
| Intensive Diabetes Clinic | Adherence to Prescribed Diabetes Regimen | VISIT 4 | 58.0 Score on a scale | Standard Deviation 8.7 |
| Intensive Diabetes Clinic | Adherence to Prescribed Diabetes Regimen | BASELINE | 50.2 Score on a scale | Standard Deviation 11.2 |
| Intensive Diabetes Clinic Plus CGM | Adherence to Prescribed Diabetes Regimen | VISIT 4 | 54.9 Score on a scale | Standard Deviation 8.9 |
| Intensive Diabetes Clinic Plus CGM | Adherence to Prescribed Diabetes Regimen | BASELINE | 50.9 Score on a scale | Standard Deviation 9.8 |
Secondary
Diabetes Knowledge
The Diabetes Knowledge Questionnaire was adapted from Butler et al. It is a written questionnaire, self administered independently to parents and children to assess their knowledge about diabetes management. It includes 37 multiple choice questions assessing basic information about diabetes, how to deal with diabetes-related tasks, and management of hypothetical situations. A total score out of 37 possible points is computed for diabetes knowledge, score can range from 0-37. A higher score indicates higher knowledge.
Time frame: Baseline and month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diabetes Care | Diabetes Knowledge | Parents baseline knowledge | 33 score on a scale | Standard Deviation 3.3 |
| Standard Diabetes Care | Diabetes Knowledge | Parents visit 4 | 33 score on a scale | Standard Deviation 2.1 |
| Standard Diabetes Care | Diabetes Knowledge | Patients baseline | 27 score on a scale | Standard Deviation 5.9 |
| Standard Diabetes Care | Diabetes Knowledge | Patients visit 4 knowledge | 29 score on a scale | Standard Deviation 5.4 |
| Intensive Diabetes Clinic | Diabetes Knowledge | Patients visit 4 knowledge | 29 score on a scale | Standard Deviation 9.1 |
| Intensive Diabetes Clinic | Diabetes Knowledge | Parents baseline knowledge | 33 score on a scale | Standard Deviation 2 |
| Intensive Diabetes Clinic | Diabetes Knowledge | Patients baseline | 28 score on a scale | Standard Deviation 7.7 |
| Intensive Diabetes Clinic | Diabetes Knowledge | Parents visit 4 | 33 score on a scale | Standard Deviation 2.3 |
| Intensive Diabetes Clinic Plus CGM | Diabetes Knowledge | Patients visit 4 knowledge | 29 score on a scale | Standard Deviation 4.7 |
| Intensive Diabetes Clinic Plus CGM | Diabetes Knowledge | Parents visit 4 | 33 score on a scale | Standard Deviation 2.4 |
| Intensive Diabetes Clinic Plus CGM | Diabetes Knowledge | Patients baseline | 26 score on a scale | Standard Deviation 5.8 |
| Intensive Diabetes Clinic Plus CGM | Diabetes Knowledge | Parents baseline knowledge | 31 score on a scale | Standard Deviation 3.9 |
Secondary
Insulin Dose Changes
Insulin doses in units per kilogram per day will be calculated at baseline and visit 4.
Time frame: Baseline and visit 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diabetes Care | Insulin Dose Changes | VISIT 4 | 1.02 u/kg/day | Standard Deviation 0.3 |
| Standard Diabetes Care | Insulin Dose Changes | BASELINE | 0.98 u/kg/day | Standard Deviation 0.3 |
| Intensive Diabetes Clinic | Insulin Dose Changes | VISIT 4 | 1.03 u/kg/day | Standard Deviation 0.3 |
| Intensive Diabetes Clinic | Insulin Dose Changes | BASELINE | 1.09 u/kg/day | Standard Deviation 0.4 |
| Intensive Diabetes Clinic Plus CGM | Insulin Dose Changes | VISIT 4 | 1.10 u/kg/day | Standard Deviation 0.3 |
| Intensive Diabetes Clinic Plus CGM | Insulin Dose Changes | BASELINE | 1.0 u/kg/day | Standard Deviation 0.3 |
Secondary
Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)
CGM downloads at baseline and visit 4 will be used to tabulate the number of episodes of blood glucoses \< 70 mg/dL. At each visit patients will be asked to recall any episodes of severe hypoglycemia that occurred since the last visit. Data from the continuous glucose monitors will be used to evaluate the percent of time that patients are below 70 mg/dL and the number of glucose excursions below 70 mg/dL. Total number of excursions under 70 mg/dL from baseline to visit 4 will be added together.
Time frame: Total from baseline to visit 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diabetes Care | Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL) | Baseline | 3.3 number of hypoglycemic excursions | Standard Deviation 3.3 |
| Standard Diabetes Care | Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL) | Visit 4 | 2.9 number of hypoglycemic excursions | Standard Deviation 2 |
| Intensive Diabetes Clinic | Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL) | Baseline | 3.7 number of hypoglycemic excursions | Standard Deviation 3.3 |
| Intensive Diabetes Clinic | Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL) | Visit 4 | 4.4 number of hypoglycemic excursions | Standard Deviation 3.8 |
| Intensive Diabetes Clinic Plus CGM | Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL) | Baseline | 3.8 number of hypoglycemic excursions | Standard Deviation 3.8 |
| Intensive Diabetes Clinic Plus CGM | Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL) | Visit 4 | 4.0 number of hypoglycemic excursions | Standard Deviation 5.3 |
Secondary
Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor
Survey of patient and parent satisfaction in the interventions groups only, satisfaction with the overall study including CGM use and psychological intervention. Satisfaction measured on a 7 point Likert scale, with highest satisfaction at a score of 7 and lowest score 1.
Time frame: Visit 4
Population: Some parents did not fill out the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diabetes Care | Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor | Overall Patient Satisfaction | 6.3 score on a scale | Standard Deviation 0.8 |
| Standard Diabetes Care | Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor | Overall Parent Satisfaction | 6.1 score on a scale | Standard Deviation 1.1 |
| Intensive Diabetes Clinic | Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor | Overall Patient Satisfaction | 5.5 score on a scale | Standard Deviation 1.4 |
| Intensive Diabetes Clinic | Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor | Overall Parent Satisfaction | 6.6 score on a scale | Standard Deviation 0.6 |