An interventional study of Diabetes related psychological counseling and education and Continuous Glucose Monitor in Type 1 Diabetes Mellitus, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-01-13.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment
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.
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 68 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University Hospitals Cleveland Medical Center is the lead sponsor of 293 studies on the registry; 43 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 30 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will attend diabetes clinic as usual, once every 3 months.
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.
Behavioral: Diabetes related psychological counseling and education
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.
Behavioral: Diabetes related psychological counseling and education · Device: Continuous Glucose Monitor
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.
Also known as: Diabetes Education, Diabetes Psychological Counseling
Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
Also known as: Medtronic Minimed iPro
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
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
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
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
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
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
| Milestone | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM |
|---|---|---|---|
| Started | 22 | 23 | 23 |
| Completed | 20 | 17 | 18 |
| Not completed | 2 | 6 | 5 |
| Withdrew: Lost to follow-up | 2 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 5 | 3 |
| Withdrew: Pregnancy | 0 | 0 | 1 |
Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.
| percent HbA1c | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM |
|---|---|---|---|
| VISIT 4 | 10.8 ± 2.2 | 9.43 ± 1.1 | 9.4 ± 0.9 |
| BASELINE | 11.0 ± 2.1 | 9.93 ± 1.3 | 10.0 ± 1.4 |
Insulin doses in units per kilogram per day will be calculated at baseline and visit 4.
| u/kg/day | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM |
|---|---|---|---|
| VISIT 4 | 1.02 ± 0.3 | 1.03 ± 0.3 | 1.10 ± 0.3 |
| BASELINE | 0.98 ± 0.3 | 1.09 ± 0.4 | 1.0 ± 0.3 |
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.
| number of hypoglycemic excursions | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM |
|---|---|---|---|
| Baseline | 3.3 ± 3.3 | 3.7 ± 3.3 | 3.8 ± 3.8 |
| Visit 4 | 2.9 ± 2.0 | 4.4 ± 3.8 | 4.0 ± 5.3 |
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).
| Score on a scale | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM |
|---|---|---|---|
| VISIT 4 | 51 ± 12.4 | 58.0 ± 8.7 | 54.9 ± 8.9 |
| BASELINE | 47.3 ± 10.6 | 50.2 ± 11.2 | 50.9 ± 9.8 |
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.
| score on a scale | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM |
|---|---|---|
| Overall Patient Satisfaction | 6.3 ± 0.8 | 5.5 ± 1.4 |
| Overall Parent Satisfaction | 6.1 ± 1.1 | 6.6 ± 0.6 |
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.
| score on a scale | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM |
|---|---|---|---|
| Parents baseline knowledge | 33 ± 3.3 | 33 ± 2.0 | 31 ± 3.9 |
| Parents visit 4 | 33 ± 2.1 | 33 ± 2.3 | 33 ± 2.4 |
| Patients baseline | 27 ± 5.9 | 28 ± 7.7 | 26 ± 5.8 |
| Patients visit 4 knowledge | 29 ± 5.4 | 29 ± 9.1 | 29 ± 4.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Diabetes Care | 0/22 (0%) | 4/22 (18.2%) | 1/22 (4.5%) |
| Intensive Diabetes Clinic | 0/23 (0%) | 1/23 (4.3%) | 0/23 (0%) |
| Intensive Diabetes Clinic Plus CGM | 0/23 (0%) | 2/23 (8.7%) | 0/23 (0%) |
| Event | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM |
|---|---|---|---|
| Diabetic KetoacidosisEndocrine disorders | 4/22 | 1/23 | 2/23 |
| Event | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM |
|---|---|---|---|
| Continuous Glucose Monitor Site InfectionInfections and infestations | 1/22 | 0/23 | 0/23 |
| Age, Continuous(years) | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM | Total |
|---|---|---|---|---|
| Mean | 14.4 ± 2.6 | 14.9 ± 2.6 | 14.6 ± 2.2 | 14.6 ± 2.4 |
| Sex: Female, Male(Participants) | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM | Total |
|---|---|---|---|---|
| Female | 14 | 13 | 15 | 42 |
| Male | 8 | 10 | 8 | 26 |
| Race (NIH/OMB)(Participants) | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 5 | 6 | 17 |
| White | 14 | 15 | 16 | 45 |
| More than one race | 2 | 3 | 1 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| HbA1c(percent) | Standard Diabetes Care | Intensive Diabetes Clinic | Intensive Diabetes Clinic Plus CGM | Total |
|---|---|---|---|---|
| Mean | 11.0 ± 2.2 | 9.9 ± 1.3 | 10.0 ± 1.4 | 10.3 ± 1.7 |
The record gives a start of May 2010, a primary completion of Sep 2011 and a completion of Oct 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2022, 10 years 4 months after primary completion.
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