Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diabetes related psychological counseling and education

Continuous Glucose Monitor

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Continuous Glucose Monitor, Adherence, Adolescents, Diabetes Education

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UHCMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Standard Diabetes Care

Intensive Diabetes Clinic

Intensive Diabetes Clinic plus CGM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Glycemic Control

Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.

Secondary Outcome Measures

Insulin Dose Changes

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)

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

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

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

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.

Full Information

NCT ID

NCT01083433

First Posted

March 8, 2010

Last Updated

January 3, 2022

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01083433

Brief Title

Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes

Official Title

Intensive Diabetes Clinic and Intermittent Continuous Glucose Monitoring in Adolescents With Type 1 Diabetes Mellitus in Poor Glycemic Control

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospitals Cleveland Medical Center

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

Continuous Glucose Monitor, Adherence, Adolescents, Diabetes Education

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Diabetes Care

Arm Type

No Intervention

Arm Description

Patients will attend diabetes clinic as usual, once every 3 months.

Arm Title

Intensive Diabetes Clinic

Arm Type

Experimental

Arm Description

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.

Arm Title

Intensive Diabetes Clinic plus CGM

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Diabetes related psychological counseling and education

Other Intervention Name(s)

Diabetes Education, Diabetes Psychological Counseling

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Continuous Glucose Monitor

Other Intervention Name(s)

Medtronic Minimed iPro

Intervention Description

Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.

Primary Outcome Measure Information:

Title

Glycemic Control

Description

Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.

Time Frame

Baseline and visit 4

Secondary Outcome Measure Information:

Title

Insulin Dose Changes

Description

Insulin doses in units per kilogram per day will be calculated at baseline and visit 4.

Time Frame

Baseline and visit 4

Title

Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)

Description

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

Title

Adherence to Prescribed Diabetes Regimen

Description

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

Title

Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor

Description

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

Title

Diabetes Knowledge

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah A MacLeish, D.O.

Organizational Affiliation

UHCMC Division of Pediatric Endocrinology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rebecca A Hazen, Ph.D.

Organizational Affiliation

UHCMC Division of Behavioral Pediatrics

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leona Cuttler, M.D

Organizational Affiliation

UHCMC Division of Pediatric Endocrinology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rose Gubitosi-Klug, M.D, Ph.D.

Organizational Affiliation

UHCMC Division of Pediatric Endocrinology

Official's Role

Principal Investigator

Facility Information:

Facility Name

UHCMC

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8366922

Citation

Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

Results Reference

background

PubMed Identifier

16609090

Citation

Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7. doi: 10.1001/jama.295.14.1681.

Results Reference

background

PubMed Identifier

18227477

Citation

Monnier L, Colette C. Glycemic variability: should we and can we prevent it? Diabetes Care. 2008 Feb;31 Suppl 2:S150-4. doi: 10.2337/dc08-s241.

Results Reference

background

PubMed Identifier

19821754

Citation

Weber C, Schnell O. The assessment of glycemic variability and its impact on diabetes-related complications: an overview. Diabetes Technol Ther. 2009 Oct;11(10):623-33. doi: 10.1089/dia.2009.0043.

Results Reference

background

PubMed Identifier

18809715

Citation

El-Osta A, Brasacchio D, Yao D, Pocai A, Jones PL, Roeder RG, Cooper ME, Brownlee M. Transient high glucose causes persistent epigenetic changes and altered gene expression during subsequent normoglycemia. J Exp Med. 2008 Sep 29;205(10):2409-17. doi: 10.1084/jem.20081188. Epub 2008 Sep 22. Erratum In: J Exp Med. 2008 Oct 27;205(11):2683.

Results Reference

background

PubMed Identifier

16241882

Citation

Hirsch IB. Glycemic variability: it's not just about A1C anymore! Diabetes Technol Ther. 2005 Oct;7(5):780-3. doi: 10.1089/dia.2005.7.780. No abstract available.

Results Reference

background

PubMed Identifier

19885298

Citation

Monnier L, Colette C, Owens DR. Glycemic variability: the third component of the dysglycemia in diabetes. Is it important? How to measure it? J Diabetes Sci Technol. 2008 Nov;2(6):1094-100. doi: 10.1177/193229680800200618.

Results Reference

background

PubMed Identifier

17130215

Citation

Deiss D, Bolinder J, Riveline JP, Battelino T, Bosi E, Tubiana-Rufi N, Kerr D, Phillip M. Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006 Dec;29(12):2730-2. doi: 10.2337/dc06-1134. No abstract available.

Results Reference

background

PubMed Identifier

14707890

Citation

Schaepelynck-Belicar P, Vague P, Simonin G, Lassmann-Vague V. Improved metabolic control in diabetic adolescents using the continuous glucose monitoring system (CGMS). Diabetes Metab. 2003 Dec;29(6):608-12. doi: 10.1016/s1262-3636(07)70076-9.

Results Reference

background

PubMed Identifier

18779236

Citation

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.

Results Reference

background

Type 1 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial