NCT01083433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
10.3 years until next milestone

Results Posted

Study results publicly available

January 13, 2022

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

March 8, 2010

Results QC Date

December 3, 2015

Last Update Submit

January 3, 2022

Conditions

Type 1 Diabetes Mellitus

Keywords

Continuous Glucose MonitorAdherenceAdolescentsDiabetes Education

Outcome Measures

Primary Outcomes (1)

  • Glycemic Control

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

    Baseline and visit 4

Secondary Outcomes (5)

  • Insulin Dose Changes

    Baseline and visit 4

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

    Total from baseline to visit 4

  • Adherence to Prescribed Diabetes Regimen

    Baseline and visit 4

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

    Visit 4

  • Diabetes Knowledge

    Baseline and month 4

Study Arms (3)

Standard Diabetes Care

NO INTERVENTION

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

Intensive Diabetes Clinic

EXPERIMENTAL

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

Intensive Diabetes Clinic plus CGM

EXPERIMENTAL

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 educationDevice: Continuous Glucose Monitor

Interventions

Diabetes related psychological counseling and educationBEHAVIORAL

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
Intensive Diabetes ClinicIntensive Diabetes Clinic plus CGM
Continuous Glucose MonitorDEVICE

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
Intensive Diabetes Clinic plus CGM

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to understand and/or speak the English language
  • Pregnancy
  • Psychological counseling with Dr. Rebecca Hazen regarding diabetes adherence prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHCMC

Cleveland, Ohio, 44106, United States

Location

Related Publications (10)

  • 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.

    PMID: 8366922BACKGROUND

  • 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.

    PMID: 16609090BACKGROUND

  • 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.

    PMID: 18227477BACKGROUND

  • 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.

    PMID: 19821754BACKGROUND

  • 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.

    PMID: 18809715BACKGROUND

  • 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.

    PMID: 16241882BACKGROUND

  • 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.

    PMID: 19885298BACKGROUND

  • 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.

    PMID: 17130215BACKGROUND

  • 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.

    PMID: 14707890BACKGROUND

  • 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.

    PMID: 18779236BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Limitations and Caveats

* High rate of attrition and lack of outcome data in patients lost to follow-up. * Lack of CGM alone group

Results Point of Contact

Title
Sarah A. MacLeish, DO
Organization
Rainbow Babies and Children's Hospital
sarah.macleish2@uhhospitals.org
216-844-3661

Study Officials

  • Sarah A MacLeish, D.O.

    UHCMC Division of Pediatric Endocrinology

    PRINCIPAL INVESTIGATOR

  • Rebecca A Hazen, Ph.D.

    UHCMC Division of Behavioral Pediatrics

    PRINCIPAL INVESTIGATOR

  • Leona Cuttler, M.D

    UHCMC Division of Pediatric Endocrinology

    PRINCIPAL INVESTIGATOR

  • Rose Gubitosi-Klug, M.D, Ph.D.

    UHCMC Division of Pediatric Endocrinology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 9, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

January 13, 2022

Results First Posted

January 13, 2022

Record last verified: 2022-01

Locations

US(1)