Continuous Glucose Monitor in Children With Poorly Controlled Diabetes

NCT02530450 | Completed Results

• 1 other identifier: HSC20110049H
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if the use of continuous glucose monitoring in a practical outpatient clinic setting in children with poorly controlled diabetes will lead to improved blood sugar control.

Conditions

Type 1 Diabetes Mellitus

Keywords

children; poor adherence; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure Was Change in HgbA1c

  0 months, 3 months and 6 months

Secondary Outcomes (1)

• % Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia

  3 months and 6 months

Study Arms (2)

Group 1

Initially blinded to continuous glucose monitoring (CGM) data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use

Device: continuous glucose monitoring (CGM)

Group 2

Never blinded to continuous glucose monitoring (CGM) data

Device: continuous glucose monitoring (CGM)

Interventions

continuous glucose monitoring (CGM) DEVICE

All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.

Also known as: iPRO

Group 1; Group 2

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are pediatric, with a clinical diagnosis of diabetes for at least 6 months, who have been treated in the diabetic clinic for at least 3 months previously.

You may qualify if:

• Clinical diagnosis of diabetes for at least 6 months, type 1 or type 2 diabetes.
• Treated at UT Health Science Center pediatric diabetes clinic for at least the previous 3 months.
• HgbA1c \>8.5% (equivalent to average BG of \>205 mg/dL for past three months).
• Supportive family with willingness to self monitoring blood glucose values at least 4 times per day during study.
• Supportive family with willingness to participate in continuous glucose monitoring (CGM) for at least 48 hours including self monitoring blood glucose values at least 4 times per day, documenting meals, carbohydrates eaten, insulin dose given, exercise, and hypoglycemic symptoms.
• Attend proposed clinic, nutritional, and CGM follow up visits.
• Pump or multiple daily injection (MDI) insulin therapy (3-4 injections minimum daily). If on pump, on pump for at least the past 3 months. Current insulin regimen involves basal/ bolus therapy with no plans to switch the modality of insulin administration during the study (e.g., injection user switching to a pump, pump user switching to injections).
• Hypoglycemic unawareness.
• English or Spanish primary language.

You may not qualify if:

• Medications known to affect glycemic control (oral steroids, growth hormone, psychotropics).
• Documented concomitant chronic disease known to affect glycemic control.
• or more incidents in the last 12 months of severe hypoglycemia with documented blood glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalization or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
• or more incidents in the last 12 months of diabetic ketoacidosis (DKA).
• Reported alcohol or drug abuse.
• Documented cutaneous allergy to latex products.
• Documented eating disorders or morbid obesity as assessed by the investigator.
• Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
• Home use of CGM in the past 6 months.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Medtronic Diabetes: collaborator

Related Publications (18)

• Maahs DM, West NA, Lawrence JM, Mayer-Davis EJ. Epidemiology of type 1 diabetes. Endocrinol Metab Clin North Am. 2010 Sep;39(3):481-97. doi: 10.1016/j.ecl.2010.05.011.

  PMID: 20723815 BACKGROUND

• 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: 8366922 BACKGROUND

• Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.

  PMID: 16371630 BACKGROUND

• Borus JS, Laffel L. Adherence challenges in the management of type 1 diabetes in adolescents: prevention and intervention. Curr Opin Pediatr. 2010 Aug;22(4):405-11. doi: 10.1097/MOP.0b013e32833a46a7.

  PMID: 20489639 BACKGROUND

• Boland E, Monsod T, Delucia M, Brandt CA, Fernando S, Tamborlane WV. Limitations of conventional methods of self-monitoring of blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1858-62. doi: 10.2337/diacare.24.11.1858.

  PMID: 11679447 BACKGROUND

• Gandrud LM, Xing D, Kollman C, Block JM, Kunselman B, Wilson DM, Buckingham BA. The Medtronic Minimed Gold continuous glucose monitoring system: an effective means to discover hypo- and hyperglycemia in children under 7 years of age. Diabetes Technol Ther. 2007 Aug;9(4):307-16. doi: 10.1089/dia.2007.0026.

  PMID: 17705686 BACKGROUND

• Bode BW, Gross TM, Thornton KR, Mastrototaro JJ. Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. Diabetes Res Clin Pract. 1999 Dec;46(3):183-90. doi: 10.1016/s0168-8227(99)00113-8.

  PMID: 10624783 BACKGROUND

• Tanenberg R, Bode B, Lane W, Levetan C, Mestman J, Harmel AP, Tobian J, Gross T, Mastrototaro J. Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: a randomized controlled trial. Mayo Clin Proc. 2004 Dec;79(12):1521-6. doi: 10.4065/79.12.1521.

  PMID: 15595336 BACKGROUND

• Chetty VT, Almulla A, Odueyungbo A, Thabane L. The effect of continuous subcutaneous glucose monitoring (CGMS) versus intermittent whole blood finger-stick glucose monitoring (SBGM) on hemoglobin A1c (HBA1c) levels in Type I diabetic patients: a systematic review. Diabetes Res Clin Pract. 2008 Jul;81(1):79-87. doi: 10.1016/j.diabres.2008.02.014. Epub 2008 Apr 15.

  PMID: 18417243 BACKGROUND

• Kaufman FR, Gibson LC, Halvorson M, Carpenter S, Fisher LK, Pitukcheewanont P. A pilot study of the continuous glucose monitoring system: clinical decisions and glycemic control after its use in pediatric type 1 diabetic subjects. Diabetes Care. 2001 Dec;24(12):2030-4. doi: 10.2337/diacare.24.12.2030.

  PMID: 11723078 BACKGROUND

• Ludvigsson J, Hanas R. Continuous subcutaneous glucose monitoring improved metabolic control in pediatric patients with type 1 diabetes: a controlled crossover study. Pediatrics. 2003 May;111(5 Pt 1):933-8. doi: 10.1542/peds.111.5.933.

  PMID: 12728068 BACKGROUND

• Lagarde WH, Barrows FP, Davenport ML, Kang M, Guess HA, Calikoglu AS. Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial. Pediatr Diabetes. 2006 Jun;7(3):159-64. doi: 10.1111/j.1399-543X.2006.00162.x.

  PMID: 16787523 BACKGROUND

• 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: 14707890 BACKGROUND

• Ryan EA, Germsheid J. Use of continuous glucose monitoring system in the management of severe hypoglycemia. Diabetes Technol Ther. 2009 Oct;11(10):635-9. doi: 10.1089/dia.2009.0042.

  PMID: 19821755 BACKGROUND

• Hood KK, Rohan JM, Peterson CM, Drotar D. Interventions with adherence-promoting components in pediatric type 1 diabetes: meta-analysis of their impact on glycemic control. Diabetes Care. 2010 Jul;33(7):1658-64. doi: 10.2337/dc09-2268.

  PMID: 20587726 RESULT

• Stanger C, Ryan SR, Delhey LM, Thrailkill K, Li Z, Li Z, Budney AJ. A multicomponent motivational intervention to improve adherence among adolescents with poorly controlled type 1 diabetes: a pilot study. J Pediatr Psychol. 2013 Jul;38(6):629-37. doi: 10.1093/jpepsy/jst032. Epub 2013 May 22.

  PMID: 23699750 RESULT

• Mulvaney SA, Hood KK, Schlundt DG, Osborn CY, Johnson KB, Rothman RL, Wallston KA. Development and initial validation of the barriers to diabetes adherence measure for adolescents. Diabetes Res Clin Pract. 2011 Oct;94(1):77-83. doi: 10.1016/j.diabres.2011.06.010. Epub 2011 Jul 7.

  PMID: 21737172 RESULT

• Telo GH, Volkening LK, Butler DA, Laffel LM. Salient characteristics of youth with type 1 diabetes initiating continuous glucose monitoring. Diabetes Technol Ther. 2015 Jun;17(6):373-8. doi: 10.1089/dia.2014.0290. Epub 2015 Mar 6.

  PMID: 25749206 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Dr. Maria Rayas, Assistant Professor in Pediatric Endocrinology and Diabetes
• Organization: UT Health Science Center in San Antonio

rayas@uthscsa.edu

210-567-5283

Study Officials

• Maria Rayas, MD

  UT Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 21, 2015
• Study Start: May 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 6, 2017
• Results First Posted: January 23, 2017

Record last verified: 2017-09