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Continuous Glucose Monitor in Children With Poorly Controlled Diabetes

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ClinicalTrials.gov Identifier: NCT02530450
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : January 23, 2017
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
Medtronic Diabetes
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Device: continuous glucose monitoring (CGM)

Detailed Description:

The trial was designed as a six month, randomized, prospective, interventional pilot study of children with uncontrolled (HgbA1c > 8.5%) diabetes who were between the ages of 7-17 years of age. The purpose of the study was to determine the effect in glycemic control as measured by HgbA1c with use of iPro™ CGM at regularly scheduled clinic appointments. Recruitment for this study was limited to patients at the University of Texas Health Science Center in San Antonio Pediatric Diabetes Clinic from May 2011 to March 2013. Subjects were randomized into Group1 or Group 2 using sequentially numbered, opaque sealed envelopes (SNOSE).

All subjects had point-of-care HgbA1c (standard of care) and CGM data collected at time points 0, 3 months, and 6 months. After a regularly scheduled clinic appointment, all subjects and families at time 0 were counseled by a registered dietician regarding carbohydrate counting with a focus on minimizing errors in carbohydrate estimation, as is standard of care for patients with poorly controlled diabetes in our clinic. At time 0, subjects in both Group 1 and 2 had CGM placement after meeting with the dietician. Group 1 subjects were blinded to the first CGM data, meaning that they did not review the CGM download data. Group 2 was scheduled to return to clinic within 2 weeks of placement to meet with a pediatric endocrinologist involved in the study to interpret the CGM results and make adjustments to insulin regimen if appropriate. Both Groups 1 and 2 were not blinded to CGM data at 3 months and 6 months. Again, the CGM was placed after their regularly scheduled diabetes clinic appointments and all families returned within 2 weeks of these visits to meet with the pediatric endocrinologist to interpret the data and adjust the insulin regimen if necessary.

The iPro™ CGM was worn for a minimum of 48 hours (2 days), maximum 96 hours (4 days). Participants were instructed to complete a minimum of 4 SMBG records daily while wearing the iPro™ CGM for system calibration purposes. Subjects documented SMBGs, meal times, carbohydrate intake, insulin doses, exercise, and any hypoglycemic symptoms in a log book for correlation to CGM data.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: iPro Continuous Glucose Monitor in Children With Poorly Controlled Diabetes: A 6-Month, Randomized, Interventional Pilot Study
Study Start Date : May 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
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)
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.
Other Name: iPRO

Group 2
Never blinded to continuous glucose monitoring (CGM) data
Device: continuous glucose monitoring (CGM)
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.
Other Name: iPRO




Primary Outcome Measures :
  1. The Primary Outcome Measure Was Change in HgbA1c [ Time Frame: 0 months, 3 months and 6 months ]

Secondary Outcome Measures :
  1. % Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia [ Time Frame: 3 months and 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of diabetes for at least 6 months, type 1 or type 2 diabetes.
  2. Treated at UT Health Science Center pediatric diabetes clinic for at least the previous 3 months.
  3. HgbA1c >8.5% (equivalent to average BG of >205 mg/dL for past three months).
  4. Supportive family with willingness to self monitoring blood glucose values at least 4 times per day during study.
  5. 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.
  6. Attend proposed clinic, nutritional, and CGM follow up visits.
  7. 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).
  8. Hypoglycemic unawareness.
  9. English or Spanish primary language.

Exclusion Criteria:

  1. Medications known to affect glycemic control (oral steroids, growth hormone, psychotropics).
  2. Documented concomitant chronic disease known to affect glycemic control.
  3. 3 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.
  4. 3 or more incidents in the last 12 months of diabetic ketoacidosis (DKA).
  5. Reported alcohol or drug abuse.
  6. Documented cutaneous allergy to latex products.
  7. Documented eating disorders or morbid obesity as assessed by the investigator.
  8. 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.
  9. Home use of CGM in the past 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530450


Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Medtronic Diabetes
Investigators
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Principal Investigator: Maria Rayas, MD UT Health Science Center San Antonio
Publications of Results:
Other Publications:

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02530450    
Other Study ID Numbers: HSC20110049H
First Posted: August 21, 2015    Key Record Dates
Results First Posted: January 23, 2017
Last Update Posted: October 6, 2017
Last Verified: September 2017
Keywords provided by The University of Texas Health Science Center at San Antonio:
children
poor adherence
continuous glucose monitoring
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases