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N/A Completed N=30

Continuous Glucose Monitor in Children With Poorly Controlled Diabetes

Source: ClinicalTrials.gov NCT02530450 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: The Primary Outcome Measure Was Change in HgbA1c — -0.95; -0.9; -0.6; -0.9 HbgA1c % — p=< 0.05

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
The Primary Outcome Measure Was Change in HgbA1c
-0.95; -0.9; -0.6; -0.9; -1.1; -0.5 < 0.05 sig
SECONDARY
% Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia
— —

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Medications known to affect glycemic control (oral steroids, growth hormone, psychotropics).
  • Documented concomitant chronic disease known to affect glycemic control.
  • 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.
  • 3 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02530450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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