ABSTRACT
OBJECTIVE: The objective of this study was to evaluate the safety and efficacy of home pramlintide use in adolescents with type 1 diabetes. PATIENTS AND METHODS: This was a randomized, 28-day pilot trial of pramlintide (maximum dose: 30 microg per meal) in 10 adolescents aged 13 to 17 years. End points included changes in hemoglobin A1c (HbA1c) values, body weight, and postprandial peak blood glucose levels and area under the curve on continuous glucose monitoring. RESULTS: Changes in HbA1c values, body weight, and total insulin dose declined in the treatment group compared with the control group (bootstrapped, P Subject(s)
Amyloid/therapeutic use
, Diabetes Mellitus, Type 1/drug therapy
, Hypoglycemic Agents/therapeutic use
, Adolescent
, Area Under Curve
, Blood Glucose/analysis
, Body Weight
, Diabetes Mellitus, Type 1/blood
, Female
, Glycated Hemoglobin/analysis
, Humans
, Hyperglycemia/prevention & control
, Insulin Infusion Systems
, Islet Amyloid Polypeptide
, Male
, Postprandial Period
ABSTRACT
OBJECTIVE: To determine if use of an injection port, the Insuflon, would help to improve glycemic control in youth with type 1 diabetes (TID) who were in suboptimal glycemic control (hemoglobin A1c, HbA1c >8.0%). STUDY DESIGN: A three-arm randomized protocol was used to study the effects of the Insuflon (a subcutaneous injection port) vs. an alarmable blood glucose meter vs. a control group on glycemic control in 66 youth with T1D. All participants used insulin glargine as their basal insulin and the NovoPen Junior with insulin aspart as their rapid-acting insulin. Participants were randomized into control, alarm, or Insuflon groups. HbA1c levels were the primary outcome with values at baseline, 3, and 6 months. RESULTS: Initial parameters were similar in the three groups. HbA1c values were significantly lower for youth who used the Insuflon than for the control group at 3 and 6 months (p = 0.025). The HbA1c values (in %) for youth using the Insuflon decreased significantly from 9.4 at screening to 8.7 at 3 months (p < 0.001) and 8.5 at 6 months (p < 0.001). There were no significant reductions (p > or = 0.05) in the HbA1c values within the other two groups. CONCLUSION: The Insuflon injection port helps some youth with T1D to improve glycemic control.
Subject(s)
Blood Glucose Self-Monitoring , Diabetes Mellitus, Type 1/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Insulin/analogs & derivatives , Adolescent , Blood Glucose , Catheters, Indwelling , Child , Female , Glycated Hemoglobin/analysis , Humans , Insulin/administration & dosage , Insulin Aspart , Insulin Glargine , Insulin, Long-Acting , MaleABSTRACT
BACKGROUND: The purpose of this study was to evaluate the effectiveness of directly integrating self-monitoring blood glucose (BG) information with insulin pump therapy on overall glycemic control. METHODS: In this randomized trial, 34 youth with type 1 diabetes using insulin pump therapy were trained on the use of the Deltec Cozmo Insulin Pump. Seventeen were randomized to use the CoZmonitor Blood Glucose Module, a device that attaches to the back of the pump using FreeStyle technology to perform BG tests which read directly on the pump screen. The remaining 17 (control group) used a FreeStyle Flash meter, a stand-alone BG meter, for their BG testing. At baseline, 3 and 6 months, the subjects filled out a questionnaire, had a hemoglobin A1c (HbA1c) test, and had pumps and meters downloaded. RESULTS: After 3 months of study, there were no changes in mean HbA1c (+/- SD) values for the experimental (8.7 +/- 1.1 to 8.6 +/- 1.1) or the control groups (9.1 +/- 1.4 to 9.2 +/- 1.5). There were also no significant differences in HbA1c values after 6 months. The average number of BG tests per day did not change significantly in either group during the study. After 3 and 6 months, the experimental group rated satisfaction with the use of the CoZmonitor at 4.4 and 3.8 (respectively) on a five-point Likert scale, with 5 being the most satisfied. CONCLUSIONS: Although significant changes in HbA1c values or the number of BG tests were not found, use of the BG module had a positive level of satisfaction.
