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Improved Glycemic Control in Adult Subjects With Type 1 Diabetes on MDI Using Insulin Guidance Software

2015年8月10日 更新者:University of Colorado, Denver

Glycemic Control and Prevention of Hypoglycemia in Intensively Treated Subjects With Type 1 Diabetes Using Accu-Chek® Advisor Insulin Guidance Software

140 subjects will be enrolled into the clinical study and randomized into the Control Group or the Experimental Group by block randomization. The subjects must meet all inclusion and none of the exclusion criteria. Each subject will have 7 clinic visits and 3 phone visits. The Baseline Visit will consist of a complete history, vitals, a physical examination and completion of the consent and screening process. All clinic visits, except for the Baseline Visit will include meter/PDA download. In addition, meter education will be provided to all subjects, and PDA education will be provided to the Experimental group at the Baseline Visit and 2-Week Visit as needed to ensure subject understanding. The phone visits will consist of a history including any changes in insulin dose, and any hypoglycemic events, hyperglycemic events, or other adverse events that have occurred since the last clinic visit.

The primary endpoint in this study was to show a reduction in A1c of at least 0.4% or higher in the insulin guidance software group at 6 months and/or 1 year.

調査の概要

状態

完了

条件

詳細な説明

Research Design and Methods A total of 123 adult subjects with type 1 diabetes with a baseline A1c of 7.5-11% were enrolled in the study at the Barbara Davis Center for Childhood Diabetes at the University of Colorado at Denver Health Sciences Center. Two patients screen failed (entry criteria not met) before randomization, leaving 60 subjects randomized to the control group and 61 subjects randomized to the experimental group (Advisor). Subjects were randomized based on lottery system using sealed envelopes. All patients had baseline blood work which included a complete blood count (CBC), complete metabolic panel (CMP), creatnine kinase (CK) and an A1c. The mean A1c at baseline was 8.54 ±0.11 in the control group and 8.42 ±0.11 in the experimental group (p=0.4265).

Subjects were randomized on a 1:1 basis to either the experimental or control group. All subjects in the experimental group received the same training for insulin guidance software program for personal data assistant (PDA). All subjects were given a glucose meter and an unlimited supply of test strips for self monitoring of blood glucose (SMBG). Women who were pregnant or planning to become pregnant were excluded from participation in the study as were patients on insulin pumps, those taking glucocorticoid therapy, and those diagnosed with cancer, liver disease, anemia or hepatitis. Patients who exercised more than five days a week, or often traveled internationally were also excluded.

The protocol was approved by the Colorado Multiple Institutional Review Board (COMIRB). All subjects signed an informed consent form before being enrolled in the study.

Visits All subjects were asked to attend 7 in clinic visits (baseline, 2 week, 6 week, 3 month, 6 month, 9 month and 12 month) and participate in 3 telephone visits (4.5month, 7.5month, 9.5 month) throughout the course of the study. Data for blood glucose values, testing frequency, hyperglycemic excursions, hypoglycemic events (all, nocturnal, and severe), insulin dose, weight and BMI, hospitalizations, emergency room visits and illnesses were recorded at each in clinic visit. All subjects completed a patient satisfaction questionnaire and the experimental group also completed an Advisor questionnaire.

As part of their routine clinical care, any additional phone visits were equally encouraged in both groups.

Advisor Insulin Guidance Software (Figure 1a) Subjects randomized to the experimental group received a PDA loaded with the insulin guidance software. At baseline (visit 1), a healthcare provider and/or certified diabetes educator (CDE) reviewed the features of the software on the PDA and loaded a subject specific insulin dosing algorithm into the software based on the physician's recommendations. The software program allowed the healthcare provider to enter demographic data such as age, height and weight which could potentially affect the insulin sensitivity factor already programmed into the device. The program advised basal, bolus and correction insulin dosages based on individual patients' prescriptions in addition to being alerted for SMBG testing. Subjects in the experimental group were also asked to input their blood glucose values into the PDA via the touch screen. Subjects then received a recommended insulin dose based on their prescription which was programmed by the healthcare provider. The patients were asked to either agree with the recommended insulin dose or disagree, and manually enter the insulin dose they took for a given event. All the data from the glucose meters and the PDAs were downloaded at every visit.

Glucose Target Ranges Glucose values were captured in one of the following categories to assess target glycemia and pie charts were created. Within Target Range (WTR) glucose values were those between 70-150mg/dL (3.89 to 8.33 mmol/L) (20). Below Target Range (BTR) glucose values were defined as ≤ 69mg/dL (3.83 mmol/L) and Above Target Range (ATR) glucose values were those values above 150mg/dL (8.33 mmol/L). These glucose levels were chosen based on our previous research on SMBG downloads (20).

Hypoglycemia Hypoglycemia was defined as glucose values ≤ 59mg/dL (3.27mmol/L). Severe hypoglycemia was defined as subjects needing assistance as previously described by DCCT Research Group (1).

A1c and Other Lab Measurement

The A1c values were measured by the DCA 2000® Analyzer, distributed by Bayer Corporation (Elkhart, IN). The DCA 2000® A1c assay gives accurate and precise results over a range of total hemoglobin from 7 to 24 g/dL. All subjects had hemoglobin concentrations well within these values. Normal A1c values are 3.4 to 6.2 % (18). The CBC (Beckman Coulter LH750, Beckman Coulter, Hialeah, FL), CMP (AU-5200 Olympus Japan Co Ltd, Tokyo) and CK (Olympus AU-800; Olympus, Tokyo, Japan) were performed by Quest Diagnostics, Denver, Colorado.

Statistical Analysis Wilcoxon Rank Sum and Chi Square tests of independence were used to compare continuous and categorical variables, respectively, at baseline. Chi Square test of independence was used to compare the number of discontinued subjects between the two groups. Mixed model repeated measures analysis with an unstructured covariance structure and pre-planned contrasts were used to compare the experimental and control groups on A1c, percent of glucose readings within, above, and below target, percent of total hypoglycemic events, basal insulin dose, weight, and BMI. Paired t-tests were used to test the within group change in weight from baseline to 12 months among those who completed all 12 months. Fisher's Exact test was used to compare the number of patients achieving target values between groups at each time point. Poisson regression was used to compare the frequency of severe hypoglycemic events between the two groups. Data are presented as least squares mean ± SE unless otherwise noted. All analyses were performed using SAS 9.1. Results were considered significant at p < 0.05 using a two-sided alpha.

研究の種類

観察的

入学 (実際)

123

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Colorado
      • Aurora、Colorado、アメリカ、80045
        • University of Colorado Health Sciences Center, Barbara Davis Center for Diabetes

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~60年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

123 adult subjects ages 18-60 with type 1 diabetes on mulitiple daily injections

説明

Inclusion Criteria:

  • Adult male or female, 18 to 60 years of age
  • Diagnosed with Type 1 diabetes mellitus at least six months
  • HbA1c 7.5% and 11.0% at screening
  • Insulin dose 0.5 - 2.0 units/kg
  • Hematocrit between 25% and 65%
  • Weight 100-300 pounds
  • On a dual insulin therapy supported by Accu-Chek Insulin Advisor software
  • On a "day shift" schedule (typical day begins before noon)
  • Willing to perform a minimum of three blood glucose tests per day - before breakfast, before lunch, and before dinner (standard of care)
  • Willing to complete at least 7 clinic visits in 12 months (Baseline, 2-Week, 6-Week, 3-Month, 6-Month, 9-Month, and 12-Month)
  • Willing to complete 3 study phone calls conducted by study coordinator (4.5-month, 7.5-Month and 10.5-Month)
  • Able and willing to provide written informed consent to participate
  • Willing to comply with the study protocol
  • Willing to be randomized into either the Control Group or the Experimental Group

Exclusion Criteria:

  • On insulin pump therapy
  • On oral, inhaled or pre-mixed insulin
  • Engaged in a minimum of 30 minutes of cardiovascular (aerobic) exercise 5 days out of a 7-day week
  • Conditions that can cause significant increase of the insulin sensitivity factor, such as a steroid therapy, diabetic ketosis, insulin-resistant syndrome
  • Creatinine above 2.5mg/dl, renal transplantation or currently undergoing kidney dialysis
  • Pregnant or intends to become pregnant during the course of the study
  • Undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer
  • Plan to travel to a different time zone more than three times per month
  • Clinical signs or symptoms of liver disease such as jaundice
  • Diagnosis of acute or chronic hepatitis
  • Diagnosis of hemoglobinopathy or chronic anemia
  • Severe unexplained hypoglycemia in the past 3 months that required ED admission
  • Participation in another clinical trial in the past 1 month
  • Weight under 100 pounds or over 300 pounds

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Control
The other half of the patients were randomized to the control group who were followed for their routine diabetes care and had to visit the clinic on the same schedule as the experimental group.
At baseline a healthcare provider reviewed the features of the software on the PDA and loaded a subject specific insulin dosing algorithm into the software based on the physician's recommendations. The program advised basal, bolus and correction insulin dosages based on individual patients' prescriptions in addition to being alerted for SMBG testing. Subjects in the experimental group were also asked to input their blood glucose values into the PDA via the touch screen. Subjects then received a recommended insulin dose based on their prescription which was programmed by the healthcare provider. The patients were asked to either agree with the recommended insulin dose or disagree, and manually enter the insulin dose they took for a given event.
他の名前:
  • Accu-Chek Insulin Guidance Software
Experimental
Half of the subjects were randomized to this group using insulin guidance software on a PDA to adjust their insulin dose at home based on the prescription provided by the provider.
At baseline a healthcare provider reviewed the features of the software on the PDA and loaded a subject specific insulin dosing algorithm into the software based on the physician's recommendations. The program advised basal, bolus and correction insulin dosages based on individual patients' prescriptions in addition to being alerted for SMBG testing. Subjects in the experimental group were also asked to input their blood glucose values into the PDA via the touch screen. Subjects then received a recommended insulin dose based on their prescription which was programmed by the healthcare provider. The patients were asked to either agree with the recommended insulin dose or disagree, and manually enter the insulin dose they took for a given event.
他の名前:
  • Accu-Chek Insulin Guidance Software

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Decrease in A1c of at least 0.4% in the insulin guidance software group as compared to the control group at 6 months and/or 1 year.
時間枠:1 year
1 year

二次結果の測定

結果測定
時間枠
Hypoglycemic episodes, weight gain, insulin dose, frequency of self monitoring of glucose
時間枠:1 year
1 year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Satish K Garg, MD、University of Colorado, Denver

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2005年7月1日

研究の完了 (実際)

2007年5月1日

試験登録日

最初に提出

2007年10月31日

QC基準を満たした最初の提出物

2007年11月1日

最初の投稿 (見積もり)

2007年11月2日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年8月13日

QC基準を満たした最後の更新が送信されました

2015年8月10日

最終確認日

2015年8月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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