Ignite Creation Date:
2024-05-06 @ 12:28 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01580462
Status:
UNKNOWN
Last Update Posted:
2012-04-19
First Post:
2012-04-18
Brief Title:
The ADHERENCE Index - the Indicator of Effective Coping With the Requirements of the Disease of Children and Adolescents With Type 1 Diabetes
Sponsor:
Institute of Mother and Child Warsaw Poland
Organization:
Institute of Mother and Child Warsaw Poland
Study Overview
Official Title:
The ADHERENCE Index - the Indicator of Effective Coping With the Requirements of the Disease of Children and Adolescents With Type 1 Diabetes Prospective Study
Status:
UNKNOWN
Status Verified Date:
2012-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADHERENCE
Brief Summary:
The aim of the research is to develop a mathematical model called ADHERENCE index and to evaluate its effectiveness
Detailed Description:
For many years glycosylated hemoglobin A1C is one of the universal indicators of metabolic control in patients with diabetes The results of A1C levels reflect the average blood glucose levels from the period of three months A1C is one of the most important information for diabetes team it allows to determine the effects of treatment In the long-term analysis it is a predictor of the complication risk A1C value is affected by many factors the method of treatment type of insulin self-control numbers of hypoglycemia etc In the case of similar methods of treatment ability to cope with diabetes self-management ability of correct interpretation of glycemic values and adaptation of insulin doses appears to be the factor which determines A1C levels But there is still a lack of objective methods to assess effective coping with the requirements of the illness - adherence Currently it is based primarily on a subjective feeling of diabetes team
The aim of the research is to develop a mathematical model called ADHERENCE index and to evaluate its effectiveness
Methods
Participants
Participants will be recruited from the Outpatient Diabetes Clinic in the Institute of Mother and Child Patient should be treated by intensive insulinotherapy using Continuous Subcutaneous Infusion Set CSII Number of participants 200
Study plan - data collecting
Patients will attend diabetes clinic as usual with one additional visit in the middle of the 3-months period During those visits data from glucometers and insulin pumps will be downloaded
1 Visit 1 V0 - getting agreement to participate in the study giving information about the study collecting patients in initial interview HbA1c measurement by DCA Vantage Analyzer Siemens control the settings of time and date in insulin pumps and glucometers ask for using one kind of glucometer and if its impossible - to set time and date in every glucometer and to take them all for the next visits Setting terms of next visits after 6 1 and 12 2 weeks
2 Visit 2 V1 - after 6 1 weeks after V0 - downloading data from the insulin pump and glucometers by Diasend and CareLink software Collecting information about some accidents ketoacidosis severe hypoglycemia ketonuria illness treated with antibiotics Reminding about the next visit V2
3 Visit 3 V2 - after 6 1 weeks after V1 - the last visit downloading data from the insulin pump and glucometers by Diasend and CareLink software Collecting information about some accidents ketoacidosis severe hypoglycemia ketonuria illness treated with antibiotics the A1C measurement
After data collection they will be taken under analysis Downloaded data will be compared to A1C After that factors which are crucial for A1C will be found Last part of the research is an attempt to create a mathematical model
Data important for mathematical model
Downloaded
BG values - average standard deviation number of values per day values above goal 180 mgdl values within goal 70-180 mgdl values below goal 70 mgdl percentage of measurements fall within the recommended range 70-180 mgdl Low Blood Glucose Index LBGI and High Blood Glucose Index HBGI
Insulin pumps data - average total daily dose average daily basal average daily bolus percentage of daily basal and bolus doses number of boluses per day number of extended boluses per day using of temporary basal rate number of stoppings number of days with one infusion set
Collected by the interview
Number and time of ketoacidosis ketonuria severe hypoglycemia illness treated with antibiotics Interview during the V0 visit sex weight height age suffering from diabetes in age A1C level reported total daily dose type of insulin Humalog Novorapid Apidra number of places in body for infusion reported number of days with one infusion set place of residence village town city
Expected outcomes
Obtaining a mathematical model - an ADHERENCE index - will allow to assess an adherence to diabetes and self-management It will be an objective indicator which could allow to identify the most impacting factor which determines A1C levels and to identify this aspects of diabetes self- management which should be improved by diabetes education or motivation Using of ADHERENCE index should allow to identify patients with poor self-management earlier than it could be symbolized by high A1C level It could also allow to draw conclusions about the most important aspects of diabetes self-management
The aim of the research is to develop a mathematical model called ADHERENCE index and to evaluate its effectiveness
Methods
Participants
Participants will be recruited from the Outpatient Diabetes Clinic in the Institute of Mother and Child Patient should be treated by intensive insulinotherapy using Continuous Subcutaneous Infusion Set CSII Number of participants 200
Study plan - data collecting
Patients will attend diabetes clinic as usual with one additional visit in the middle of the 3-months period During those visits data from glucometers and insulin pumps will be downloaded
1 Visit 1 V0 - getting agreement to participate in the study giving information about the study collecting patients in initial interview HbA1c measurement by DCA Vantage Analyzer Siemens control the settings of time and date in insulin pumps and glucometers ask for using one kind of glucometer and if its impossible - to set time and date in every glucometer and to take them all for the next visits Setting terms of next visits after 6 1 and 12 2 weeks
2 Visit 2 V1 - after 6 1 weeks after V0 - downloading data from the insulin pump and glucometers by Diasend and CareLink software Collecting information about some accidents ketoacidosis severe hypoglycemia ketonuria illness treated with antibiotics Reminding about the next visit V2
3 Visit 3 V2 - after 6 1 weeks after V1 - the last visit downloading data from the insulin pump and glucometers by Diasend and CareLink software Collecting information about some accidents ketoacidosis severe hypoglycemia ketonuria illness treated with antibiotics the A1C measurement
After data collection they will be taken under analysis Downloaded data will be compared to A1C After that factors which are crucial for A1C will be found Last part of the research is an attempt to create a mathematical model
Data important for mathematical model
Downloaded
BG values - average standard deviation number of values per day values above goal 180 mgdl values within goal 70-180 mgdl values below goal 70 mgdl percentage of measurements fall within the recommended range 70-180 mgdl Low Blood Glucose Index LBGI and High Blood Glucose Index HBGI
Insulin pumps data - average total daily dose average daily basal average daily bolus percentage of daily basal and bolus doses number of boluses per day number of extended boluses per day using of temporary basal rate number of stoppings number of days with one infusion set
Collected by the interview
Number and time of ketoacidosis ketonuria severe hypoglycemia illness treated with antibiotics Interview during the V0 visit sex weight height age suffering from diabetes in age A1C level reported total daily dose type of insulin Humalog Novorapid Apidra number of places in body for infusion reported number of days with one infusion set place of residence village town city
Expected outcomes
Obtaining a mathematical model - an ADHERENCE index - will allow to assess an adherence to diabetes and self-management It will be an objective indicator which could allow to identify the most impacting factor which determines A1C levels and to identify this aspects of diabetes self- management which should be improved by diabetes education or motivation Using of ADHERENCE index should allow to identify patients with poor self-management earlier than it could be symbolized by high A1C level It could also allow to draw conclusions about the most important aspects of diabetes self-management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None