Diabetes MellitusPhase 1NCT00207207
Self Monitoring of Blood Glucose With Finger Tip vs. Alternate Site Sampling: Effect on Long Term Glycemic Control
A Phase 1 study testing Alternate site blood glucose testing in people with Diabetes Mellitus, run by Boston Medical Center at 1 site in United States.
Trial summary
The objective is to assess the effect of using ASBG (alternate site blood glucose) versus FTBG (finger tip blood glucose) testing on long-term glycemic control in diabetics. Since ASBG measurements appear to lag behind FSBG measurements at times of changing glucose concentration, it is possible that ASBG measurements… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Alternate site blood glucose testing
- Type of treatment
- Surgery or procedure
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Oct 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria will include adults 18 -70 years of age with type II diabetes currently using insulin and recording SMBG measurements.
Who cannot join
- Patients will be excluded who have a history of hypoglycemic episodes, within the last two years, requiring urgent medical attention, hypoglycemia resulting in cognitive impairment, a lack of symptoms during hypoglycemic episodes. Subjects will also be excluded who have type I DM as determined by the investigators on a case-by-case basis, subjects who already utilize ASBG measurements or who have serious co-morbid illness (unstable cardiovascular disease, metastatic CA). Pregnant patients will also be excluded because of the more intense diabetic control they require.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Randomized Trial to Assess the Effect of Using Alternate Site Blood Glucose Testing Versus Finger-Tip Testing on Long-Term Glycemic Control.
The objective is to assess the effect of using ASBG (alternate site blood glucose) versus FTBG (finger tip blood glucose) testing on long-term glycemic control in diabetics. Since ASBG measurements appear to lag behind FSBG measurements at times of changing glucose concentration, it is possible that ASBG measurements will yield lower postprandial readings than FTBG, potentially causing a negative impact on long-term control. It is also possible that since ASBG is reportedly more comfortable than FTBG testing, it's use might improve adherence to testing and improve long term control.
Read the detailed description
Patients undergo an initial screening visit. Inclusion criteria include adults 18 -70 years of age with type II diabetes currently using insulin and recording SMBG measurements. Exclusion criteria include history of severe hypoglycemic episodes, current use of ASBG measurements, serious co-morbid illness or pregnancy. For eligible subjects baseline data including HbA1C is obtained. The goal for enrollment is 176 subjects. Subjects are randomized into either a fingertip or an arm-testing group within strata of baseline HbA1C. Each subject who does not already have one receives a One Touch Ultra® SMBG device. All subjects receive training in the use of this device, but for those in the arm-testing group this includes training on obtaining samples from the forearm. Arm- testing subjects are encouraged to use arm testing as much as possible but to use finger testing if they are not able to obtain a sample from the arm. All subjects are asked to perform SMBG testing before breakfast, before dinner and 2 hours after dinner and to complete diaries of all SMBG readings. At 1, 3 and 5 months after the training visit subjects see a diabetes provider who makes adjustments in the therapeutic regimen based on the SMBG measurements, as they would during routine diabetes management. Diary sheets are then collected and the data they contain is entered into a database. At months 2, 4 and 7 subjects present for a visit to drop off their diary sheets. At months 4 and 7 they have blood drawn for HbA1C measurement. The principal outcome variable is level of diabetic control as measured by 7-month HbA1c. The means for each group will be compared, and we will test the hypothesis that glycemic control as represented by 7-month HbA1C is not worse for the ASBG group than the FTBG group. Secondary outcome variables are compliance with testing and number of hypoglycemic episodes.
- Conditions
- Diabetes Mellitus
- Being tested
- Alternate site blood glucose testing
- Keywords
- Alternate Site, Blood Glucose Testing, Blood Sugar Testing, Hemoglobin A1C
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate site blood glucose testingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of diabetic control as measured by 7-month HbA1c.
Secondary outcomes (2)
Compliance with testing.
Number of hypoglycemic episodes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Food and Drug Administration (FDA)
- Investigators
- Caroline Apovian, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207207
- Sponsor's protocol ID
- Protocol # 03-004C
- Other IDs
- Contract #: 233-02-0077
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ellison JM, Stegmann JM, Colner SL, Michael RH, Sharma MK, Ervin KR, Horwitz DL. Rapid changes in postprandial blood glucose produce concentration differences at finger, forearm, and thigh sampling sites. Diabetes Care. 2002 Jun;25(6):961-4. doi: 10.2337/diacare.25.6.961.
PubMed 12032099Saaddine JB, Engelgau MM, Beckles GL, Gregg EW, Thompson TJ, Narayan KM. A diabetes report card for the United States: quality of care in the 1990s. Ann Intern Med. 2002 Apr 16;136(8):565-74. doi: 10.7326/0003-4819-136-8-200204160-00005.
PubMed 11955024Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
PubMed 9742976Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922Fineberg SE, Bergenstal RM, Bernstein RM, Laffel LM, Schwartz SL. Use of an automated device for alternative site blood glucose monitoring. Diabetes Care. 2001 Jul;24(7):1217-20. doi: 10.2337/diacare.24.7.1217.
PubMed 11423505Kuwa K, Nakayama T, Hoshino T, Tominaga M. Relationships of glucose concentrations in capillary whole blood, venous whole blood and venous plasma. Clin Chim Acta. 2001 May;307(1-2):187-92. doi: 10.1016/s0009-8981(01)00426-0.
PubMed 11369356Jungheim K, Koschinsky T. Glucose monitoring at the arm: risky delays of hypoglycemia and hyperglycemia detection. Diabetes Care. 2002 Jun;25(6):956-60. doi: 10.2337/diacare.25.6.956.
PubMed 12032098de Veciana M, Major CA, Morgan MA, Asrat T, Toohey JS, Lien JM, Evans AT. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. N Engl J Med. 1995 Nov 9;333(19):1237-41. doi: 10.1056/NEJM199511093331901.
PubMed 7565999
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Assess the Effect of Using Alternate Site Blood Glucose Testing Versus Finger-Tip Testing on Long-Term Glycemic Control.
- ClinicalTrials.gov ID
- NCT00207207
- Acronym / sponsor ID
- Protocol # 03-004C
- Conditions
- Diabetes Mellitus
- Keywords
- Alternate Site, Blood Glucose Testing, Blood Sugar Testing, Hemoglobin A1C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Food and Drug Administration (FDA)
- Study start
- Jul 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to assess the effect of using ASBG (alternate site blood glucose) versus FTBG (finger tip blood glucose) testing on long-term glycemic control in diabetics. Since ASBG measurements appear to lag behind FSBG measurements at times of changing glucose concentration, it is possible that ASBG measurements will yield lower postprandial readings than FTBG, potentially causing a negative impact on long-term control. It is also possible that since ASBG is reportedly more comfortable than FTBG testing, it's use might improve adherence to testing and improve long term control.
Detailed description
Patients undergo an initial screening visit. Inclusion criteria include adults 18 -70 years of age with type II diabetes currently using insulin and recording SMBG measurements. Exclusion criteria include history of severe hypoglycemic episodes, current use of ASBG measurements, serious co-morbid illness or pregnancy. For eligible subjects baseline data including HbA1C is obtained. The goal for enrollment is 176 subjects. Subjects are randomized into either a fingertip or an arm-testing group within strata of baseline HbA1C. Each subject who does not already have one receives a One Touch Ultra® SMBG device. All subjects receive training in the use of this device, but for those in the arm-testing group this includes training on obtaining samples from the forearm. Arm- testing subjects are encouraged to use arm testing as much as possible but to use finger testing if they are not able to obtain a sample from the arm. All subjects are asked to perform SMBG testing before breakfast, before dinner and 2 hours after dinner and to complete diaries of all SMBG readings. At 1, 3 and 5 months after the training visit subjects see a diabetes provider who makes adjustments in the therapeutic regimen based on the SMBG measurements, as they would during routine diabetes management. Diary sheets are then collected and the data they contain is entered into a database. At months 2, 4 and 7 subjects present for a visit to drop off their diary sheets. At months 4 and 7 they have blood drawn for HbA1C measurement. The principal outcome variable is level of diabetic control as measured by 7-month HbA1c. The means for each group will be compared, and we will test the hypothesis that glycemic control as represented by 7-month HbA1C is not worse for the ASBG group than the FTBG group. Secondary outcome variables are compliance with testing and number of hypoglycemic episodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria will include adults 18 -70 years of age with type II diabetes currently using insulin and recording SMBG measurements.
Key exclusion criteria (1 listed)
- Patients will be excluded who have a history of hypoglycemic episodes, within the last two years, requiring urgent medical attention, hypoglycemia resulting in cognitive impairment, a lack of symptoms during hypoglycemic episodes. Subjects will also be excluded who have type I DM as determined by the investigators on a case-by-case basis, subjects who already utilize ASBG measurements or who have serious co-morbid illness (unstable cardiovascular disease, metastatic CA). Pregnant patients will also be excluded because of the more intense diabetic control they require.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternate site blood glucose testing | Procedure or surgery | – |
Primary outcome
Level of diabetic control as measured by 7-month HbA1c.
2 secondary outcomes
Compliance with testing.
Number of hypoglycemic episodes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2009.
- Background: PubMed 12032099Ellison JM, Stegmann JM, Colner SL, Michael RH, Sharma MK, Ervin KR, Horwitz DL. Rapid changes in postprandial blood glucose produce concentration differences at finger, forearm, and thigh sampling sites. Diabetes Care. 2002 Jun;25(6):961-4. doi: 10.2337/diacare.25.6.961.
- Background: PubMed 11955024Saaddine JB, Engelgau MM, Beckles GL, Gregg EW, Thompson TJ, Narayan KM. A diabetes report card for the United States: quality of care in the 1990s. Ann Intern Med. 2002 Apr 16;136(8):565-74. doi: 10.7326/0003-4819-136-8-200204160-00005.
- Background: PubMed 9742976Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
- Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- Background: PubMed 11423505Fineberg SE, Bergenstal RM, Bernstein RM, Laffel LM, Schwartz SL. Use of an automated device for alternative site blood glucose monitoring. Diabetes Care. 2001 Jul;24(7):1217-20. doi: 10.2337/diacare.24.7.1217.
- Background: PubMed 11369356Kuwa K, Nakayama T, Hoshino T, Tominaga M. Relationships of glucose concentrations in capillary whole blood, venous whole blood and venous plasma. Clin Chim Acta. 2001 May;307(1-2):187-92. doi: 10.1016/s0009-8981(01)00426-0.
- Background: PubMed 12032098Jungheim K, Koschinsky T. Glucose monitoring at the arm: risky delays of hypoglycemia and hyperglycemia detection. Diabetes Care. 2002 Jun;25(6):956-60. doi: 10.2337/diacare.25.6.956.
- Background: PubMed 7565999de Veciana M, Major CA, Morgan MA, Asrat T, Toohey JS, Lien JM, Evans AT. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. N Engl J Med. 1995 Nov 9;333(19):1237-41. doi: 10.1056/NEJM199511093331901.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Apovian, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alternate site blood glucose testing in people with Diabetes Mellitus, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of diabetic control as measured by 7-month HbA1c.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00207207, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2009.