Type 1 Diabetes MellitusNCT02530450
Continuous Glucose Monitor in Children With Poorly Controlled Diabetes
An observational study of Type 1 Diabetes Mellitus, run by The University of Texas Health Science Center at San Antonio.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- continuous glucose monitoring (CGM)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Mar 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Subjects are pediatric, with a clinical diagnosis of diabetes for at least 6 months, who have been treated in the diabetic clinic for at least 3 months previously.
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
About this study
Official title: iPro Continuous Glucose Monitor in Children With Poorly Controlled Diabetes: A 6-Month, Randomized, Interventional Pilot Study
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.
Read the detailed description
The trial was designed as a six month, randomized, prospective, interventional pilot study of children with uncontrolled (HgbA1c > 8.5%) diabetes who were between the ages of 7-17 years of age. The purpose of the study was to determine the effect in glycemic control as measured by HgbA1c with use of iPro™ CGM at regularly scheduled clinic appointments. Recruitment for this study was limited to patients at the University of Texas Health Science Center in San Antonio Pediatric Diabetes Clinic from May 2011 to March 2013. Subjects were randomized into Group1 or Group 2 using sequentially numbered, opaque sealed envelopes (SNOSE).
All subjects had point-of-care HgbA1c (standard of care) and CGM data collected at time points 0, 3 months, and 6 months. After a regularly scheduled clinic appointment, all subjects and families at time 0 were counseled by a registered dietician regarding carbohydrate counting with a focus on minimizing errors in carbohydrate estimation, as is standard of care for patients with poorly controlled diabetes in our clinic. At time 0, subjects in both Group 1 and 2 had CGM placement after meeting with the dietician. Group 1 subjects were blinded to the first CGM data, meaning that they did not review the CGM download data. Group 2 was scheduled to return to clinic within 2 weeks of placement to meet with a pediatric endocrinologist involved in the study to interpret the CGM results and make adjustments to insulin regimen if appropriate. Both Groups 1 and 2 were not blinded to CGM data at 3 months and 6 months. Again, the CGM was placed after their regularly scheduled diabetes clinic appointments and all families returned within 2 weeks of these visits to meet with the pediatric endocrinologist to interpret the data and adjust the insulin regimen if necessary.
The iPro™ CGM was worn for a minimum of 48 hours (2 days), maximum 96 hours (4 days). Participants were instructed to complete a minimum of 4 SMBG records daily while wearing the iPro™ CGM for system calibration purposes. Subjects documented SMBGs, meal times, carbohydrate intake, insulin doses, exercise, and any hypoglycemic symptoms in a log book for correlation to CGM data.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- continuous glucose monitoring (CGM)
- Keywords
- children, poor adherence, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous glucose monitoring (CGM)Device
Also called iPRO
All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Initially blinded to continuous glucose monitoring (CGM) data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use Receives: Device: continuous glucose monitoring (CGM) | |
| Group 2 | Never blinded to continuous glucose monitoring (CGM) data Receives: Device: continuous glucose monitoring (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure Was Change in HgbA1c
Measured: 0 months, 3 months and 6 months
Secondary outcomes (1)
% Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startMay 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic MiniMed, Inc.
- Responsible party
- Sponsor
- Investigators
- Maria Rayas, MD, Principal investigator, UT Health Science Center San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530450
- Sponsor's protocol ID
- HSC20110049H
- Status last verified
- Sep 2017
- First submitted
- 19 Aug 2015
- Last updated
- 6 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Maahs DM, West NA, Lawrence JM, Mayer-Davis EJ. Epidemiology of type 1 diabetes. Endocrinol Metab Clin North Am. 2010 Sep;39(3):481-97. doi: 10.1016/j.ecl.2010.05.011.
PubMed 20723815Diabetes 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 8366922Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.
PubMed 16371630Borus JS, Laffel L. Adherence challenges in the management of type 1 diabetes in adolescents: prevention and intervention. Curr Opin Pediatr. 2010 Aug;22(4):405-11. doi: 10.1097/MOP.0b013e32833a46a7.
PubMed 20489639Boland E, Monsod T, Delucia M, Brandt CA, Fernando S, Tamborlane WV. Limitations of conventional methods of self-monitoring of blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1858-62. doi: 10.2337/diacare.24.11.1858.
PubMed 11679447Gandrud LM, Xing D, Kollman C, Block JM, Kunselman B, Wilson DM, Buckingham BA. The Medtronic Minimed Gold continuous glucose monitoring system: an effective means to discover hypo- and hyperglycemia in children under 7 years of age. Diabetes Technol Ther. 2007 Aug;9(4):307-16. doi: 10.1089/dia.2007.0026.
PubMed 17705686Bode BW, Gross TM, Thornton KR, Mastrototaro JJ. Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. Diabetes Res Clin Pract. 1999 Dec;46(3):183-90. doi: 10.1016/s0168-8227(99)00113-8.
PubMed 10624783Tanenberg R, Bode B, Lane W, Levetan C, Mestman J, Harmel AP, Tobian J, Gross T, Mastrototaro J. Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: a randomized controlled trial. Mayo Clin Proc. 2004 Dec;79(12):1521-6. doi: 10.4065/79.12.1521.
PubMed 15595336Chetty VT, Almulla A, Odueyungbo A, Thabane L. The effect of continuous subcutaneous glucose monitoring (CGMS) versus intermittent whole blood finger-stick glucose monitoring (SBGM) on hemoglobin A1c (HBA1c) levels in Type I diabetic patients: a systematic review. Diabetes Res Clin Pract. 2008 Jul;81(1):79-87. doi: 10.1016/j.diabres.2008.02.014. Epub 2008 Apr 15.
PubMed 18417243Kaufman FR, Gibson LC, Halvorson M, Carpenter S, Fisher LK, Pitukcheewanont P. A pilot study of the continuous glucose monitoring system: clinical decisions and glycemic control after its use in pediatric type 1 diabetic subjects. Diabetes Care. 2001 Dec;24(12):2030-4. doi: 10.2337/diacare.24.12.2030.
PubMed 11723078Ludvigsson J, Hanas R. Continuous subcutaneous glucose monitoring improved metabolic control in pediatric patients with type 1 diabetes: a controlled crossover study. Pediatrics. 2003 May;111(5 Pt 1):933-8. doi: 10.1542/peds.111.5.933.
PubMed 12728068Lagarde WH, Barrows FP, Davenport ML, Kang M, Guess HA, Calikoglu AS. Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial. Pediatr Diabetes. 2006 Jun;7(3):159-64. doi: 10.1111/j.1399-543X.2006.00162.x.
PubMed 16787523Schaepelynck-Belicar P, Vague P, Simonin G, Lassmann-Vague V. Improved metabolic control in diabetic adolescents using the continuous glucose monitoring system (CGMS). Diabetes Metab. 2003 Dec;29(6):608-12. doi: 10.1016/s1262-3636(07)70076-9.
PubMed 14707890Ryan EA, Germsheid J. Use of continuous glucose monitoring system in the management of severe hypoglycemia. Diabetes Technol Ther. 2009 Oct;11(10):635-9. doi: 10.1089/dia.2009.0042.
PubMed 19821755Hood KK, Rohan JM, Peterson CM, Drotar D. Interventions with adherence-promoting components in pediatric type 1 diabetes: meta-analysis of their impact on glycemic control. Diabetes Care. 2010 Jul;33(7):1658-64. doi: 10.2337/dc09-2268.
PubMed 20587726
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iPro Continuous Glucose Monitor in Children With Poorly Controlled Diabetes: A 6-Month, Randomized, Interventional Pilot Study
- ClinicalTrials.gov ID
- NCT02530450
- Acronym / sponsor ID
- HSC20110049H
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- children, poor adherence, continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Medtronic MiniMed, Inc.
- Study start
- May 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Posted 23 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial was designed as a six month, randomized, prospective, interventional pilot study of children with uncontrolled (HgbA1c > 8.5%) diabetes who were between the ages of 7-17 years of age. The purpose of the study was to determine the effect in glycemic control as measured by HgbA1c with use of iPro™ CGM at regularly scheduled clinic appointments. Recruitment for this study was limited to patients at the University of Texas Health Science Center in San Antonio Pediatric Diabetes Clinic from May 2011 to March 2013. Subjects were randomized into Group1 or Group 2 using sequentially numbered, opaque sealed envelopes (SNOSE).
All subjects had point-of-care HgbA1c (standard of care) and CGM data collected at time points 0, 3 months, and 6 months. After a regularly scheduled clinic appointment, all subjects and families at time 0 were counseled by a registered dietician regarding carbohydrate counting with a focus on minimizing errors in carbohydrate estimation, as is standard of care for patients with poorly controlled diabetes in our clinic. At time 0, subjects in both Group 1 and 2 had CGM placement after meeting with the dietician. Group 1 subjects were blinded to the first CGM data, meaning that they did not review the CGM download data. Group 2 was scheduled to return to clinic within 2 weeks of placement to meet with a pediatric endocrinologist involved in the study to interpret the CGM results and make adjustments to insulin regimen if appropriate. Both Groups 1 and 2 were not blinded to CGM data at 3 months and 6 months. Again, the CGM was placed after their regularly scheduled diabetes clinic appointments and all families returned within 2 weeks of these visits to meet with the pediatric endocrinologist to interpret the data and adjust the insulin regimen if necessary.
The iPro™ CGM was worn for a minimum of 48 hours (2 days), maximum 96 hours (4 days). Participants were instructed to complete a minimum of 4 SMBG records daily while wearing the iPro™ CGM for system calibration purposes. Subjects documented SMBGs, meal times, carbohydrate intake, insulin doses, exercise, and any hypoglycemic symptoms in a log book for correlation to CGM data.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: continuous glucose monitoring (CGM)Initially blinded to continuous glucose monitoring (CGM) data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use |
| Group 2 | – | Device: continuous glucose monitoring (CGM)Never blinded to continuous glucose monitoring (CGM) data |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects are pediatric, with a clinical diagnosis of diabetes for at least 6 months, who have been treated in the diabetic clinic for at least 3 months previously.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| continuous glucose monitoring (CGM)Also: iPROAll subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points. | Device | Group 1, Group 2 |
Primary outcome
The Primary Outcome Measure Was Change in HgbA1c
Time frame: 0 months, 3 months and 6 months
1 secondary outcome
% Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia
Time frame: 3 months and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20723815Maahs DM, West NA, Lawrence JM, Mayer-Davis EJ. Epidemiology of type 1 diabetes. Endocrinol Metab Clin North Am. 2010 Sep;39(3):481-97. doi: 10.1016/j.ecl.2010.05.011.
- 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 16371630Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.
- Background: PubMed 20489639Borus JS, Laffel L. Adherence challenges in the management of type 1 diabetes in adolescents: prevention and intervention. Curr Opin Pediatr. 2010 Aug;22(4):405-11. doi: 10.1097/MOP.0b013e32833a46a7.
- Background: PubMed 11679447Boland E, Monsod T, Delucia M, Brandt CA, Fernando S, Tamborlane WV. Limitations of conventional methods of self-monitoring of blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1858-62. doi: 10.2337/diacare.24.11.1858.
- Background: PubMed 17705686Gandrud LM, Xing D, Kollman C, Block JM, Kunselman B, Wilson DM, Buckingham BA. The Medtronic Minimed Gold continuous glucose monitoring system: an effective means to discover hypo- and hyperglycemia in children under 7 years of age. Diabetes Technol Ther. 2007 Aug;9(4):307-16. doi: 10.1089/dia.2007.0026.
- Background: PubMed 10624783Bode BW, Gross TM, Thornton KR, Mastrototaro JJ. Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. Diabetes Res Clin Pract. 1999 Dec;46(3):183-90. doi: 10.1016/s0168-8227(99)00113-8.
- Background: PubMed 15595336Tanenberg R, Bode B, Lane W, Levetan C, Mestman J, Harmel AP, Tobian J, Gross T, Mastrototaro J. Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: a randomized controlled trial. Mayo Clin Proc. 2004 Dec;79(12):1521-6. doi: 10.4065/79.12.1521.
- Background: PubMed 18417243Chetty VT, Almulla A, Odueyungbo A, Thabane L. The effect of continuous subcutaneous glucose monitoring (CGMS) versus intermittent whole blood finger-stick glucose monitoring (SBGM) on hemoglobin A1c (HBA1c) levels in Type I diabetic patients: a systematic review. Diabetes Res Clin Pract. 2008 Jul;81(1):79-87. doi: 10.1016/j.diabres.2008.02.014. Epub 2008 Apr 15.
- Background: PubMed 11723078Kaufman FR, Gibson LC, Halvorson M, Carpenter S, Fisher LK, Pitukcheewanont P. A pilot study of the continuous glucose monitoring system: clinical decisions and glycemic control after its use in pediatric type 1 diabetic subjects. Diabetes Care. 2001 Dec;24(12):2030-4. doi: 10.2337/diacare.24.12.2030.
- Background: PubMed 12728068Ludvigsson J, Hanas R. Continuous subcutaneous glucose monitoring improved metabolic control in pediatric patients with type 1 diabetes: a controlled crossover study. Pediatrics. 2003 May;111(5 Pt 1):933-8. doi: 10.1542/peds.111.5.933.
- Background: PubMed 16787523Lagarde WH, Barrows FP, Davenport ML, Kang M, Guess HA, Calikoglu AS. Continuous subcutaneous glucose monitoring in children with type 1 diabetes mellitus: a single-blind, randomized, controlled trial. Pediatr Diabetes. 2006 Jun;7(3):159-64. doi: 10.1111/j.1399-543X.2006.00162.x.
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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.
Maria Rayas, MD principal investigator
UT Health Science Center San Antonio
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by The University of Texas Health Science Center at San Antonio.
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 9 inclusion and 9 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 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Outcome Measure Was Change in HgbA1c (time frame: 0 months, 3 months and 6 months). 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 NCT02530450, which also lists 18 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 6 Oct 2017.