Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management
Introduction The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation. Methods The single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashio...
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Published in | Diabetes therapy Vol. 8; no. 4; pp. 811 - 819 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
Cheshire
Springer Healthcare
01.08.2017
Springer Nature B.V |
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Abstract | Introduction
The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation.
Methods
The single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano
®
and an intervention group using SMBG with iPhone plus glucose meter (iBGStar
®
). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values.
Results
Baseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar
®
group compared to the control group (−0.16 vs. −0.51,
p
= 0.04). The total insulin dose increased significantly in the iBGStar
®
group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (−1.4 ± 10.0 vs. −3.9 ± 12.5,
p
= 0.32).
Conclusion
The use of iBGStar
®
resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia.
Clinical trial registration
ClinicalTrials.gov: NCT01825382.
Funding
Sanofi. |
---|---|
AbstractList | The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation.
The single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano
and an intervention group using SMBG with iPhone plus glucose meter (iBGStar
). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values.
Baseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar
group compared to the control group (-0.16 vs. -0.51, p = 0.04). The total insulin dose increased significantly in the iBGStar
group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (-1.4 ± 10.0 vs. -3.9 ± 12.5, p = 0.32).
The use of iBGStar
resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia.
ClinicalTrials.gov: NCT01825382.
Sanofi. The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation.INTRODUCTIONThe role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation.The single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano® and an intervention group using SMBG with iPhone plus glucose meter (iBGStar®). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values.METHODSThe single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano® and an intervention group using SMBG with iPhone plus glucose meter (iBGStar®). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values.Baseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar® group compared to the control group (-0.16 vs. -0.51, p = 0.04). The total insulin dose increased significantly in the iBGStar® group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (-1.4 ± 10.0 vs. -3.9 ± 12.5, p = 0.32).RESULTSBaseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar® group compared to the control group (-0.16 vs. -0.51, p = 0.04). The total insulin dose increased significantly in the iBGStar® group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (-1.4 ± 10.0 vs. -3.9 ± 12.5, p = 0.32).The use of iBGStar® resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia.CONCLUSIONThe use of iBGStar® resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia.ClinicalTrials.gov: NCT01825382.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov: NCT01825382.Sanofi.FUNDINGSanofi. Introduction The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation. Methods The single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano ® and an intervention group using SMBG with iPhone plus glucose meter (iBGStar ® ). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values. Results Baseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar ® group compared to the control group (−0.16 vs. −0.51, p = 0.04). The total insulin dose increased significantly in the iBGStar ® group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (−1.4 ± 10.0 vs. −3.9 ± 12.5, p = 0.32). Conclusion The use of iBGStar ® resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia. Clinical trial registration ClinicalTrials.gov: NCT01825382. Funding Sanofi. IntroductionThe role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation.MethodsThe single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano® and an intervention group using SMBG with iPhone plus glucose meter (iBGStar®). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values.ResultsBaseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar® group compared to the control group (−0.16 vs. −0.51, p = 0.04). The total insulin dose increased significantly in the iBGStar® group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (−1.4 ± 10.0 vs. −3.9 ± 12.5, p = 0.32).ConclusionThe use of iBGStar® resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia.Clinical trial registration ClinicalTrials.gov: NCT01825382.FundingSanofi. |
Author | Garg, Satish K. Shah, Viral N. Snell-Bergeon, Janet K. Beatson, Christie Akturk, Halis K. |
Author_xml | – sequence: 1 givenname: Satish K. surname: Garg fullname: Garg, Satish K. email: Satish.garg@ucdenver.edu organization: Barbara Davis Center for Diabetes, University of Colorado Anschutz Campus, School of Medicine, University of Colorado – sequence: 2 givenname: Viral N. surname: Shah fullname: Shah, Viral N. organization: Barbara Davis Center for Diabetes, University of Colorado Anschutz Campus, School of Medicine, University of Colorado – sequence: 3 givenname: Halis K. surname: Akturk fullname: Akturk, Halis K. organization: Barbara Davis Center for Diabetes, University of Colorado Anschutz Campus, School of Medicine, University of Colorado – sequence: 4 givenname: Christie surname: Beatson fullname: Beatson, Christie organization: Barbara Davis Center for Diabetes, University of Colorado Anschutz Campus – sequence: 5 givenname: Janet K. surname: Snell-Bergeon fullname: Snell-Bergeon, Janet K. organization: Barbara Davis Center for Diabetes, University of Colorado Anschutz Campus |
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Cites_doi | 10.1089/dia.2014.0193 10.1089/dia.2008.0069 10.1056/NEJM199309303291401 10.1517/17530059.2013.839984 10.2337/dc12-0669 10.1001/jama.2014.3201 10.1007/s11892-015-0619-0 10.2337/diacare.10.5.617 10.1007/s13300-014-0092-9 10.2337/diaclin.28.3.127 10.2337/dc15-0078 10.1111/j.1742-1241.2009.02271.x 10.2337/dc12-1770 10.1016/j.diabres.2012.01.027 |
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Keywords | Continuous glucose monitoring iPhone Mobile technology Glucometer Type 1 diabetes Self-monitoring of blood glucose Diabetes Hypoglycemia iBGStar |
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Snippet | Introduction
The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further... The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation. The... IntroductionThe role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further... The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further... |
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StartPage | 811 |
SubjectTerms | Cardiology Diabetes Disease management Endocrinology Glucose Glucose monitoring Hypoglycemia Insulin Internal Medicine Medicine Medicine & Public Health Original Research Portable computers |
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Title | Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management |
URI | https://link.springer.com/article/10.1007/s13300-017-0272-5 https://www.ncbi.nlm.nih.gov/pubmed/28555339 https://www.proquest.com/docview/1925989528 https://www.proquest.com/docview/1903941622 https://pubmed.ncbi.nlm.nih.gov/PMC5544609 |
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