Diabetic NephropathiesALPHANCT03885362
Assessment of the Accuracy of Continuous Glucose Sensors in People With Diabetes Undergoing Haemodialysis
A study testing Dexcom G6 and Abbott Freestyle Libre in people with Diabetic Nephropathies and Type 1 Diabetes Mellitus, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of the study is to assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to the reference standard YSI (Yellow Spring Instruments) glucose in people with diabetes undergoing haemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathies, Type 1 Diabetes Mellitus, Chronic Kidney Diseases
- What is being tested?
- Dexcom G6 and Abbott Freestyle Libre
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Dec 2019to 1 Jul 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years of age
- Diabetes, with insulin treatment for over 6 months or on sulphonylureas
- Chronic kidney disease requiring haemodialysis three times per week
Who cannot join
- Pregnant or planning pregnancy
- Breastfeeding
- Enrolled in other clinical trials
- Have active malignancy or under investigation for malignancy
- Severe visual impairment
- Reduced manual dexterity
- Unable to participate due to other factors, as assessed by the Chief Investigators
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London/NHS trust Renal Unit
London
About this study
The purpose of the study is to assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to the reference standard YSI (Yellow Spring Instruments) glucose in people with diabetes undergoing haemodialysis. The Dexcom G6 is a continuous glucose monitoring system that gives blood glucose values in real-time and includes alarms if the glucose is very low or high. The Abbott FreeStyle ibre flash system is an intermittent glucose monitor that shows the blood glucose values when it is waved near the sensor and does not include alarms. The YSI glucose analysis will take place as a normal part of haemodialysis, by testing blood glucose levels during the haemodialysis session. The study will last 28 days per participant
Read the detailed description
Diabetic nephropathy is the leading cause of end-stage renal failure (ESRF), representing approximately 40% of people requiring long-term renal replacement therapy and maintenance haemodialysis [1]. Mortality and morbidity within this cohort is high, with the predominant cause being cardiovascular disease (CVD) [2]. Glycaemic control in many haemodialysis dependent patients with diabetes is poor and may lead to additional renal complications, including high interdialytic weight gain, electrolyte imbalance, and amputations [3]. Current clinical guidance is centred around the prevention of hyperglycaemia and microvascular complications of diabetes.
Glucose self-management is particularly challenging due to cyclical changes in insulin sensitivity and circulating insulin concentrations. Hypoglycemia is common due to impaired renal gluconeogenesis, malnutrition, and the increased half-life of insulin and hypoglycemic agents [4, 5]. Additionally, people with chronic kidney disease and diabetes may have other diabetes complications such as retinopathy, neuropathy, and impaired awareness of hypoglycaemia, which can make self-management more difficult.
Overall assessment of glycaemic control is also more complex as classical markers of glycemic control (i.e. HbA1c and fructosamine) may be misleading due to the variable underestimation of glycaemia resulting from analytical interferences, shortened half-life of red blood cells and abnormal albumin level [6-8]. Further limitations of HbA1c is that it is not informative regarding glycemic control on the days on and off dialysis, and intra-day glycaemic variability.
Frequent capillary blood glucose tests or self-monitoring of blood glucose (SMBG) is the traditional and one of the most effective ways to track an individuals' blood glucose levels. Real-time continuous glucose monitoring (CGM) has been shown to improve overall glucose control, reduce hypoglycaemia in people with an HbA1c <7.0%, and may reduce severe hypoglycaemia [9-11]. In addition, they provide alert and alarm features for hypo- and hyperglycaemia, and for times of rapid glucose change.
Flash glucose monitoring does not provide real-time data with alerts and alarms, but allows users to retrospectively review the preceding 8 hours of continuous glucose data, along with a contemporary estimated blood glucose value and trend line. The system consists of a subcutaneous sensor placed on the back of the upper arm, which measures glucose in the interstitial fluid every minute. The glucose data are made available when the user chooses to swipe the reader over the sensor.
CGM has the potential to reduce HbA1c and minimize exposure to hypoglycaemia while addressing diabetes distress. Flash glucose monitoring may reduce exposure to hypoglycaemia in people with insulin-treated diabetes.
The accuracy of CGM and flash in people with diabetes on haemodialysis has not been described. In this clinical study, the investigators will assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to YSI (Yellow Spring Instruments) glucose in people undergoing haemodialysis.
- Being tested
- Dexcom G6 and Abbott Freestyle Libre
- Keywords
- Type 1 Diabetes Mellitus, Chronic Kidney Diseases
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 1, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6 and Abbott Freestyle LibreDevice
Dexcom G6 - continuous glucose monitoring device - blinded. CE mark 2018 Abbott Freestyle Libre - flash glucose monitoring device. CE mark 2014
| Study group | Role | What they receive |
|---|---|---|
| Dexcom G6 and Abbott Freestyle Libre | Experimental | Participants will have a Dexcom G6 sensor and Abbott FreeStyle Libre sensor inserted in the abdomen and upper arm respectively. Participants will be asked to swipe the FreeStyle Libre reader across the sensor a minimum of every 8 hours. Participants will be asked to continue their usual regimen of self-monitoring capillary blood glucose (SMBG).
During haemodialysis, a dialysis circuit blood sample will be drawn at 0 (pre-dialysis) 30, 60, 90, 120, 150, 180, 210 and 240 minutes and immediately after dialysis. Samples from the circuit will be analysed on the YSI glucose analyser. Participants will be asked to change the FreeStyle Libre sensors at day 14. The blinded CGM data will be uploaded at the time of each sensor change by the research team. Receives: Device: Dexcom G6 and Abbott Freestyle Libre |
What is being measured
The primary outcome is the main question the study is designed to answer.
MARD between G6 and YSI
Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis
Measured: 28 days
MARD between Libre and YSI
Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis
Measured: 28 days
Secondary outcomes (17)
HbA1c
Glycated Haemoglobin
Measured: 28 days
MARD for G6 and YSI <3.9mmol/L
Mean absolute relative difference between Dexcom G6 and YSI glucose <3.9mmol/L
Measured: 28 days
MARD for Libre and YSI <3.9mmol/L
Mean absolute relative difference between Libre and YSI glucose <3.9mmol/L
Measured: 28 days
MARD for Libre and YSI 3.9-10mmol/L
Mean absolute relative difference between Libre and YSI glucose 3.9-10mmol/L
Measured: 28 days
MARD for Libre and YSI >10mmol/L
Mean absolute relative difference between Libre and YSI glucose >10mmol/L
Measured: 28 days
MARD for G6 and YSI 3.9-10mmol/L
Mean absolute relative difference between Dexcom G6 and YSI glucose 3.9-10mmol/L
Measured: 28 days
MARD for G6 and YSI >10mmol/L
Mean absolute relative difference between Dexcom G6 and YSI glucose >10mmol/L
Measured: 28 days
MARD for G6 and YSI 24hr pre
Mean absolute relative difference between Dexcom G6 and YSI glucose during 24 hours prior to heamodialysis
Measured: 24 hours
MARD for Libre and YSI 24hr pre
Mean absolute relative difference between Libre and YSI glucose during 24 hours prior to heamodialysis
Measured: 24 hours
MARD for Libre and YSI 24hr post
Mean absolute relative difference between Libre and YSI glucose during 24 hours after heamodialysis
Measured: 24 hours
MARD for G6 and YSI 24hr post
Mean absolute relative difference between Dexcom G6 and YSI glucose during 24 hours after heamodialysis
Measured: 24 hours
CEG analysis G6 and YSI
Clarke Error Grid analysis between Dexcom G6 and YSI glucose during haemodialysis
Measured: 28 DAYS
CEG analysis Libre and YSI
Clarke Error Grid analysis between Libre and YSI glucose during haemodialysis
Measured: 28 DAYS
Severe hypoglycaemia
Episodes of severe hypoglycaemia
Measured: 28 days
DKA
Diabetic Ketoacidosis
Measured: 28 days
Sensor failure
Events of G6/libre sensor failure
Measured: 28 days
Missing glucose data
Missing blood glucose data for G6/libre measured by number of missing data points
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start11 Dec 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Oliver, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885362
- Sponsor's protocol ID
- 18SM4938
- Acronym
- ALPHA
- Status last verified
- Aug 2022
- First submitted
- 22 Feb 2019
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
PubMed 17986697Levin A. Clinical epidemiology of cardiovascular disease in chronic kidney disease prior to dialysis. Semin Dial. 2003 Mar-Apr;16(2):101-5. doi: 10.1046/j.1525-139x.2003.16025.x.
PubMed 12641872Creme D, McCafferty K. Glycaemic Control Impact on Renal Endpoints in Diabetic Patients on Haemodialysis. Int J Nephrol. 2015;2015:523521. doi: 10.1155/2015/523521. Epub 2015 Sep 20.
PubMed 26457201National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012 Nov;60(5):850-86. doi: 10.1053/j.ajkd.2012.07.005.
PubMed 23067652Haviv YS, Sharkia M, Safadi R. Hypoglycemia in patients with renal failure. Ren Fail. 2000 Mar;22(2):219-23. doi: 10.1081/jdi-100100866.
PubMed 10803766Lee KF, Szeto YT, Benzie IF. Glycohaemoglobin measurement: methodological differences in relation to interference by urea. Acta Diabetol. 2002 Apr;39(1):35-9. doi: 10.1007/s005920200010.
PubMed 12043937Inaba M, Okuno S, Kumeda Y, Yamada S, Imanishi Y, Tabata T, Okamura M, Okada S, Yamakawa T, Ishimura E, Nishizawa Y; Osaka CKD Expert Research Group. Glycated albumin is a better glycemic indicator than glycated hemoglobin values in hemodialysis patients with diabetes: effect of anemia and erythropoietin injection. J Am Soc Nephrol. 2007 Mar;18(3):896-903. doi: 10.1681/ASN.2006070772. Epub 2007 Jan 31.
PubMed 17267743Joy MS, Cefalu WT, Hogan SL, Nachman PH. Long-term glycemic control measurements in diabetic patients receiving hemodialysis. Am J Kidney Dis. 2002 Feb;39(2):297-307. doi: 10.1053/ajkd.2002.30549.
PubMed 11840370Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011 Jul 7;343:d3805. doi: 10.1136/bmj.d3805.
PubMed 21737469Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
PubMed 28118453Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Olafsdottir AF, Frid A, Wedel H, Ahlen E, Nystrom T, Hellman J. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):379-387. doi: 10.1001/jama.2016.19976.
PubMed 28118454Avari P, Pushparatnam R, Leelarathna L, Tan T, Frankel AH, Oliver N, Reddy M. Accuracy of the Dexcom G7 Continuous Glucose Monitoring Sensors in People with Diabetes Undergoing Hemodialysis (ALPHA-2 Study). Diabetes Technol Ther. 2025 May;27(5):402-406. doi: 10.1089/dia.2024.0575. Epub 2025 Feb 5.
PubMed 39788885
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy of Continuous Glucose Sensors in People With Diabetes Undergoing Haemodialysis
- ClinicalTrials.gov ID
- NCT03885362
- Acronym / sponsor ID
- ALPHA / 18SM4938
- Keywords
- Type 1 Diabetes Mellitus, Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 21 Mar 2019 (actual)
- 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 purpose of the study is to assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to the reference standard YSI (Yellow Spring Instruments) glucose in people with diabetes undergoing haemodialysis. The Dexcom G6 is a continuous glucose monitoring system that gives blood glucose values in real-time and includes alarms if the glucose is very low or high. The Abbott FreeStyle ibre flash system is an intermittent glucose monitor that shows the blood glucose values when it is waved near the sensor and does not include alarms. The YSI glucose analysis will take place as a normal part of haemodialysis, by testing blood glucose levels during the haemodialysis session. The study will last 28 days per participant
Detailed description
Diabetic nephropathy is the leading cause of end-stage renal failure (ESRF), representing approximately 40% of people requiring long-term renal replacement therapy and maintenance haemodialysis [1]. Mortality and morbidity within this cohort is high, with the predominant cause being cardiovascular disease (CVD) [2]. Glycaemic control in many haemodialysis dependent patients with diabetes is poor and may lead to additional renal complications, including high interdialytic weight gain, electrolyte imbalance, and amputations [3]. Current clinical guidance is centred around the prevention of hyperglycaemia and microvascular complications of diabetes.
Glucose self-management is particularly challenging due to cyclical changes in insulin sensitivity and circulating insulin concentrations. Hypoglycemia is common due to impaired renal gluconeogenesis, malnutrition, and the increased half-life of insulin and hypoglycemic agents [4, 5]. Additionally, people with chronic kidney disease and diabetes may have other diabetes complications such as retinopathy, neuropathy, and impaired awareness of hypoglycaemia, which can make self-management more difficult.
Overall assessment of glycaemic control is also more complex as classical markers of glycemic control (i.e. HbA1c and fructosamine) may be misleading due to the variable underestimation of glycaemia resulting from analytical interferences, shortened half-life of red blood cells and abnormal albumin level [6-8]. Further limitations of HbA1c is that it is not informative regarding glycemic control on the days on and off dialysis, and intra-day glycaemic variability.
Frequent capillary blood glucose tests or self-monitoring of blood glucose (SMBG) is the traditional and one of the most effective ways to track an individuals' blood glucose levels. Real-time continuous glucose monitoring (CGM) has been shown to improve overall glucose control, reduce hypoglycaemia in people with an HbA1c <7.0%, and may reduce severe hypoglycaemia [9-11]. In addition, they provide alert and alarm features for hypo- and hyperglycaemia, and for times of rapid glucose change.
Flash glucose monitoring does not provide real-time data with alerts and alarms, but allows users to retrospectively review the preceding 8 hours of continuous glucose data, along with a contemporary estimated blood glucose value and trend line. The system consists of a subcutaneous sensor placed on the back of the upper arm, which measures glucose in the interstitial fluid every minute. The glucose data are made available when the user chooses to swipe the reader over the sensor.
CGM has the potential to reduce HbA1c and minimize exposure to hypoglycaemia while addressing diabetes distress. Flash glucose monitoring may reduce exposure to hypoglycaemia in people with insulin-treated diabetes.
The accuracy of CGM and flash in people with diabetes on haemodialysis has not been described. In this clinical study, the investigators will assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to YSI (Yellow Spring Instruments) glucose in people undergoing haemodialysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexcom G6 and Abbott Freestyle Libre | Experimental | Device: Dexcom G6 and Abbott Freestyle LibreParticipants will have a Dexcom G6 sensor and Abbott FreeStyle Libre sensor inserted in the abdomen and upper arm respectively. Participants will be asked to swipe the FreeStyle Libre reader across the sensor a minimum of every 8 hours. Participants will be asked to continue their usual regimen of self-monitoring capillary blood glucose (SMBG). During haemodialysis, a dialysis circuit blood sample will be drawn at 0 (pre-dialysis) 30, 60, 90, 120, 150, 180, 210 and 240 minutes and immediately after dialysis. Samples from the circuit will be analysed on the YSI glucose analyser. Participants will be asked to change the FreeStyle Libre sensors at day 14. The blinded CGM data will be uploaded at the time of each sensor change by the research team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults >18 years of age
- Diabetes, with insulin treatment for over 6 months or on sulphonylureas
- Chronic kidney disease requiring haemodialysis three times per week
Key exclusion criteria (7 listed)
- Pregnant or planning pregnancy
- Breastfeeding
- Enrolled in other clinical trials
- Have active malignancy or under investigation for malignancy
- Severe visual impairment
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 |
|---|---|---|
| Dexcom G6 and Abbott Freestyle LibreDexcom G6 - continuous glucose monitoring device - blinded. CE mark 2018 Abbott Freestyle Libre - flash glucose monitoring device. CE mark 2014 | Device | Dexcom G6 and Abbott Freestyle Libre |
Primary outcome
MARD between G6 and YSI
Time frame: 28 days
Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis
MARD between Libre and YSI
Time frame: 28 days
Mean absolute relative difference between Dexcom G6 and YSI glucose during haemodialysis
17 secondary outcomes
HbA1c
Time frame: 28 days
MARD for G6 and YSI <3.9mmol/L
Time frame: 28 days
MARD for Libre and YSI <3.9mmol/L
Time frame: 28 days
MARD for Libre and YSI 3.9-10mmol/L
Time frame: 28 days
MARD for Libre and YSI >10mmol/L
Time frame: 28 days
MARD for G6 and YSI 3.9-10mmol/L
Time frame: 28 days
MARD for G6 and YSI >10mmol/L
Time frame: 28 days
MARD for G6 and YSI 24hr pre
Time frame: 24 hours
MARD for Libre and YSI 24hr pre
Time frame: 24 hours
MARD for Libre and YSI 24hr post
Time frame: 24 hours
MARD for G6 and YSI 24hr post
Time frame: 24 hours
CEG analysis G6 and YSI
Time frame: 28 DAYS
CEG analysis Libre and YSI
Time frame: 28 DAYS
Severe hypoglycaemia
Time frame: 28 days
DKA
Time frame: 28 days
Sensor failure
Time frame: 28 days
Missing glucose data
Time frame: 28 days
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 5 Aug 2022.
- Background: PubMed 17986697Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
- Background: PubMed 12641872Levin A. Clinical epidemiology of cardiovascular disease in chronic kidney disease prior to dialysis. Semin Dial. 2003 Mar-Apr;16(2):101-5. doi: 10.1046/j.1525-139x.2003.16025.x.
- Background: PubMed 26457201Creme D, McCafferty K. Glycaemic Control Impact on Renal Endpoints in Diabetic Patients on Haemodialysis. Int J Nephrol. 2015;2015:523521. doi: 10.1155/2015/523521. Epub 2015 Sep 20.
- Background: PubMed 23067652National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012 Nov;60(5):850-86. doi: 10.1053/j.ajkd.2012.07.005.
- Background: PubMed 10803766Haviv YS, Sharkia M, Safadi R. Hypoglycemia in patients with renal failure. Ren Fail. 2000 Mar;22(2):219-23. doi: 10.1081/jdi-100100866.
- Background: PubMed 12043937Lee KF, Szeto YT, Benzie IF. Glycohaemoglobin measurement: methodological differences in relation to interference by urea. Acta Diabetol. 2002 Apr;39(1):35-9. doi: 10.1007/s005920200010.
- Background: PubMed 17267743Inaba M, Okuno S, Kumeda Y, Yamada S, Imanishi Y, Tabata T, Okamura M, Okada S, Yamakawa T, Ishimura E, Nishizawa Y; Osaka CKD Expert Research Group. Glycated albumin is a better glycemic indicator than glycated hemoglobin values in hemodialysis patients with diabetes: effect of anemia and erythropoietin injection. J Am Soc Nephrol. 2007 Mar;18(3):896-903. doi: 10.1681/ASN.2006070772. Epub 2007 Jan 31.
- Background: PubMed 11840370Joy MS, Cefalu WT, Hogan SL, Nachman PH. Long-term glycemic control measurements in diabetic patients receiving hemodialysis. Am J Kidney Dis. 2002 Feb;39(2):297-307. doi: 10.1053/ajkd.2002.30549.
- Background: PubMed 21737469Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011 Jul 7;343:d3805. doi: 10.1136/bmj.d3805.
- Background: PubMed 28118453Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
- Background: PubMed 28118454Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Olafsdottir AF, Frid A, Wedel H, Ahlen E, Nystrom T, Hellman J. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):379-387. doi: 10.1001/jama.2016.19976.
- Derived from this study: PubMed 39788885Avari P, Pushparatnam R, Leelarathna L, Tan T, Frankel AH, Oliver N, Reddy M. Accuracy of the Dexcom G7 Continuous Glucose Monitoring Sensors in People with Diabetes Undergoing Hemodialysis (ALPHA-2 Study). Diabetes Technol Ther. 2025 May;27(5):402-406. doi: 10.1089/dia.2024.0575. Epub 2025 Feb 5.
- Individual participant dataSharing planned: No
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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.
Nick Oliver principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G6 and Abbott Freestyle Libre in people with Diabetic Nephropathies and Type 1 Diabetes Mellitus, run by Imperial College London at 1 site in United Kingdom.
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 3 inclusion and 7 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 5 Aug 2022. 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 Kingdom. 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.
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?
MARD between G6 and YSI (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT03885362, which also lists 12 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 5 Aug 2022.