Assess the Impact of Insulclock on Glycemic Variability and Treatment Compliance in Uncontrolled DM1 Patients
NCT ID: NCT04847778
Last Updated: 2022-03-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
80 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-03-01
Study Completion Date
2021-07-31
Brief Summary
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Insulclock® is a small electronic device developed to facilitate the optimal administration of insulin. This device works as an add-on module of commercially available insulin pens and monitors the date, time and dose of injections, the type of insulin injected, the duration of injections and insulin temperature. The Insulclock 360 app allows automatic data logging, report generation and reminder setting, among other functions. In this study, we pretend to show the clinical impact of Insulclock system, both device and mobile application, on glycemic indices, treatment compliance, and quality of life in patients with persistent poorly controlled T1DM.
Material and methods: Randomized open-label multicenter controlled trial to evaluate glycemic control, the number of missed and delayed insulin doses, and quality of life after seven weeks of Insulclock 360 use in participants with uncontrolled DM1. We will also compare these results between patients with or without receiving system reminders and alerts.
This study aims to assess the effect of Insulclock on glycemic control, treatment adherence, and quality of life. As a secondary objective, we will compare the study outcomes between participants in the Active and Masked Insulclock groups (i.e., with or without receiving alerts and reminders and accessing the app).
To assess glycemic control, we will measure HbA1C and glycemic indices. Glycemic variability indices will be monitored with the FreeStyle Libre™ and included glucose coefficient of variation (CV), standard deviation (SD), time in range (TIR), time above range (TAR), and time below range (TBR). Mean glucose levels will be obtained from 48-h time intervals with the FreeStyle Libre.
A late meal bolus (mistimed) will be considered when Insulclock detects the injection at least 30 minutes after the CGM rise. To identify meal glucose excursions, we will use the Glucose Rate Increase Detector (GRID) algorithm, which estimates the rate of change (ROC) of glucose from CGM data.
Participants will complete the ITSQ and the DTSQ, which are validated questionnaires to assess the diabetes treatment satisfaction.
Material and methods: Randomized open-label multicenter controlled trial to evaluate glycemic control, the number of missed and delayed insulin doses, and quality of life after seven weeks of Insulclock 360 use in participants with uncontrolled DM1. We will also compare these results between patients with or without receiving system reminders and alerts.
This study aims to assess the effect of Insulclock on glycemic control, treatment adherence, and quality of life. As a secondary objective, we will compare the study outcomes between participants in the Active and Masked Insulclock groups (i.e., with or without receiving alerts and reminders and accessing the app).
To assess glycemic control, we will measure HbA1C and glycemic indices. Glycemic variability indices will be monitored with the FreeStyle Libre™ and included glucose coefficient of variation (CV), standard deviation (SD), time in range (TIR), time above range (TAR), and time below range (TBR). Mean glucose levels will be obtained from 48-h time intervals with the FreeStyle Libre.
A late meal bolus (mistimed) will be considered when Insulclock detects the injection at least 30 minutes after the CGM rise. To identify meal glucose excursions, we will use the Glucose Rate Increase Detector (GRID) algorithm, which estimates the rate of change (ROC) of glucose from CGM data.
Participants will complete the ITSQ and the DTSQ, which are validated questionnaires to assess the diabetes treatment satisfaction.
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Detailed Description
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Study design:
This multicentric randomized open-label study will be conducted at the Hospital General de Segovia (Segovia, Spain), Hospital de Cruces (Bilbao, Spain), Hospital Arquitecto Marcide (Ferrol, A Coruña, Spain) and Hospital Central de Asturias (Oviedo, Spain) after classification by the Spanish Agency for Medicines and Health Products (AEMPS) and ethical approval by the Ethics Review Committee of each research center. The study will be conducted in compliance with the ethical principles of the Declaration of Helsinki. Each participant will provide written informed consent before being included in the study.
The study is scheduled across seven visits. At Visit 1 (Screening, Week -1), demographic and clinical information will be collected, and concomitant medications will be registered. All potential study patients will be screened for eligibility after signing the informed consent form (ICF) and will be assigned with a patient identification number. Laboratory evaluations (HbA1c, serum chemistry) must be available within the last 2 months. An identification number will be assigned to each participant At Visit 2 (Run-in, week 0), participants will receive information on the use of the Insulclock device and app on masked mode (excluding the use of Insulclock 360 app information and alarms). If the participant does not use a CGM: a healthcare professional applies the FreeStyle Libre sensor to the back of the upper arm and activates it. If the participant already uses a CGM system, the patient will be encouraged to use sensors during this period.
At Visit 3 (First Visit CGM 1, week 1) and Visit 4 (Follow-up, week 3), participants will be encouraged to use the system At Visit 5 (Visit Starting CGM 2 and Randomization, week 4) participants will be randomized (1:1) to the Active Insulclock group or the Masked Insulclock group. Participants randomized in the Insulclock Active Group will receive detailed instructions on using the Insulclock device and Insulclock 360 mobile application and will be instructed and motivated for full use of all system functions (alarms, messages to the caregivers and investigation team). Participants randomized in the Insulclock Masked Group will be instructed on the correct installation and use of the Insulclock system for recording insulin bolus information but they will not receive any other information and will not have access to the Insulclock 360 application from the Internet and will keep administering insulin treatment as before. A healthcare professional will apply a FreeStyle Libre sensor to the upper arm in all the participants who do not use a CGM and will be encouraged to wear the sensor for 2 weeks. Participants who already use a CGM system will be encouraged to use sensors during this period.
At Visit 6 (Final Visit CGM 2 and Randomization, week 6). Participants will receive a reminder on the use of Insulclock according to the corresponding group.
At Visit 7 (Final Visit, week 7) the mobile application diaries will be collected and reviewed. Participants will receive to fill in the Insulin Treatment Satisfaction Questionnaire (ITSQ) and the Diabetes Treatment Questionnaire (DTSQ).
Study population Investigators will include 80 participants aged 18-80 years with uncontrolled T1DM who provide written informed consent. Persistent uncontrolled T1DM was defined as HbA1C levels ≥6.5% for at least 1 year, and/or variations ≥1% in HbA1C within the previous 2 years and attending regular (more than 2 per year) follow-up visits at the Endocrinology department. Investigators will exclude pregnant or breastfeeding women, individuals with a history of or current alcohol or drug abuse, acute infection, cognitive decline or dementia, or any illness or condition that could interfere with the trial.
Study devices:
Insulclock is a small electronic device that works as an add-on module of insulin pens. This device can record the dose and time of insulin injected, register temperature changes of insulin pens, record the duration of an injection, and the specific insulin pen used. In the present study, participants self-administer insulin with pens coupled to Insulclock and according to routine clinical practice. By means of acoustic and visual alarms, participants receive information for a correct injection technique (an alert if the injection time was \<6 seconds) or to prevent stacking insulin (an alert if a previous injection was done within the 2 previous hours).
The Insulclock device is synchronized with the Insulclock 360 app for the automatic logging of patient data. The Insulclock 360 app also has a reminder function to promote the timely administration of insulin doses. Users can also receive customized tips on DM management with the "my tutors" tool and obtain information on DM topics. Insulclock 360 app is compatible with Apple and Android operating systems.
In the Active group, participants will receive acoustic and visual alarms, device-related information and will have access to the Insulclock 360 app. In the Masked group, participants know the dose, time and duration of injections, but these participants will not receive any reminder and will be masked to the Insulclock 360 app.
Participants will use the Freestyle Libre (Abbott Diabetes Care, Witney, Oxon, UK) for the continuous monitoring of glucose levels. This flash continuous monitoring system is to be worn on the upper arm and does not require capillary glucose concentrations for calibration. The sensor automatically records glucose data every 15 minutes for 14 days.
Statistical Analysis The proposed statistical analysis methods constitute a synthesis of the methods to be used in this study to apply them to the data collected and respond to the general objective and the specific objectives.
Data from all participants included in the study, who meet the selection criteria, will be analyzed. Data in absentia will not be charged and will be considered as lost.
A general description of the variables included in the study will be made. The absolute and relative frequency distributions of the qualitative variables will be presented by investigators, as well as the measures of central tendency and dispersion (mean, standard deviation, median, minimum and maximum) of the quantitative variables. The confidence intervals will be presented at 95% for the main quantitative outcome variables associated with the main objective and the main secondary variables.
The data corresponding to the variables included in the main objective will be descriptively analyzed.
Investigators will use the SPSS software Version 17.0. to perform the analysis. The hypothesis tests that are carried out will be in all bilateral cases and with a significance level of 0.05. For variables that do not fit the normal distribution(or parametric), the Mann Whitney hypothesis tests will be used (for unpaired data). The chi-square test (or Fischer's exact test when appropriate) will be used for the analysis of contingency tables as well as for the comparison of proportions and/or frequency distributions.
This multicentric randomized open-label study will be conducted at the Hospital General de Segovia (Segovia, Spain), Hospital de Cruces (Bilbao, Spain), Hospital Arquitecto Marcide (Ferrol, A Coruña, Spain) and Hospital Central de Asturias (Oviedo, Spain) after classification by the Spanish Agency for Medicines and Health Products (AEMPS) and ethical approval by the Ethics Review Committee of each research center. The study will be conducted in compliance with the ethical principles of the Declaration of Helsinki. Each participant will provide written informed consent before being included in the study.
The study is scheduled across seven visits. At Visit 1 (Screening, Week -1), demographic and clinical information will be collected, and concomitant medications will be registered. All potential study patients will be screened for eligibility after signing the informed consent form (ICF) and will be assigned with a patient identification number. Laboratory evaluations (HbA1c, serum chemistry) must be available within the last 2 months. An identification number will be assigned to each participant At Visit 2 (Run-in, week 0), participants will receive information on the use of the Insulclock device and app on masked mode (excluding the use of Insulclock 360 app information and alarms). If the participant does not use a CGM: a healthcare professional applies the FreeStyle Libre sensor to the back of the upper arm and activates it. If the participant already uses a CGM system, the patient will be encouraged to use sensors during this period.
At Visit 3 (First Visit CGM 1, week 1) and Visit 4 (Follow-up, week 3), participants will be encouraged to use the system At Visit 5 (Visit Starting CGM 2 and Randomization, week 4) participants will be randomized (1:1) to the Active Insulclock group or the Masked Insulclock group. Participants randomized in the Insulclock Active Group will receive detailed instructions on using the Insulclock device and Insulclock 360 mobile application and will be instructed and motivated for full use of all system functions (alarms, messages to the caregivers and investigation team). Participants randomized in the Insulclock Masked Group will be instructed on the correct installation and use of the Insulclock system for recording insulin bolus information but they will not receive any other information and will not have access to the Insulclock 360 application from the Internet and will keep administering insulin treatment as before. A healthcare professional will apply a FreeStyle Libre sensor to the upper arm in all the participants who do not use a CGM and will be encouraged to wear the sensor for 2 weeks. Participants who already use a CGM system will be encouraged to use sensors during this period.
At Visit 6 (Final Visit CGM 2 and Randomization, week 6). Participants will receive a reminder on the use of Insulclock according to the corresponding group.
At Visit 7 (Final Visit, week 7) the mobile application diaries will be collected and reviewed. Participants will receive to fill in the Insulin Treatment Satisfaction Questionnaire (ITSQ) and the Diabetes Treatment Questionnaire (DTSQ).
Study population Investigators will include 80 participants aged 18-80 years with uncontrolled T1DM who provide written informed consent. Persistent uncontrolled T1DM was defined as HbA1C levels ≥6.5% for at least 1 year, and/or variations ≥1% in HbA1C within the previous 2 years and attending regular (more than 2 per year) follow-up visits at the Endocrinology department. Investigators will exclude pregnant or breastfeeding women, individuals with a history of or current alcohol or drug abuse, acute infection, cognitive decline or dementia, or any illness or condition that could interfere with the trial.
Study devices:
Insulclock is a small electronic device that works as an add-on module of insulin pens. This device can record the dose and time of insulin injected, register temperature changes of insulin pens, record the duration of an injection, and the specific insulin pen used. In the present study, participants self-administer insulin with pens coupled to Insulclock and according to routine clinical practice. By means of acoustic and visual alarms, participants receive information for a correct injection technique (an alert if the injection time was \<6 seconds) or to prevent stacking insulin (an alert if a previous injection was done within the 2 previous hours).
The Insulclock device is synchronized with the Insulclock 360 app for the automatic logging of patient data. The Insulclock 360 app also has a reminder function to promote the timely administration of insulin doses. Users can also receive customized tips on DM management with the "my tutors" tool and obtain information on DM topics. Insulclock 360 app is compatible with Apple and Android operating systems.
In the Active group, participants will receive acoustic and visual alarms, device-related information and will have access to the Insulclock 360 app. In the Masked group, participants know the dose, time and duration of injections, but these participants will not receive any reminder and will be masked to the Insulclock 360 app.
Participants will use the Freestyle Libre (Abbott Diabetes Care, Witney, Oxon, UK) for the continuous monitoring of glucose levels. This flash continuous monitoring system is to be worn on the upper arm and does not require capillary glucose concentrations for calibration. The sensor automatically records glucose data every 15 minutes for 14 days.
Statistical Analysis The proposed statistical analysis methods constitute a synthesis of the methods to be used in this study to apply them to the data collected and respond to the general objective and the specific objectives.
Data from all participants included in the study, who meet the selection criteria, will be analyzed. Data in absentia will not be charged and will be considered as lost.
A general description of the variables included in the study will be made. The absolute and relative frequency distributions of the qualitative variables will be presented by investigators, as well as the measures of central tendency and dispersion (mean, standard deviation, median, minimum and maximum) of the quantitative variables. The confidence intervals will be presented at 95% for the main quantitative outcome variables associated with the main objective and the main secondary variables.
The data corresponding to the variables included in the main objective will be descriptively analyzed.
Investigators will use the SPSS software Version 17.0. to perform the analysis. The hypothesis tests that are carried out will be in all bilateral cases and with a significance level of 0.05. For variables that do not fit the normal distribution(or parametric), the Mann Whitney hypothesis tests will be used (for unpaired data). The chi-square test (or Fischer's exact test when appropriate) will be used for the analysis of contingency tables as well as for the comparison of proportions and/or frequency distributions.
Conditions
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Diabetes Mellitus, Type 1
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
All participants will start the study using Insulclock, device and app on Masked Mode. At the week 4 patients will be randomized (1:1) to the Active Insulclock group or the Masked Insulclock group. Patients randomized in the Insulclock Active Group will receive detailed instructions on using the Insulclock device and Insulclock 360 mobile application and will be instructed and motivated for full use of all system functions (alarms, messages to the caregivers and investigation team). Patients randomized in the Insulclock Masked Group will be instructed on the correct installation and use of the Insulclock system for recording insulin bolus information but they will not receive any other information and will not have access to the Insulclock 360 application from the Internet and will keep administering insulin treatment as before. A healthcare professional will apply a FreeStyle Libre sensor to the upper arm in all the participants who do not use a CGM.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Participants
* Patients will be instructed on the correct installation and use of the Insulclock 360 system for recording insulin bolus information.
* Patients do not receive any other information and will not have access to the Insulclock 360 application from the Internet.
* They will keep administering insulin treatment as before.
* Randomization is blind to the recruiting investigator.
* Patients do not receive any other information and will not have access to the Insulclock 360 application from the Internet.
* They will keep administering insulin treatment as before.
* Randomization is blind to the recruiting investigator.
Study Groups
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Masked arm
* Participants will be instructed on the correct installation and use of the Insulclock device and app on masked mode for recording insulin bolus information.
* Participants do not receive any other information and will not have access to the Insulclock 360 application from the Internet.
* Participants will keep administering insulin treatment as usual.
Group Type
ACTIVE_COMPARATOR
Use of Insulclock system, both Insulclock device and Insulclock app on masked mode.
Intervention Type
DEVICE
Visit 5, during week 4.
Randomization will be applied:
Masked group will remain with the masked system, without functionalities.
Active arm
* Participants will receive detailed instructions on using the Insuclock 360 app and Insulclock device
* Participants will be instructed and motivated for full use of all system functions: alarms, messages to the caregivers and investigation team.
Group Type
ACTIVE_COMPARATOR
Use of Insulclock system, both Insulclock device and Insulclock 360 app.
Intervention Type
DEVICE
Visit 5, during week 4.
Randomization will be applied:
Active group will use all functionalities of Insulclock 360. They will have reminders, all their information and statistics at the disposition of the patient and healthcare providers, they have the assistance if desired of an ally or caregiver, a bolus calculator and the rest of functionalities described in the protocol.
Use of Insulclock system, both Insulclock device and Insulclock app on masked mode.
Intervention Type
DEVICE
Visit 5, during week 4.
Randomization will be applied:
Masked group will remain with the masked system, without functionalities.
Interventions
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Use of Insulclock system, both Insulclock device and Insulclock 360 app.
Visit 5, during week 4.
Randomization will be applied:
Active group will use all functionalities of Insulclock 360. They will have reminders, all their information and statistics at the disposition of the patient and healthcare providers, they have the assistance if desired of an ally or caregiver, a bolus calculator and the rest of functionalities described in the protocol.
Intervention Type
DEVICE
Use of Insulclock system, both Insulclock device and Insulclock app on masked mode.
Visit 5, during week 4.
Randomization will be applied:
Masked group will remain with the masked system, without functionalities.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
1. age range: 14 to 80 years
2. DM1 diagnosed
3. Patients with type 1 diabetes and poor glycemic control, defined as:
* HbA1c ≥ 6.5% during more than a year
* and/or extreme variations (more than 1% of change in HbA1c in the last 2 years)
* and regular visits to the Endocrinology Unit / Diabetes Unit (more than four each year).
4. Signed informed consent form
5. Ability of the subjects to use the system and fill the included questionnaires
6. Ability and willingness of following and be compatible with the protocol of the clinical trial
2. DM1 diagnosed
3. Patients with type 1 diabetes and poor glycemic control, defined as:
* HbA1c ≥ 6.5% during more than a year
* and/or extreme variations (more than 1% of change in HbA1c in the last 2 years)
* and regular visits to the Endocrinology Unit / Diabetes Unit (more than four each year).
4. Signed informed consent form
5. Ability of the subjects to use the system and fill the included questionnaires
6. Ability and willingness of following and be compatible with the protocol of the clinical trial
Exclusion Criteria
1. Rejection or inability to give the informed consent to participate in the trial.
2. Pregnancy or lactation
3. Addiction or abuse of alcohol, or history of drug abuse in the last years
4. Dementia diagnosis
5. Acute infection
6. Any illness or condition that, according to investigator, could interfere with the trial
2. Pregnancy or lactation
3. Addiction or abuse of alcohol, or history of drug abuse in the last years
4. Dementia diagnosis
5. Acute infection
6. Any illness or condition that, according to investigator, could interfere with the trial
Minimum Eligible Age
14 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Insulcloud S.L.
INDUSTRY
Sponsor Role
collaborator
Hospital General de Segovia
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Fernando Gomez Peralta, Physician
Role: PRINCIPAL_INVESTIGATOR
Hospital General de Segovia, Segovia, Spain
Locations
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Endocrinology and Nutrition Unit, Arquitecto Marcide Hospital
Ferrol, A Coruña, Spain
Site Status
Endocrinology and Nutrition Service, Hospital de Cruces.
Bilbao, , Spain
Site Status
Endocrinology and Nutrition Service, Hospital Central de Asturias
Oviedo, , Spain
Site Status
Endocrinology and Nutrition Unit /Diabetes Unit, Hospital General de Segovia
Segovia, , Spain
Site Status
Countries
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Spain
References
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Soriguer F, Goday A, Bosch-Comas A, Bordiu E, Calle-Pascual A, Carmena R, Casamitjana R, Castano L, Castell C, Catala M, Delgado E, Franch J, Gaztambide S, Girbes J, Gomis R, Gutierrez G, Lopez-Alba A, Martinez-Larrad MT, Menendez E, Mora-Peces I, Ortega E, Pascual-Manich G, Rojo-Martinez G, Serrano-Rios M, Valdes S, Vazquez JA, Vendrell J. Prevalence of diabetes mellitus and impaired glucose regulation in Spain: the [email protected] Study. Diabetologia. 2012 Jan;55(1):88-93. doi: 10.1007/s00125-011-2336-9. Epub 2011 Oct 11.
Reference Type
BACKGROUND
American Diabetes Association. 7. Approaches to Glycemic Treatment. Diabetes Care. 2016 Jan;39 Suppl 1:S52-9. doi: 10.2337/dc16-S010. No abstract available.
Reference Type
BACKGROUND
Borschuk AP, Everhart RS. Health disparities among youth with type 1 diabetes: A systematic review of the current literature. Fam Syst Health. 2015 Sep;33(3):297-313. doi: 10.1037/fsh0000134. Epub 2015 May 18.
Reference Type
BACKGROUND
Martyn-Nemeth P, Schwarz Farabi S, Mihailescu D, Nemeth J, Quinn L. Fear of hypoglycemia in adults with type 1 diabetes: impact of therapeutic advances and strategies for prevention - a review. J Diabetes Complications. 2016 Jan-Feb;30(1):167-77. doi: 10.1016/j.jdiacomp.2015.09.003. Epub 2015 Sep 7.
Reference Type
BACKGROUND
Stolpe S, Kroes MA, Webb N, Wisniewski T. A Systematic Review of Insulin Adherence Measures in Patients with Diabetes. J Manag Care Spec Pharm. 2016 Nov;22(11):1224-1246. doi: 10.18553/jmcp.2016.22.11.1224.
Reference Type
BACKGROUND
Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care. 2010 Feb;33(2):240-5. doi: 10.2337/dc09-1348.
Reference Type
BACKGROUND
Celik S, Cosansu G, Erdogan S, Kahraman A, Isik S, Bayrak G, Bektas B, Olgun N. Using mobile phone text messages to improve insulin injection technique and glycaemic control in patients with diabetes mellitus: a multi-centre study in Turkey. J Clin Nurs. 2015 Jun;24(11-12):1525-33. doi: 10.1111/jocn.12731. Epub 2014 Nov 25.
Reference Type
BACKGROUND
Arsand E, Muzny M, Bradway M, Muzik J, Hartvigsen G. Performance of the first combined smartwatch and smartphone diabetes diary application study. J Diabetes Sci Technol. 2015 May;9(3):556-63. doi: 10.1177/1932296814567708. Epub 2015 Jan 14.
Reference Type
BACKGROUND
Klausmann G, Hramiak I, Qvist M, Mikkelsen KH, Guo X. Evaluation of preference for a novel durable insulin pen with memory function among patients with diabetes and health care professionals. Patient Prefer Adherence. 2013 Apr 5;7:285-92. doi: 10.2147/PPA.S41929. Print 2013.
Reference Type
BACKGROUND
Guo X, Sommavilla B, Vanterpool G, Qvist M, Bethien M, Lilleore SK. Evaluation of a new durable insulin pen with memory function among people with diabetes and healthcare professionals. Expert Opin Drug Deliv. 2012 Apr;9(4):355-6. doi: 10.1517/17425247.2012.671808.
Reference Type
BACKGROUND
Danne T, Forst T, Deinhard J, Rose L, Moennig E, Haupt A. No effect of insulin pen with memory function on glycemic control in a patient cohort with poorly controlled type 1 diabetes: a randomized open-label study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1392-7. doi: 10.1177/193229681200600619.
Reference Type
BACKGROUND
Burdick J, Chase HP, Slover RH, Knievel K, Scrimgeour L, Maniatis AK, Klingensmith GJ. Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy. Pediatrics. 2004 Mar;113(3 Pt 1):e221-4. doi: 10.1542/peds.113.3.e221.
Reference Type
BACKGROUND
Diabetes 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.
Reference Type
BACKGROUND
Phan TL, Hossain J, Lawless S, Werk LN. Quarterly visits with glycated hemoglobin monitoring: the sweet spot for glycemic control in youth with type 1 diabetes. Diabetes Care. 2014 Feb;37(2):341-5. doi: 10.2337/dc13-0980. Epub 2013 Sep 23.
Reference Type
BACKGROUND
Luo M, Tan KHX, Tan CS, Lim WY, Tai ES, Venkataraman K. Longitudinal trends in HbA1c patterns and association with outcomes: A systematic review. Diabetes Metab Res Rev. 2018 Sep;34(6):e3015. doi: 10.1002/dmrr.3015. Epub 2018 May 22.
Reference Type
BACKGROUND
Gomez-Peralta F, Abreu C, Gomez-Rodriguez S, Ruiz L. Insulclock: A Novel Insulin Delivery Optimization and Tracking System. Diabetes Technol Ther. 2019 Apr;21(4):209-214. doi: 10.1089/dia.2018.0361. Epub 2019 Mar 21.
Reference Type
BACKGROUND
Gomez-Peralta F, Abreu C, Gomez-Rodriguez S, Cruz-Bravo M, Maria-Sanchez C, Poza G, Ruiz-Valdepenas L. Efficacy of Insulclock in Patients with Poorly Controlled Type 1 Diabetes Mellitus: A Pilot, Randomized Clinical Trial. Diabetes Technol Ther. 2020 Sep;22(9):686-690. doi: 10.1089/dia.2019.0427. Epub 2020 Mar 5.
Reference Type
BACKGROUND
Ruiz-Ramos M, Escolar-Pujolar A, Mayoral-Sanchez E, Corral-San Laureano F, Fernandez-Fernandez I. [Diabetes mellitus in Spain: death rates, prevalence, impact, costs and inequalities]. Gac Sanit. 2006 Mar;20 Suppl 1:15-24. doi: 10.1157/13086022. Spanish.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Related Links
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https://www.insulcloud.com/
Homepage of the Insuclock device and Insulclock 360 app
Other Identifiers
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INSULCLOCK2018
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE1
Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
NCT04476472
COMPLETED
NA
Pivotal Omnipod Horizon™ Automated Glucose Control System
NCT04196140
COMPLETED
NA
A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar
NCT07160816
RECRUITING
Efficacy of Closed-loop Insulin Therapy in Adults Prone to Hypoglycemia
NCT04266379
UNKNOWN
NA
Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia
NCT02411578
COMPLETED
PHASE2
Hybrid Closed Loop Insulin Delivery System in Hypoglycemia
NCT03215914
COMPLETED
NA
Prepivotal Omnipod Horizon™ Automated Glucose Control System
NCT04176731
COMPLETED
NA
Insulin Degludec Titration Using Mobile Insulin Dosing System
NCT03091712
COMPLETED
NA
A Study of LY900014 in a Medtronic Pump
NCT03760640
COMPLETED
PHASE2
A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump
NCT03056456
COMPLETED
PHASE1
Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes
NCT06021145
RECRUITING
PHASE4
Clinical Study: Analysis of Glycemic Control and Satisfaction With a Connected Smart Cap in Patients With Type 1 Diabetes Mellitus
NCT06845891
COMPLETED
PHASE4
SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c
NCT00598663
COMPLETED
NA
A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus
NCT04161976
COMPLETED
PHASE1
The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France.
NCT04308291
COMPLETED
My Dose Coach Mobile App to Support Insulin Titration and Maintenance
NCT04678661
TERMINATED
NA
Obtain a Good Blood Glucose Control With the Paradigm Real Time System
NCT00441129
COMPLETED
NA
A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens
NCT05036343
COMPLETED
NA