Type 1 DiabetesAID-CompNCT05477030
Effect of Automated Insulin Delivery on Early-stage Diabetic Complications
A study testing Medtronic MiniMed 780G with SmartGuard activation and Medtronic MiniMed 780G without SmartGuard activation in people with Type 1 Diabetes, run by University of Milan at 1 site in Italy.
Trial summary
Aim of this study is to verify the effects of an advanced HCL (Medtronic Minimed™ 780G) compared to SAP with PLGS on metabolic outcomes and markers of early microvascular damage in a population of adults with T1D previously treated with CSII. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Medtronic MiniMed 780G with SmartGuard activation and Medtronic MiniMed 780G without SmartGuard activation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 23 Feb 2022to 23 Feb 2024
- 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
- Male and female patients
- T1D patients above 18 years in CSII treatment for at least 3 months
- HbA1c values between 6.0% and 9.5%
- Disease duration ≥ 2 years
- Written informed consent obtained from the patient
Who cannot join
- Pregnancy
- Participation to other clinical trials
- A history of alcohol or drug abuse
- Advanced diabetic nephropathy defined as presence of albuminuria ≥ 300 mg/g or eGFR < 60 ml/min/1,73m2
- Proliferative Diabetic retinopathy or macular edema
- Established Atherosclerotic Cardiovascular Disease (ASCVD) or history of heart failure
Show all 9Show fewer
- Presence of serious diseases or conditions which in the opinion of the Investigator makes patient non-eligible for the study
- Hypoglycemia Unawareness (Clarke score > 4)
- Patients unable to understand spoken and written Italian language
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASST FBF Sacco
Milan, 20157
Elio Ippolito, Dr., 02 39042648, ippolito.elio@asst-fbf-sacco.it
Paolo Fiorina, MD, PhD
About this study
Official title: Effect of Automated Insulin Delivery With Advanced Closed-loop on Glucose Outcomes and Early-stage Diabetic Complications
Aim of this study is to verify the effects of an advanced HCL (Medtronic Minimed™ 780G) compared to SAP with PLGS on metabolic outcomes and markers of early microvascular damage in a population of adults with T1D previously treated with CSII. Evaluation of endothelial disfunction and autonomic neuropathy will also be performed.
Read the detailed description
New algorithms for the automation of insulin delivery (AID) are showing great benefit on glucose control in people with type 1 diabetes. Indeed, Hybrid closed loop (HCL) systems can improve HbA1c levels, percentage of time in defined glucose range, time below range and time over range, according to RCT and observational studies results. However, scientific evidences demonstrating potential benefits on the reduction of diabetes complications are limited regarding CSII or SAP with demonstrated reduction of cardiovascular mortality, improvement of albuminuria and peripheral nerve damage.
Data on AID effects on complications of diabetes are missing. In this study intermediate damage markers will be measured to assess potential effects of AID in comparison to sensor augmented pumps.
- Conditions
- Type 1 Diabetes
- Being tested
- Medtronic MiniMed 780G with SmartGuard activation, Medtronic MiniMed 780G without SmartGuard activation
- Keywords
- Automated insulin delivery, Type 1 Diabetes complications
- 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.
Medtronic MiniMed 780G with SmartGuard activationDevice
Insulin pump implemented with alghoritm for automatic modulation of insulin delivery (to increase time in glucose range 70-180 mg/dl)
Medtronic MiniMed 780G without SmartGuard activationDevice
Insulin pump implemented with alghoritm for low glucose insulin suspension (to reduce hypoglycemia rate)
| Study group | Role | What they receive |
|---|---|---|
| Study Group A (Intervention) | Active comparator | Group treated with automated insulin delivery (advanced hybrid closed-loop) Receives: Device: Medtronic MiniMed 780G with SmartGuard activation |
| Study Group B (Control) | Active comparator | Group treated with predictive low glucose suspend (sensor augmented pump - PLGS) Receives: Device: Medtronic MiniMed 780G without SmartGuard activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in glycemic range 70-180 mg/dl
time spent by the patient in glucose range
Measured: From Baseline to 26 weeks
Glycated Hemoglobin (HbA1c)
percentage of hemoglobin glycosylated
Measured: From Baseline to 26 weeks
Secondary outcomes (7)
Early microangiopathic damage markers: sTNFR-1/2
sTNFR-1/2 (pg/ml)
Measured: From Baseline to 26 weeks
Early microangiopathic damage markers: B-2 microglobulin
B-2 microglobulin (pg/ml)
Measured: From Baseline to 26 weeks
Early microangiopathic damage markers: cystatin C
cystatin C (ng/ml)
Measured: From Baseline to 26 weeks
Early microangiopathic damage markers: neutrophil gelatinase-associated lipocalin
neutrophil gelatinase-associated lipocalin (ng/ml)
Measured: From Baseline to 26 weeks
Early microangiopathic damage markers: osteopontin
osteopontin (pg/ml)
Measured: From Baseline to 26 weeks
Early microangiopathic damage markers: vWF levels
vWF levels (ng/ml)
Measured: From Baseline to 26 weeks
Endothelial disfunction
Endothelial-dependent dilation (EDD) is considered a marker of dysfunctional abnormalities involved in early phases of atherosclerosis development. Changes in EDD precede structural changes and occurs in the preclinical phase of vascular disease.
In the present study endothelial dependent dilation is assessed by color Doppler evaluation of flow increase after hyperemia.
Measured: From Baseline to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start23 Feb 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion23 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Fiorina, MD, University of Milan
- Investigators
- Paolo Fiorina, MD, PhD, Principal investigator, ASST-FBF-Sacco, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477030
- Sponsor's protocol ID
- 2022004
- Acronym
- AID-Comp
- Status last verified
- Jul 2022
- First submitted
- 16 Jun 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8366922Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus. JAMA. 2002 May 15;287(19):2563-9. doi: 10.1001/jama.287.19.2563.
PubMed 12020338Nathan 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 16371630Pettus JH, Zhou FL, Shepherd L, Preblick R, Hunt PR, Paranjape S, Miller KM, Edelman SV. Incidences of Severe Hypoglycemia and Diabetic Ketoacidosis and Prevalence of Microvascular Complications Stratified by Age and Glycemic Control in U.S. Adult Patients With Type 1 Diabetes: A Real-World Study. Diabetes Care. 2019 Dec;42(12):2220-2227. doi: 10.2337/dc19-0830. Epub 2019 Sep 23.
PubMed 31548241Pickup JC, Sutton AJ. Severe hypoglycaemia and glycaemic control in Type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diabet Med. 2008 Jul;25(7):765-74. doi: 10.1111/j.1464-5491.2008.02486.x.
PubMed 18644063Pankowska E, Blazik M, Dziechciarz P, Szypowska A, Szajewska H. Continuous subcutaneous insulin infusion vs. multiple daily injections in children with type 1 diabetes: a systematic review and meta-analysis of randomized control trials. Pediatr Diabetes. 2009 Feb;10(1):52-8. doi: 10.1111/j.1399-5448.2008.00440.x. Epub 2008 Aug 27.
PubMed 18761648EQuality1 Study Group--Evaluation of QUALITY of Life and Costs in Diabetes Type 1; Nicolucci A, Maione A, Franciosi M, Amoretti R, Busetto E, Capani F, Bruttomesso D, Di Bartolo P, Girelli A, Leonetti F, Morviducci L, Ponzi P, Vitacolonna E. Quality of life and treatment satisfaction in adults with Type 1 diabetes: a comparison between continuous subcutaneous insulin infusion and multiple daily injections. Diabet Med. 2008 Feb;25(2):213-20. doi: 10.1111/j.1464-5491.2007.02346.x. Epub 2008 Jan 14.
PubMed 18201210Maniatis AK, Toig SR, Klingensmith GJ, Fay-Itzkowitz E, Chase HP. Life with continuous subcutaneous insulin infusion (CSII) therapy: child and parental perspectives and predictors of metabolic control. Pediatr Diabetes. 2001 Jun;2(2):51-7. doi: 10.1034/j.1399-5448.2001.002002051.x.
PubMed 15016198Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Perkins BA, Welsh JB, Willi SM, Wood MA; STAR 3 Study Group. Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month continuation phase. Diabetes Care. 2011 Nov;34(11):2403-5. doi: 10.2337/dc11-1248. Epub 2011 Sep 20.
PubMed 21933908Forlenza GP, Li Z, Buckingham BA, Pinsker JE, Cengiz E, Wadwa RP, Ekhlaspour L, Church MM, Weinzimer SA, Jost E, Marcal T, Andre C, Carria L, Swanson V, Lum JW, Kollman C, Woodall W, Beck RW. Predictive Low-Glucose Suspend Reduces Hypoglycemia in Adults, Adolescents, and Children With Type 1 Diabetes in an At-Home Randomized Crossover Study: Results of the PROLOG Trial. Diabetes Care. 2018 Oct;41(10):2155-2161. doi: 10.2337/dc18-0771. Epub 2018 Aug 8.
PubMed 30089663Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.
PubMed 27629148Nimri R, Muller I, Atlas E, Miller S, Fogel A, Bratina N, Kordonouri O, Battelino T, Danne T, Phillip M. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014 Nov;37(11):3025-32. doi: 10.2337/dc14-0835. Epub 2014 Jul 30.
PubMed 25078901Garg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, Bailey TS, Brazg RL, Ilany J, Slover RH, Anderson SM, Bergenstal RM, Grosman B, Roy A, Cordero TL, Shin J, Lee SW, Kaufman FR. Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2017 Mar;19(3):155-163. doi: 10.1089/dia.2016.0421. Epub 2017 Jan 30.
PubMed 28134564Salehi P, Roberts AJ, Kim GJ. Efficacy and Safety of Real-Life Usage of MiniMed 670G Automode in Children with Type 1 Diabetes Less than 7 Years Old. Diabetes Technol Ther. 2019 Aug;21(8):448-451. doi: 10.1089/dia.2019.0123. Epub 2019 Jun 5.
PubMed 31166801Lepore G, Scaranna C, Corsi A, Dodesini AR, Trevisan R. Switching from Suspend-Before-Low Insulin Pump Technology to a Hybrid Closed-Loop System Improves Glucose Control and Reduces Glucose Variability: A Retrospective Observational Case-Control Study. Diabetes Technol Ther. 2020 Apr;22(4):321-325. doi: 10.1089/dia.2019.0302. Epub 2020 Feb 11.
PubMed 31617752
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Automated Insulin Delivery With Advanced Closed-loop on Glucose Outcomes and Early-stage Diabetic Complications
- ClinicalTrials.gov ID
- NCT05477030
- Acronym / sponsor ID
- AID-Comp / 2022004
- Conditions
- Type 1 Diabetes
- Keywords
- Automated insulin delivery, Type 1 Diabetes complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 23 Feb 2024 (estimated)
- First posted
- 28 Jul 2022 (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.
Aim of this study is to verify the effects of an advanced HCL (Medtronic Minimed™ 780G) compared to SAP with PLGS on metabolic outcomes and markers of early microvascular damage in a population of adults with T1D previously treated with CSII. Evaluation of endothelial disfunction and autonomic neuropathy will also be performed.
Detailed description
New algorithms for the automation of insulin delivery (AID) are showing great benefit on glucose control in people with type 1 diabetes. Indeed, Hybrid closed loop (HCL) systems can improve HbA1c levels, percentage of time in defined glucose range, time below range and time over range, according to RCT and observational studies results. However, scientific evidences demonstrating potential benefits on the reduction of diabetes complications are limited regarding CSII or SAP with demonstrated reduction of cardiovascular mortality, improvement of albuminuria and peripheral nerve damage.
Data on AID effects on complications of diabetes are missing. In this study intermediate damage markers will be measured to assess potential effects of AID in comparison to sensor augmented pumps.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Study Group A (Intervention) | Active comparator | Device: Medtronic MiniMed 780G with SmartGuard activationGroup treated with automated insulin delivery (advanced hybrid closed-loop) |
| Study Group B (Control) | Active comparator | Device: Medtronic MiniMed 780G without SmartGuard activationGroup treated with predictive low glucose suspend (sensor augmented pump - PLGS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients
- T1D patients above 18 years in CSII treatment for at least 3 months
- HbA1c values between 6.0% and 9.5%
- Disease duration ≥ 2 years
- Written informed consent obtained from the patient
Key exclusion criteria (9 listed)
- Pregnancy
- Participation to other clinical trials
- A history of alcohol or drug abuse
- Advanced diabetic nephropathy defined as presence of albuminuria ≥ 300 mg/g or eGFR < 60 ml/min/1,73m2
- Proliferative Diabetic retinopathy or macular edema
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 |
|---|---|---|
| Medtronic MiniMed 780G with SmartGuard activationInsulin pump implemented with alghoritm for automatic modulation of insulin delivery (to increase time in glucose range 70-180 mg/dl) | Device | Study Group A (Intervention) |
| Medtronic MiniMed 780G without SmartGuard activationInsulin pump implemented with alghoritm for low glucose insulin suspension (to reduce hypoglycemia rate) | Device | Study Group B (Control) |
Primary outcome
Time in glycemic range 70-180 mg/dl
Time frame: From Baseline to 26 weeks
time spent by the patient in glucose range
Glycated Hemoglobin (HbA1c)
Time frame: From Baseline to 26 weeks
percentage of hemoglobin glycosylated
7 secondary outcomes
Early microangiopathic damage markers: sTNFR-1/2
Time frame: From Baseline to 26 weeks
Early microangiopathic damage markers: B-2 microglobulin
Time frame: From Baseline to 26 weeks
Early microangiopathic damage markers: cystatin C
Time frame: From Baseline to 26 weeks
Early microangiopathic damage markers: neutrophil gelatinase-associated lipocalin
Time frame: From Baseline to 26 weeks
Early microangiopathic damage markers: osteopontin
Time frame: From Baseline to 26 weeks
Early microangiopathic damage markers: vWF levels
Time frame: From Baseline to 26 weeks
Endothelial disfunction
Time frame: From Baseline to 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Results publication: 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.
- Results publication: PubMed 12020338Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus. JAMA. 2002 May 15;287(19):2563-9. doi: 10.1001/jama.287.19.2563.
- Results publication: 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.
- Results publication: PubMed 31548241Pettus JH, Zhou FL, Shepherd L, Preblick R, Hunt PR, Paranjape S, Miller KM, Edelman SV. Incidences of Severe Hypoglycemia and Diabetic Ketoacidosis and Prevalence of Microvascular Complications Stratified by Age and Glycemic Control in U.S. Adult Patients With Type 1 Diabetes: A Real-World Study. Diabetes Care. 2019 Dec;42(12):2220-2227. doi: 10.2337/dc19-0830. Epub 2019 Sep 23.
- Results publication: PubMed 18644063Pickup JC, Sutton AJ. Severe hypoglycaemia and glycaemic control in Type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diabet Med. 2008 Jul;25(7):765-74. doi: 10.1111/j.1464-5491.2008.02486.x.
- Results publication: PubMed 18761648Pankowska E, Blazik M, Dziechciarz P, Szypowska A, Szajewska H. Continuous subcutaneous insulin infusion vs. multiple daily injections in children with type 1 diabetes: a systematic review and meta-analysis of randomized control trials. Pediatr Diabetes. 2009 Feb;10(1):52-8. doi: 10.1111/j.1399-5448.2008.00440.x. Epub 2008 Aug 27.
- Results publication: PubMed 18201210EQuality1 Study Group--Evaluation of QUALITY of Life and Costs in Diabetes Type 1; Nicolucci A, Maione A, Franciosi M, Amoretti R, Busetto E, Capani F, Bruttomesso D, Di Bartolo P, Girelli A, Leonetti F, Morviducci L, Ponzi P, Vitacolonna E. Quality of life and treatment satisfaction in adults with Type 1 diabetes: a comparison between continuous subcutaneous insulin infusion and multiple daily injections. Diabet Med. 2008 Feb;25(2):213-20. doi: 10.1111/j.1464-5491.2007.02346.x. Epub 2008 Jan 14.
- Results publication: PubMed 15016198Maniatis AK, Toig SR, Klingensmith GJ, Fay-Itzkowitz E, Chase HP. Life with continuous subcutaneous insulin infusion (CSII) therapy: child and parental perspectives and predictors of metabolic control. Pediatr Diabetes. 2001 Jun;2(2):51-7. doi: 10.1034/j.1399-5448.2001.002002051.x.
- Results publication: PubMed 21933908Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Perkins BA, Welsh JB, Willi SM, Wood MA; STAR 3 Study Group. Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month continuation phase. Diabetes Care. 2011 Nov;34(11):2403-5. doi: 10.2337/dc11-1248. Epub 2011 Sep 20.
- Results publication: PubMed 30089663Forlenza GP, Li Z, Buckingham BA, Pinsker JE, Cengiz E, Wadwa RP, Ekhlaspour L, Church MM, Weinzimer SA, Jost E, Marcal T, Andre C, Carria L, Swanson V, Lum JW, Kollman C, Woodall W, Beck RW. Predictive Low-Glucose Suspend Reduces Hypoglycemia in Adults, Adolescents, and Children With Type 1 Diabetes in an At-Home Randomized Crossover Study: Results of the PROLOG Trial. Diabetes Care. 2018 Oct;41(10):2155-2161. doi: 10.2337/dc18-0771. Epub 2018 Aug 8.
- Results publication: PubMed 27629148Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.
- Results publication: PubMed 25078901Nimri R, Muller I, Atlas E, Miller S, Fogel A, Bratina N, Kordonouri O, Battelino T, Danne T, Phillip M. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014 Nov;37(11):3025-32. doi: 10.2337/dc14-0835. Epub 2014 Jul 30.
- 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.
Paolo Fiorina, MD, PhD principal investigator
ASST-FBF-Sacco, University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic MiniMed 780G with SmartGuard activation and Medtronic MiniMed 780G without SmartGuard activation in people with Type 1 Diabetes, run by University of Milan at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 28 Jul 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elio Ippolito, MS (0239042648 ext. +39, elio.ippolito@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in glycemic range 70-180 mg/dl (time frame: From Baseline to 26 weeks). 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 NCT05477030, which also lists 25 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 28 Jul 2022.