DiabetesPhase 1/2NCT01557907
Multi-day (3) In-patient Evaluation of Intradermal Versus Subcutaneous Basal and Bolus Insulin Infusion
A Phase 1/2 study testing Subcutaneous delivery via Medtronic Quick-Set and Intradermal delivery via the BD Research Catheter Set in people with Diabetes, run by Becton, Dickinson and Company at 1 site in Germany.
Trial summary
The primary objective of this study is to investigate if intradermal (in the skin) basal and bolus insulin delivery of a fast acting insulin analog (NovoRapid) as needed to adequately control the blood glucose for a subject with Type 1 Diabetes can be maintained for a period of up to three days and if intradermal… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Subcutaneous delivery via Medtronic Quick-Set and Intradermal delivery via the BD Research Catheter Set
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to May 2012
- Phase
- Phase 1/2
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and Female patients will be included in the trial only if they fulfill all the inclusion criteria mentioned below:
- Understood and signed informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the patient)
- Type 1 Diabetes mellitus, according to clinical judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year.
- Usage of insulin pump therapy (CSII) with carb counting for at least six months
- Age in the range of ≥ 18 and ≤ 55 years
- Body mass index (BMI) ≤ 32 kg/m²
Show all 10Show fewer
- HbA1c ≤ 8.0% at screening
- Using ≤ than 60 U of insulin on a typical day (preferably)
- Able and willing to adhere to the study procedures for the entire trial period
- Negative test results for hepatitis C antibodies, hepatitis B surface antigen and HIV at screening.
Who cannot join
- Patients will not be permitted to enter the trial, if they fulfill any of the exclusion criteria mentioned below:
- Previous participation in this trial or participation in a clinical trial within 3 months prior to screening examination
- Any symptoms suggestive of, or a diagnosis or treatment for gastroparesis
- Abnormalities in renal function (e.g. serum creatinine > 120 µmmol/L for male, >100 µmmol/L for female subjects or judged by the investigator that would pose a problem of clearance of injected insulin
- Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
- Acute and severe illness apart from diabetes mellitus as judged by the investigator
Show all 20Show fewer
- Abnormalities in the laboratory parameters if judged as clinically significant by the investigator. In particular, patients with GOT/GPT > 3 x upper limit of normal (ULN), thrombocyte count <100/nL, INR >1.3, PTT >50 sec.
- Clinically significant abnormalities in the ECG
- Recurrent major hypoglycemia or hypoglycemic unawareness as judged by the investigator
- Lipodystrophy which in the judgment of the investigator would pose a problem in terms of variability of absorption of injected insulin
- Use of systemic corticoids for the last three month prior screening examination or treatment with medication known to interfere with glucose metabolism such as non-selective ß-blockers, or mono amine oxidase (MAO) inhibitors, ACE-inhibitors or thiazides, unless such medical treatment has existed for at least three months and is not changing, prior to screening examination
- Any disease requiring use of anti-coagulants
- Impaired hepatic or renal functions as judged by the investigator
- Cardiac problems as judged by the investigator
- Uncontrolled hypertension (treated or untreated) RRsyst. >140 mmHg, RRdiast. > 90 mmHg
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- Current addiction to alcohol or substances of abuse as determined by the investigator
- Allergy to plaster/adhesive
- Any other condition that the investigator feels would interfere with trial participation or evaluation of results.
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-day (3) In-patient Evaluation of Intradermal vs Subcutaneous Basal/Bolus Insulin Infusion
The primary objective of this study is to investigate if intradermal (in the skin) basal and bolus insulin delivery of a fast acting insulin analog (NovoRapid) as needed to adequately control the blood glucose for a subject with Type 1 Diabetes can be maintained for a period of up to three days and if intradermal delivery of insulin has advantages over standard subcutaneous (under the skin) delivery.
Read the detailed description
The is a single center, open-label, 2 period crossover study randomized by route (intradermal versus subcutaneous) in patients with Type 1 diabetes. Subjects will receive their insulin, basal and bolus dosages, via intradermal (ID) and subcutaneous (SC) infusion sets over a three day period.
Each subject will participate in 3 visits: a Screening Visit (V1), followed by 2 experimental intervention days (V2 and V3) to be started 2 - 21 days after screening visit. The minimum/maximum interval between study days shall be 5 to 28 days. Each subject will remain in the clinic for approximately 3 days during the experimental interventions. A final exam will be performed at the end of Visit 3.
After successful screening and enrollment subjects are admitted to the clinic. Their insulin pump and infusion set is replaced by the investigational system, a commercially available insulin pump and either the intradermal infusion set (Research Catheter Set, BD) or the subcutaneous infusion set (Quick Set, Medtronic)to include an in-line pressure transducer/recorder and insulin NovoRapid. The initial pump infusion rate is established based on the patient's known basal infusion rate and the meal bolus insulin is estimated based on the patient's known insulin sensitivity. An intravenous (in the vein) catheter line is established, blood glucose is measured at least every 2 hours overnight and insulin corrections can be implemented, if deemed necessary. The overnight and pre-prandial (before meal) target range is 70-160 mg/dl, although the procedure will continue as planned if the patient is outside the range. It should be the goal not to give any IV glucose or insulin at all, and not to change basal insulin settings for at least 2 hours before the meal. The breakfast meal will be a high GI (60g carbohydrates) solid meal, to be consumed within 15 minutes and followed for a period of 6 hours of blood sampling for glucose and insulin levels. Lunch will be served as standardized mixed meal, and followed for a period of 4-6 hours. This procedure is repeated on days 2 and 3 whereas the breakfast and lunch meal as well as the insulin dose to cover the meal are the same. A light evening dinner is served every day, composition and insulin dose to be recorded. On day three after the 4 hour period following lunch the catheter will be removed, catheter and site assessments will be documented and an ultrasound observation of the infusion site (skin thickness and SC) versus an adjacent control site will be performed within 10 min after removal of the infusion set. Glucose rescue, if necessary, will be administered orally (juice, 200 mL). Insulin correction boli should be delivered via the investigational infusion set.
- Conditions
- Diabetes
- Being tested
- Subcutaneous delivery via Medtronic Quick-Set, Intradermal delivery via the BD Research Catheter Set
- Keywords
- Diabetes, Diabetes Mellitus, Type 1 diabetes, Insulin Pump users, Intradermal insulin
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous delivery via Medtronic Quick-SetDevice
Also called insulin infusion set
Infusion rates and pre-meal bolus doses will be based on subjects known daily infusion rate and subject's reported insulin to carbohydrate ratio.
Intradermal delivery via the BD Research Catheter SetDevice
Also called microneedles, insulin infusion set
Infusion rates and pre-meal bolus doses will be based on subjects known daily infusion rate and subject's reported insulin to carbohydrate ratio.
| Study group | Role | What they receive |
|---|---|---|
| Intradermal - BD Research Catheter Set | Experimental | Intradermal delivery of insulin (basal and bolus delivery) using the BD Research Catheter Set with 34G x 1.5 mm side-ported needle and the Animas Vibe insulin pump over a three day period. Receives: Device: Intradermal delivery via the BD Research Catheter Set |
| Subcutaneous - Medtronic Quick-Set | Active comparator | Subcutaneous delivery of insulin (basal and bolus delivery) using the Medtronic Quick Set with 6 mm Teflon catheter and the Animas Vibe insulin pump over a three day period. Receives: Device: Subcutaneous delivery via Medtronic Quick-Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin levels
Time to peak plasma concentration (Tmax) of insulin delivered intradermally as compared to insulin delivered subcutaneously after a meal bolus.
Measured: 0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days
Secondary outcomes (8)
Insulin levels
Comparison of peak plasma concentration (Cmax) of insulin, intradermally versus subcutaneously, during a meal bolus period.
Comparison of area under the plasma concentration versus time curve (AUC), intradermally versus subcutanously, during a meal bolus period.
Measured: 0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days
Blood Glucose
Peak concentration of blood glucose (BGmax) during post meal excursions periods.
Area under the plasma concentration versus time curve (AUC) of blood glucose during post meal excurion periods.
Measured: 0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days
Device performance - adhesion
Adhesion (device remains attached to the skin) will be evaluated over the 3 day study period (adhered well, partially adhered, completely pulled off).
Measured: Evaluated at every timepoint a bolus injection is given
Skin thickness using ultrasound
Skin thickness will be measured at the infusion site and a control site using ultrasound
Measured: Upon removal of the device (within 5 minutes)
Device performance - Leakage of fluid (insulin) at injection site
Immediatley before and after each bolus injection, the site will be observed for leakage (insulin). In addition, following removal of the device, if leakakge is observed, the fluid will be collected and quantified using a gravimetic method procedure. Leakage will be collected using a pre-weighed sterile absorbent swab, the swab will be re-weighed and the collected fuid volume calculated based on the density of the fluid.
Measured: Immediatley before and after each bolus injection and immediatly upon removal of the device at the end of the study period.
Device performance-pump alarm
The presence of an auditory alarm indicating an occlusion will be noted.
Measured: over the 3 study days
Skin effects-Draize Scoring for Skin Irritation
Local reaction at injection site will be scored using the Draize Scale 0-4 for redness and 0-4 for swelling.
Measured: Following removal of the device (within 2 minutes) and 1 and 2 hours (+/- 5 minutes) post removal.
Number of participants with adverse events
At each study contact, subjects will be questioned about any new or worsening undesirable events.
Measured: up to 53 days or until the subject is discharged, if sooner.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Kapitza, MD, Principal investigator, Profil Institut fur Stoffwechselforschung (GmbH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557907
- Sponsor's protocol ID
- BDT-11-ADC001
- Status last verified
- Jul 2012
- First submitted
- 9 Mar 2012
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-day (3) In-patient Evaluation of Intradermal vs Subcutaneous Basal/Bolus Insulin Infusion
- ClinicalTrials.gov ID
- NCT01557907
- Acronym / sponsor ID
- BDT-11-ADC001
- Conditions
- Diabetes
- Keywords
- Diabetes, Diabetes Mellitus, Type 1 diabetes, Insulin Pump users, Intradermal insulin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Mar 2012 (estimated)
- 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 primary objective of this study is to investigate if intradermal (in the skin) basal and bolus insulin delivery of a fast acting insulin analog (NovoRapid) as needed to adequately control the blood glucose for a subject with Type 1 Diabetes can be maintained for a period of up to three days and if intradermal delivery of insulin has advantages over standard subcutaneous (under the skin) delivery.
Detailed description
The is a single center, open-label, 2 period crossover study randomized by route (intradermal versus subcutaneous) in patients with Type 1 diabetes. Subjects will receive their insulin, basal and bolus dosages, via intradermal (ID) and subcutaneous (SC) infusion sets over a three day period.
Each subject will participate in 3 visits: a Screening Visit (V1), followed by 2 experimental intervention days (V2 and V3) to be started 2 - 21 days after screening visit. The minimum/maximum interval between study days shall be 5 to 28 days. Each subject will remain in the clinic for approximately 3 days during the experimental interventions. A final exam will be performed at the end of Visit 3.
After successful screening and enrollment subjects are admitted to the clinic. Their insulin pump and infusion set is replaced by the investigational system, a commercially available insulin pump and either the intradermal infusion set (Research Catheter Set, BD) or the subcutaneous infusion set (Quick Set, Medtronic)to include an in-line pressure transducer/recorder and insulin NovoRapid. The initial pump infusion rate is established based on the patient's known basal infusion rate and the meal bolus insulin is estimated based on the patient's known insulin sensitivity. An intravenous (in the vein) catheter line is established, blood glucose is measured at least every 2 hours overnight and insulin corrections can be implemented, if deemed necessary. The overnight and pre-prandial (before meal) target range is 70-160 mg/dl, although the procedure will continue as planned if the patient is outside the range. It should be the goal not to give any IV glucose or insulin at all, and not to change basal insulin settings for at least 2 hours before the meal. The breakfast meal will be a high GI (60g carbohydrates) solid meal, to be consumed within 15 minutes and followed for a period of 6 hours of blood sampling for glucose and insulin levels. Lunch will be served as standardized mixed meal, and followed for a period of 4-6 hours. This procedure is repeated on days 2 and 3 whereas the breakfast and lunch meal as well as the insulin dose to cover the meal are the same. A light evening dinner is served every day, composition and insulin dose to be recorded. On day three after the 4 hour period following lunch the catheter will be removed, catheter and site assessments will be documented and an ultrasound observation of the infusion site (skin thickness and SC) versus an adjacent control site will be performed within 10 min after removal of the infusion set. Glucose rescue, if necessary, will be administered orally (juice, 200 mL). Insulin correction boli should be delivered via the investigational infusion set.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradermal - BD Research Catheter Set | Experimental | Device: Intradermal delivery via the BD Research Catheter SetIntradermal delivery of insulin (basal and bolus delivery) using the BD Research Catheter Set with 34G x 1.5 mm side-ported needle and the Animas Vibe insulin pump over a three day period. |
| Subcutaneous - Medtronic Quick-Set | Active comparator | Device: Subcutaneous delivery via Medtronic Quick-SetSubcutaneous delivery of insulin (basal and bolus delivery) using the Medtronic Quick Set with 6 mm Teflon catheter and the Animas Vibe insulin pump over a three day period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male and Female patients will be included in the trial only if they fulfill all the inclusion criteria mentioned below:
- Understood and signed informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the patient)
- Type 1 Diabetes mellitus, according to clinical judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year.
- Usage of insulin pump therapy (CSII) with carb counting for at least six months
- Age in the range of ≥ 18 and ≤ 55 years
Key exclusion criteria (20 listed)
- Patients will not be permitted to enter the trial, if they fulfill any of the exclusion criteria mentioned below:
- Previous participation in this trial or participation in a clinical trial within 3 months prior to screening examination
- Any symptoms suggestive of, or a diagnosis or treatment for gastroparesis
- Abnormalities in renal function (e.g. serum creatinine > 120 µmmol/L for male, >100 µmmol/L for female subjects or judged by the investigator that would pose a problem of clearance of injected insulin
- Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
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 |
|---|---|---|
| Subcutaneous delivery via Medtronic Quick-SetAlso: insulin infusion setInfusion rates and pre-meal bolus doses will be based on subjects known daily infusion rate and subject's reported insulin to carbohydrate ratio. | Device | Subcutaneous - Medtronic Quick-Set |
| Intradermal delivery via the BD Research Catheter SetAlso: microneedles, insulin infusion setInfusion rates and pre-meal bolus doses will be based on subjects known daily infusion rate and subject's reported insulin to carbohydrate ratio. | Device | Intradermal - BD Research Catheter Set |
Primary outcome
Insulin levels
Time frame: 0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days
Time to peak plasma concentration (Tmax) of insulin delivered intradermally as compared to insulin delivered subcutaneously after a meal bolus.
8 secondary outcomes
Insulin levels
Time frame: 0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days
Blood Glucose
Time frame: 0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days
Device performance - adhesion
Time frame: Evaluated at every timepoint a bolus injection is given
Skin thickness using ultrasound
Time frame: Upon removal of the device (within 5 minutes)
Device performance - Leakage of fluid (insulin) at injection site
Time frame: Immediatley before and after each bolus injection and immediatly upon removal of the device at the end of the study period.
Device performance-pump alarm
Time frame: over the 3 study days
Skin effects-Draize Scoring for Skin Irritation
Time frame: Following removal of the device (within 2 minutes) and 1 and 2 hours (+/- 5 minutes) post removal.
Number of participants with adverse events
Time frame: up to 53 days or until the subject is discharged, if sooner.
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 26 Jul 2012.
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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.
Christoph Kapitza, MD principal investigator
Profil Institut fur Stoffwechselforschung (GmbH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Subcutaneous delivery via Medtronic Quick-Set and Intradermal delivery via the BD Research Catheter Set in people with Diabetes, run by Becton, Dickinson and Company at 1 site in Germany.
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 10 inclusion and 20 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 26 Jul 2012. 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 Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Insulin levels (time frame: 0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2012.