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Type 1 DiabetesPhase 1CiQ-SGLT2NCT04201496

SGLT2 Inhibitor Adjunctive Therapy to Closed Loop Control in Type 1 Diabetes Mellitus

A Phase 1 study of Type 1 Diabetes, run by Ananda Basu, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary purpose of this study is to evaluate the safety and efficacy of combining SGLT2 inhibitors with closed loop control (CLC). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
24 Feb 2020to 7 Sep 2021
Phase
Phase 1
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18.0 and ≤65 years old at time of consent
  • Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
  • Currently using an insulin pump for at least six months
  • Currently using insulin for at least six months
  • Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
  • Access to internet and willingness to upload data during the study as needed
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  • For females, not currently known to be pregnant or breastfeeding
  • If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  • Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
  • Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
  • Total daily insulin dose (TDD) at least 10 U/day
  • Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
  • Willingness to eat at least 100 grams of carbohydrates per day
  • An understanding and willingness to follow the protocol and signed informed consent
  • Pilot Participants: Agree to hotel/research house admission with other Pilot participants on a date selected by the study team.

Who cannot join

  • Hemoglobin A1c >9%
  • History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
  • Pregnancy or intent to become pregnant during the trial
  • Currently breastfeeding or planning to breastfeed
  • Currently being treated for a seizure disorder
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  • Planned surgery during study duration
  • History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
  • Clinically significant electrocardiogram (ECG) abnormality at time of Screening, as interpreted by the study medical physician
  • Use of diuretics (e.g. Lasix, Thiazides)
  • History of chronic or recurrent genital infections
  • eGFR lab value below 60 mL/min/1.73 m2
  • Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
  • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
  • Severe renal impairment, end-stage renal disease, or dialysis
  • Inpatient psychiatric treatment in the past six months
  • Presence of a known adrenal disorder
  • Abnormal liver function test results (Transaminase>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
  • Uncontrolled thyroid disease
  • Severe renal impairment, end-stage renal disease, or dialysis
  • Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team
  • Current enrollment in another clinical trial, unless approved by the investigator of both studies or if clinical trial is a non-interventional registry trial
  • Alcohol restricted to no more than 2 drinks per night in men and no more than 1 drink per night in women
  • Low carb diet (less than 100g per day)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia, Center for Diabetes Technology

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

The primary purpose of this study is to evaluate the safety and efficacy of combining SGLT2 inhibitors with closed loop control (CLC).

Read the detailed description

The first five participants will be enrolled in a Pilot Study to use the Basal-IQ with Empagliflozin 10 mg daily for approximately two weeks. These participants will participate in an estimated 36-48-hour hotel admission to initiate use of Closed Loop Control. The safety data from the Pilot Study will be presented to the Data Safety Monitoring Board (DSMB) for review.

Upon DSMB approval, approximately 40 participants will be randomized 1:1 in a crossover design. Participants will use empagliflozin 5 mg daily. This main study is a randomized control trial where approximately 50 participants, aged 18 to less than 65 y.o. at time of consent, will be in the trial for up to 10 weeks.

With empagliflozin:

  • Control-IQ (CiQ) x 4 weeks (CiQ-EMPA) then Basal-IQ x 2 weeks (BiQ-EMPA)
  • Basal-IQ x 2 weeks (BiQ-EMPA) then CiQ x 4 weeks (CiQ-EMPA)

Without empagliflozin:

  • CiQ x 4 weeks (CiQ-NO EMPA) then Basal-IQ x 2 weeks (BiQ-NO EMPA)
  • Basal-IQ x 2 weeks (BiQ-NO EMPA) then CiQ x 4 weeks (CiQ-NO EMPA)
Conditions
Type 1 Diabetes
Being tested
Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks, Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks, No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks, No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks
Keywords
Artificial Pancreas (AP), Sodium-glucose co-transporter 2 (SGLT2) inhibitor, Insulin Pumps, Continuous Glucose Monitor (CGM), Closed Loop Control, Low blood glucose index (LBGI), High blood glucose index (HBGI)
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.

  • Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wksCombination product

    Participants with be provided with Empagliflozin to take daily for approximately 10 weeks. Along with the study medication, participants will initially use the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks.

  • Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wksCombination product

    Participants with be provided with Empagliflozin to take daily for approximately 10 weeks. Along with the study medication, participants will initially use the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks.

  • No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wksDevice

    Participants will initially use the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks. Empaglizflozin will not be provided to this group.

  • No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wksDevice

    Participants will initially use the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks. Empaglizflozin will not be provided to this group.

Study groups in NCT04201496
Study groupRoleWhat they receive
Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wksExperimentalControl-IQ x 4 weeks (CiQ-EMPA) then Basal-IQ x 2 weeks (BiQ-EMPA)
Receives: Combination Product: Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks
Empagliflozin + Basal-IQ x 2 wks then CiQ x 4 wksExperimentalBasal-IQ x 2 weeks (BiQ-EMPA) then Control-IQ x 4 weeks (CiQ-EMPA)
Receives: Combination Product: Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks
No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wksActive comparatorControl-IQ x 4 weeks (CiQ-NO EMPA) then Basal-IQ x 2 weeks (BiQ-NO EMPA)
Receives: Device: No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks
No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wksActive comparatorBasal-IQ x 2 weeks (BiQ-NO EMPA) then Control-IQ x 4 weeks (CiQ-NO EMPA)
Receives: Device: No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CGM-measured time in the target range 70-180mg/dl (TIR) during the day

    CGM-measured time in the target range 70-180mg/dl (TIR) during the day

    Measured: 6 weeks

Secondary outcomes (14)

  1. Time below 70 mg/dl

    Time below 70 mg/dl

    Measured: 6 weeks

  2. Time above 180 mg/dl

    Time above 180 mg/dl

    Measured: 6 weeks

  3. Time between 70-140 mg/dl 5 hours post prandial

    Time between 70-140 mg/dl 5 hours post prandial

    Measured: 6 weeks

  4. Glucose variability index HBGI

    Glucose variability index HBGI

    Measured: 6 weeks

  5. Glucose variability index LBGI

    Glucose variability index LBGI

    Measured: 6 weeks

  6. Glucose variability index ADRR

    Glucose variability index ADRR

    Measured: 6 weeks

  7. Safety evaluation of empagliflozin as adjuvant therapy added to a closed loop artificial pancreas system

    Number of episodes of diabetic ketoacidosis (DKA)

    Measured: 6 weeks

  8. Safety evaluation of empagliflozin as adjuvant therapy added to a closed loop artificial pancreas system

    Number of episodes of severe hypoglycemia (glucose <50 mg/dl)

    Measured: 6 weeks

  9. Episodes of diabetes ketoacidosis (DKA)

    The number of DKA events in the experimental group as compared to the control group

    Measured: 6 weeks

  10. Episodes of severe hypoglycemia (glucose <50 mg/dL)

    The number of hypoglycemic events in the experimental group as compared to the control group

    Measured: 6 weeks

  11. Genital infections

    Number of genital infections (balanitis, urethritis, vulvar infections, Fournier's gangrene) that occur in the experimental group versus the control group

    Measured: 6 weeks

  12. Urinary Tract Infections

    Number of urinary tract infections that occur in the experimental group versus the control group

    Measured: 6 weeks

  13. Total amount of insulin used

    The number of amount of insulin used in the experimental group as compared to the control group

    Measured: 6 weeks

  14. Number of hyperglycemic episodes as defined by contiguous CGM above 300 mg/dL

    Number of hyperglycemic episodes, defined as contiguous CGM values above 300 mg/dL, that occur in the experimental group versus the control group

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2019
  2. Study start24 Feb 2020
  3. Primary completion7 Sep 2021
  4. Study completion7 Sep 2021

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Participants will be first randomized to taking empagliflozin or not taking this drug. Participants will then be randomized to using the Basal-IQ insulin pump first or the Control-IQ insulin pump first. Participants then transition to using the other pump. With empagliflozin: * Control-IQ x 4 weeks (CiQ-EMPA) then Basal-IQ x 2 weeks (BiQ-EMPA) * Basal-IQ x 2 weeks (BiQ-EMPA) then Control-IQ x 4 weeks (CiQ-EMPA) Without empagliflozin: * Control-IQ x 4 weeks (CiQ-NO EMPA) then Basal-IQ x 2 weeks (BiQ-NO EMPA) * Basal-IQ x 2 weeks (BiQ-NO EMPA) then Control-IQ x 4 weeks (CiQ-NO EMPA)
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04201496
Sponsor's protocol ID
190017
Other IDs
DP3DK106785
Acronym
CiQ-SGLT2
Status last verified
Aug 2022
First submitted
4 Nov 2019
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: To be determined

Publications

  • Garcia-Tirado J, Farhy L, Nass R, Kollar L, Clancy-Oliveri M, Basu R, Kovatchev B, Basu A. Automated Insulin Delivery with SGLT2i Combination Therapy in Type 1 Diabetes. Diabetes Technol Ther. 2022 Jul;24(7):461-470. doi: 10.1089/dia.2021.0542. Epub 2022 Mar 14.

    PubMed 35255229

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Type 1 Diabetes, run by Ananda Basu, MD at 1 site in United States.

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 15 inclusion and 24 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 11 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 States. 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 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.

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?

CGM-measured time in the target range 70-180mg/dl (TIR) during the day (time frame: 6 weeks). 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 NCT04201496, which also lists 1 linked publication.

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 11 Aug 2022.

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