NCT04233034 · OUTCOME

Number of Participants With CGM Time in Range 70-180 mg/dL >=70% at 52 Weeks

Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes · Source last updated 2024-11-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 52 Weeks

What was measured

Percentage of patients with \>=70% sensor glucose values from 70 to 180 mg/dL between treatment groups

Analysis population: N missing in each group are as follows; HCL (N=2 at 52 weeks); Non-HCL (N=4 at 52 weeks); Verapamil (N=3 at 52 weeks); Placebo (N=3 at 52 weeks).

Groups in this outcome

HCL and Intensive Management

Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] HCL: Hybrid Closed Loop therapy verapamil

Non-HCL and Standard Care

Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] non-HCL: Usual diabetes care

Verapamil

Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] verapamil 120mg tablet: verapamil tablet

Placebo

Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] placebo: placebo pill manufactured to mimic verapamil 120mg tablet

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
HCL and Intensive Management	59
Non-HCL and Standard Care	47
Verapamil	44
Placebo	37

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
HCL and Intensive Management	46	Not reported	Not reported	Not reported	Not reported
Non-HCL and Standard Care	22	Not reported	Not reported	Not reported	Not reported
Verapamil	30	Not reported	Not reported	Not reported	Not reported
Placebo	23	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.21
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.53
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.001
param Type
Risk Difference (RD)
param Value
0.38
statistical Method
Regression, Logistic
ci Lower Limit
-0.26
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.32
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value
0.79
param Type
Risk Difference (RD)
param Value
0.03
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
0.21
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.53
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.001
param Type
Risk Difference (RD)
param Value
0.38
statistical Method
Regression, Logistic
ci Lower Limit
-0.26
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.32
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value
0.79
param Type
Risk Difference (RD)
param Value
0.03
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
value
46
group Id
OG001
value
22
group Id
OG002
value
30
group Id
OG003
value
23

denoms

counts
group Id
OG000
value
59
group Id
OG001
value
47
group Id
OG002
value
44
group Id
OG003
value
37
units
Participants

description

Percentage of patients with \>=70% sensor glucose values from 70 to 180 mg/dL between treatment groups

groups

description
Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] HCL: Hybrid Closed Loop therapy verapamil
id
OG000
title
HCL and Intensive Management
description
Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] non-HCL: Usual diabetes care
id
OG001
title
Non-HCL and Standard Care
description
Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] verapamil 120mg tablet: verapamil tablet
id
OG002
title
Verapamil
description
Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] placebo: placebo pill manufactured to mimic verapamil 120mg tablet
id
OG003
title
Placebo

param Type

COUNT_OF_PARTICIPANTS

population Description

N missing in each group are as follows; HCL (N=2 at 52 weeks); Non-HCL (N=4 at 52 weeks); Verapamil (N=3 at 52 weeks); Placebo (N=3 at 52 weeks).

reporting Status

POSTED

time Frame

52 Weeks

title

Number of Participants With CGM Time in Range 70-180 mg/dL >=70% at 52 Weeks

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice